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"Spotlight"

Spotlight

"Spotlight"

Drugs to avoid in 2026

Editorial Prescrire has published its fourteenth consecutive review of drugs to avoid. This annually updated review, with supporting references, identifies drugs that are more dangerous than beneficial in all the clinical situations in which they are authorised in France or in the European Union.
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Enfortumab vedotin (Padcev°) + pembrolizumab (Keytruda°) in unresectable or metastatic urothelial carcinoma

Marketing Authorisations Enfortumab vedotin, a cytotoxic drug conjugated to an anti-nectin-4 monoclonal antibody, was already authorised for use as third-line treatment in locally advanced or metastatic urothelial cancer. It is now also authorised in first-line treatment in combination with pembrolizumab.
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Sotatercept (Winrevair°) in pulmonary arterial hypertension

Marketing Authorisations Sotatercept has been authorised in the European Union for use in adults with pulmonary arterial hypertension, as an add-on to other drugs. Does sotatercept extend survival in these patients? Does it reduce functional impairment and slow disease progression? And what are its adverse effects?
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Anabolic androgenic steroids: cardiac events and venous thromboembolism

Adverse effects In 2025, a Danish team investigated the risk of cardiovascular disease in men who were attending fitness centres and taking anabolic androgenic steroids to enhance physical performance.
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mRNA covid-19 vaccines: a review of adverse effects (continued)

Adverse effects At the time of our literature search, in mid-2025, several reviews of reported adverse effects of mRNA covid-19 vaccines analysed by European and French drug regulatory agencies were available, with a follow-up of about 4.5 years.
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Drugs to avoid in the name of better patient care: 2026 update

DRUGS TO AVOID - 2026 UPDATE To make it easier to choose high-quality care, and to prevent disproportionate harm to patients, Prescrire has published its annual update of drugs to avoid on the basis that they are more dangerous than beneficial.
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Retracted articles continue to do harm

Editorial More and more articles are being retracted by their authors or by scientific journals as a result of errors or fraud discovered post-publication (1-3). Particularly noteworthy examples include a paper by a Marseille-based group of researchers on the effects of using hydroxychloroquine in combination with azithromycin to treat covid-19. With nearly 3200 citations, it is the second most highly cited retracted article in the world (4).
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Fezolinetant (Veoza°) for menopause-related hot flushes

Marketing Authorisations Fezolinetant has been authorised in the European Union to treat moderate to severe vasomotor symptoms associated with menopause. In this situation, how effective is fezolinetant against hot flushes compared with menopausal hormone therapy? Is it effective in women who cannot receive menopausal hormone therapy? Do symptoms rebound when fezolinetant is discontinued? And what are its adverse effects?
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Momelotinib (Omjjara°) in myelofibrosis

Marketing Authorisations The immunosuppressant momelotinib has been authorised in the European Union for use in patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Does momelotinib extend survival in these patients? Does it alleviate symptoms more than existing drugs, particularly ruxolitinib? And what are its adverse effects?
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Cabergoline: fibrotic disorders and heart valve disease

Adverse effects Quinagolide, a non-ergot dopamine agonist used in hyperprolactinaemia, has been withdrawn from the market in several European countries. This will probably lead to an increase in the number of patients exposed to the ergot-derived dopamine agonists bromocriptine and cabergoline.
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Adverse effects of nirsevimab: limited data after one season of use in infants

Adverse effects Nirsevimab is a monoclonal antibody, authorised since 2023 for the prevention of infection with respiratory syncytial virus (RSV) in neonates and infants. Between September 2023 and April 2024, about 2 million children were exposed to nirsevimab worldwide. In September 2024, the French Health Products Agency (ANSM) published the report of a pharmacovigilance survey covering the period from September 2023 to April 2024.
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Stand strong together

Editorial Looking at current events in France, Europe, and around the world in 2025, these are uncertain, even menacing, times, as was already the case in many countries in 2024. The global consensus forged after World War II is under threat; free trade agreements that were supposed to contribute to peace and prosperity were torn up from one day to the next by the president of the very country that imposed them on the rest of the world.
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Attenuated chikungunya vaccine (Ixchiq°)

Marketing Authorisations The first chikungunya vaccine to have been authorised in the European Union is a live attenuated virus derived from a strain isolated on Reunion Island in 2006. Is this vaccine effective at preventing chikungunya infections and their complications? Does it slow transmission during an epidemic? Is it useful for travellers visiting an area where chikungunya is endemic? And what are its adverse effects?
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Iptacopan (Fabhalta°) in paroxysmal nocturnal haemoglobinuria

Marketing Authorisations Paroxysmal nocturnal haemoglobinuria is a rare, potentially fatal condition in which patients produce red blood cells that are unusually susceptible to haemolysis. Treatment is mainly based on blood transfusions and intravenous eculizumab or ravulizumab. Iptacopan has been authorised in the European Union as an oral treatment for adults with paroxysmal nocturnal haemoglobinuria with haemolytic anaemia.
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Weekly methotrexate: evaluation of risk minimisation measures commissioned by the European Medicines Agency

Outlook The European Medicines Agency (EMA) recently commissioned a private company to evaluate the "risk minimisation measures" it has introduced to reduce errors related to taking or injecting methotrexate at daily instead of weekly intervals. The impact of these measures was found to be modest at best.
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Pregnancy and "disease-modifying" drugs for multiple sclerosis: what are the consequences for the unborn child?

Adverse effects Multiple sclerosis is a disease of the central nervous system that usually follows a relapsing-remitting course. It often affects women and generally starts between the ages of 20 and 40 years. As of 2025, what is known about the consequences for the unborn child of exposure to the main disease-modifying drugs currently authorised in France for use in pregnant women with multiple sclerosis? This article reviews the main data we identified through our literature search.
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Drug residues in water: the pharmaceutical industry haggling over their removal

Editorial Among various European directives on water pollution, the revised Urban Wastewater Treatment Directive came into force in early 2025. The pharmaceutical industry is seeking to dodge its obligations.
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Gefapixant (Lyfnua°) in refractory or unexplained chronic cough

Marketing Authorisations Gefapixant, an antagonist of the purinergic receptors P2X3 and P2X2/3, has been authorised in the European Union for use in adults with refractory or unexplained chronic cough. Does gefapixant alleviate the symptoms or complications of chronic cough? Does it stop patients from coughing or reduce cough frequency? And what are its adverse effects?
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Alectinib (Alecensa°) as first-line treatment in advanced or metastatic ALK-positive non-small cell lung cancer

Marketing Authorisations The initial marketing authorisation for the use of alectinib in patients with advanced or metastatic non-small cell lung cancer harbouring an ALK mutation was based on the preliminary results of two comparative randomised trials, called "Alex" and "Alur". More results from these trials, with longer follow-up, have become available since the evaluation published in our French edition in 2018.
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Semaglutide (Wegovy°) in excess body weight: sometimes useful for patients who also have a history of cardiovascular disease

Marketing Authorisations The glucagon-like peptide 1 (GLP-1) agonist semaglutide was authorised in the European Union in 2021 for use in certain patients with overweight or obesity. At that time, in the absence of the results of the ongoing "Select" trial evaluating the effect of semaglutide versus placebo on the cardiovascular complications of excess body weight, it was preferable that these patients not count on this drug and that the focus be placed instead on a comprehensive (non-pharmacological) approach. Results from the Select trial were published in a scientific journal in 2023, and then presented in Prescrire International. In 2024, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which have access to far more data than those presented in medical journals, published their public reports on the Select trial online.
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Drug-induced impulse control disorders: an insight into the devastating effects on patients' lives

Adverse Effects An analysis of reports of adverse drug reactions involving pramipexole or aripiprazole, recorded in the US pharmacovigilance database, showed that 7.5% and 4.5% of reports, respectively, included an impulse control disorder such as pathological gambling, hypersexuality, impulsivity, compulsive shopping or hyperphagia.
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Clinical evaluation of medical devices: as of 2025, progress is difficult to ascertain and weaknesses persist

Outlook The reforms culminating in the 2017 Medical Devices Regulation did not take into account the calls from Prescrire, among others, for the creation of a European Medical Devices Agency.
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Victims of health products: a European opportunity to be seized

Editorial The 1985 Product Liability Directive established the rules to be followed by member states of the European Union regarding the liability of health product companies when a safety issue arises with their products. The new 2024 version of this directive is more favourable to the victims of such products.
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Bedaquiline (Sirturo°) in first-line treatment for pulmonary multidrug-resistant tuberculosis

Marketing Authorisations During the initial evaluation of bedaquiline in patients with pulmonary multidrug-resistant tuberculosis, the main trial had shown bacteriological efficacy, but also higher mortality. Since then, several randomised trials in hundreds of patients have shown that, compared with the drug combinations previously recommended by the WHO, the use of combinations including bedaquiline make it possible to shorten the duration of treatment by several months, while providing similar bacteriological efficacy and resulting in similar mortality.
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Insulin icodec (Awiqli°) in type 1 or type 2 diabetes

Marketing Authorisations Insulin icodec is a long-acting analogue of human insulin, designed for once-weekly subcutaneous injection. It differs from human insulin by a few amino acids and the addition of a fatty acid to one of the insulin chains. It has been authorised in the European Union for use in adults with type 1 or type 2 diabetes. Does insulin icodec represent a therapeutic advance over the long-acting insulins available for once-daily use?
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Caftors: liver function abnormalities and possibly cataracts in breastfed infants

Adverse Effects In 2024, a French team reported elevated plasma levels of liver enzymes, and sometimes bilirubin, in 3 exclusively breastfed infants whose mothers had taken the combination of ivacaftor + tezacaftor + elexacaftor throughout pregnancy and continued treatment while breastfeeding.
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Drug-induced sleep apnoea

Adverse Effects Sleep apnoea is sometimes caused by drugs, but there has been little evaluation of this adverse effect. When a patient develops sleep apnoea, it is important to ask oneself whether a drug could be responsible, and whether their current treatment should be modified.
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European drug regulatory agencies: strategy through to 2028

Advancing Healthcare Policy The proposed priorities focus too much on new technologies, and not enough on seeking therapeutic advances for patients.
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EMA: handling the competing interests of its experts

Advancing Healthcare Policy Prescrire has contributed to a public consultation organised by the European Medicines Agency on its new policy for handling the competing interests of scientific committee members and experts.
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Pricing of new drugs: deadlock

Editorial Is it possible for countries to provide access to new, very expensive drugs while balancing the books of their health insurance system? The pharmaceutical industry's pursuit of maximum profits is making it increasingly difficult to reconcile these competing pressures.
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Relugolix + estradiol + norethisterone acetate (Ryeqo°) in endometriosis

Marketing Authorisations Endometriosis is a condition related to the presence of uterine mucosal tissue (endometrium) outside of the uterus. When paracetamol or a nonsteroidal anti-inflammatory drug are not sufficient to relieve endometriosis-related pain, a hormonal contraceptive or an intrauterine device (IUD) that delivers levonorgestrel are options. Relugolix, a GnRH antagonist that induces menopausal symptoms, combined with an oestrogen-progestogen combination intended to attenuate these symptoms, is already authorised for the treatment of uterine fibroid symptoms, a situation in which it has an unfavourable harm-benefit balance. It is now also authorised for the treatment of endometriosis symptoms.
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Live attenuated cholera O1 vaccine (Vaxchora°)

Marketing Authorisations The mainstay of cholera prevention and control is to improve access to clean drinking water, sewage systems and personal hygiene. A live attenuated cholera O1 vaccine has been authorised in the European Union under the brand name Vaxchora°. For people living in countries where cholera is endemic or causes epidemics or travellers visiting such countries, is this vaccine more effective than the other available cholera vaccines? And what are its adverse effects?
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PD-1 or PD-L1 immune checkpoint inhibitors: cholangitis

Adverse Effects In 2024, a French team published an analysis of 48 reports of cholangitis attributed to a PD-1 or PD-L1 immune checkpoint inhibitor, recorded in the national pharmacovigilance database. 4 patients died, 2 from liver injury.
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Long-term PPI treatment: increased incidence of gastric cancer and gastric cancer recurrence

Adverse Effects In 2023, in two cohort studies including about 300 000 patients who had received at least one treatment for Helicobacter pylori infection, the risk of gastric cancer was about 4-fold greater in patients with the most exposure to PPIs than in those who had little or no exposure.
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Antineoplastic drugs that do not represent a therapeutic advance: still highly profitable

Outlook Antineoplastic drugs that provide little or no progress for patients are nonetheless significant sources of revenue for pharmaceutical companies: between 1995 and 2020, these drugs generated half as much revenue as those that represented a major therapeutic advance.
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Anti-competitive practices: a very "inventive" pharmaceutical industry

Outlook A total of €780 million in fines was imposed in the European Union over the period 2018-2022. More than half of this sum related to a case in France that has been appealed by the companies concerned.
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New drugs: improve information about uncertainties

Editorial When new drugs enter the market, there is (sometimes great) uncertainty about their efficacy and adverse effects (1).
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Inclisiran (Leqvio°) in certain types of hypercholesterolaemia

Marketing Authorisations Inclisiran is a "small interfering" RNA intended to reduce LDL cholesterol levels in the blood. It has been authorised in the European Union for use in primary or secondary cardiovascular prevention for patients with hypercholesterolaemia, in whom statins are considered insufficiently effective or cannot be used. Does inclisiran reduce the incidence or severity of the cardiovascular complications of hypercholesterolaemia in these situations? Does it represent a therapeutic advance over alirocumab or evolocumab? And what are its adverse effects?
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Abaloparatide (Eladynos°) in postmenopausal osteoporosis

Marketing Authorisations In postmenopausal women, the main strategies for preventing fractures due to bone fragility are fall prevention and regular physical exercise. When pharmacological prevention is chosen, the first-choice option is a bisphosphonate such as alendronic acid. Abaloparatide, a parathyroid hormone agonist with a similar mechanism of action to teriparatide, has been authorised in the European Union for use in postmenopausal women with osteoporosis who are at "increased" risk of fracture.
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High cumulative doses of opioids during pregnancy: long-term neuropsychiatric harms in exposed children

Adverse Effects When a pregnant woman experiences pain that is severe or not relieved by paracetamol, an opioid is sometimes justified. In 2024, new data were published on the long-term neurodevelopmental and neuropsychiatric harms of in-utero exposure to opioids.
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Antineoplastic drugs + PPIs: shorter survival

Adverse Effects What are the main evaluation data on the risk of excess mortality with concomitant exposure to an antineoplastic drug and a proton pump inhibitor? To what extent do these data help in making healthcare decisions?
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Conflicts of interest in European health technology assessments

Advancing Healthcare Policy Prescrire contributed to a public consultation organised by the European Commission on the procedures for managing conflicts of interest in joint health technology assessments.
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EMA: protecting personal data and commercially confidential information

Advancing Healthcare Policy Prescrire participated in a public consultation organised by the European Medicines Agency (EMA) on the protection of personal data and commercially confidential information in marketing authorisation applications.
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EMA: assessing the risks of drugs for human reproduction and lactation

Advancing Healthcare Policy Prescrire participated in a consultation on the revision of the "Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation".
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Management of conflicts of interest at the EMA: chronic failure

Editorial In late 2024, the European Medicines Agency (EMA) pushed through a public consultation on its policy for handling competing interests of the experts it calls upon to participate in various Agency activities. The EMA has long fallen short in its management of conflicts of interest (1).
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GLP-1 agonists: depression, suicidal thoughts or behaviour (continued)

Adverse Effects In late 2023, based on our analysis of the available clinical evaluation data and pharmacovigilance data, it appeared prudent to consider that GLP-1 agonists, such as semaglutide and liraglutide, carry a risk of depression, suicidal thoughts, suicide attempts or suicide. What more is known about these risks as of 2025?
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Calcium supplementation: cardiovascular risks (continued)

Adverse Effects In 2013, the divergent results of various trials and studies identified by Prescrire suggested an approximately 30 percentage-point increase in cardiovascular risk with calcium supplementation. What more is known about this risk as of 2025?
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Tirzepatide in heart failure in adults with obesity

Marketing Authorisations The dual GLP-1 and GIP agonist tirzepatide is authorised in the European Union by subcutaneous injection for use in certain adults with type 2 diabetes, and in certain patients with obesity or overweight. Here, we examine the published results of a double-blind randomised placebo-controlled trial of tirzepatide in 731 adults with obesity and heart failure with preserved ejection fraction.
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Melatonin (Adaflex°, Voquily°) in insomnia in children with ADHD

Marketing Authorisations Patients with attention deficit hyperactivity disorder (ADHD) often have sleep disorders. Two melatonin-containing medicines have been authorised in France and elsewhere for use in insomnia in children and adolescents with ADHD in whom non-pharmacological measures have been insufficiently effective. Does melatonin improve sleep in this situation? Does it alleviate patients' behavioural and cognitive disorders, or improve the quality of life of the children concerned and their families? And what are its adverse effects?
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Update to the Declaration of Helsinki

Advancing Healthcare Policy Prescrire contributed to a consultation organised by the World Medical Association on the latest revision of this global reference for clinical trial ethics.
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A "prescription" from French civil society for a new pharmaceutical policy

Advancing Healthcare Policy Prescrire and 13 other health sector organisations have published a joint "prescription" to ensure access to medicines at an affordable cost.
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French Senate resolution on the European "pharmaceutical package"

Advancing Healthcare Policy Prescrire gave evidence to the French Senate as it prepared a resolution on the revision of European pharmaceutical legislation.
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The finances of Association Mieux Prescrire: 2024 annual report

Outlook Association Mieux Prescrire, the legal entity that publishes Prescrire's publications and continuing education programmes, makes its accounts public every year. The summary of its 2024 annual financial report is publicly available here.
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Why drugs should be evaluated in several randomised comparative trials

Editorial Every year, the Prescrire Drug Awards are based on the reviews published in the Marketing Authorisations section of Prescrire's French edition over the past year. For the 2024 Prescrire Drug Awards, as in previous years, we chose not to give awards to certain drugs that were evaluated in a single comparative trial, even when the trial showed the drug to represent a therapeutic advance for patients. Examples include: darolutamide, for use in combination with docetaxel in certain metastatic prostate cancers; and dostarlimab, for use in combination with first-line chemotherapy in certain endometrial cancers. What is the reason for this choice?
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The Prescrire Drug Awards for 2024

Prescrire awarded one Pilule d'Or (Golden Pill) this year, to a drug for a neglected disease. One other drug was deemed "Noteworthy". Although some of the other drugs analysed in Prescrire over the course of 2024 represented a therapeutic advance for certain patients, especially in the field of oncology, we chose not to give them an award because their clinical evaluation was insufficiently robust (see "Why drugs should be evaluated in several randomised comparative trials" Prescrire Int May 2025, FREE).
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Linzagolix (Yselty°) in uterine fibroids

Marketing Authorisations Linzagolix, an oral GnRH antagonist, like relugolix, has been authorised in the European Union as a symptomatic treatment for uterine fibroids. To prevent the menopausal symptoms it induces, the company recommends adding an oestrogen-progestogen combination.
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Cabotegravir (Apretude°) in HIV pre-exposure prophylaxis (PrEP)

Marketing Authorisations Cabotegravir, an HIV integrase inhibitor, administered by intramuscular injection, is already authorised in the European Union under the brand name Vocabria° for use in combination with rilpivirine in HIV-infected patients. It is now also authorised as monotherapy under the brand name Apretude°.
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Myocarditis linked to messenger RNA covid-19 vaccines (continued)

Adverse Effects This article summarises the main data identified in our literature search, conducted in early 2025, concerning the prognosis of myocarditis linked to mRNA covid-19 vaccines.
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Sagas

Editorial Metamizole (also known as dipyrone) is an analgesic and antipyretic drug that exposes patients to a risk of fatal agranulocytosis of unpredictable onset. In late 2024, the European Commission decided to maintain metamizole-containing medicines on the European market.
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Fexinidazole (Fexinidazole Winthrop°) in sleeping sickness caused by Trypanosoma brucei rhodesiense

Marketing Authorisations In 2018, the European Medicines Agency (EMA) evaluated the nitroimidazole antiparasitic drug fexinidazole in the treatment of trypanosomiasis due to T. brucei gambiense. In this situation, the drug represented a major therapeutic advance, with high efficacy at both stages of the disease. More recently, the EMA evaluated fexinidazole in the treatment of human African trypanosomiasis due to T. brucei rhodesiense.
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Esketamine (Spravato°) in depression after failure of several antidepressants or with a high risk of suicide?

Marketing Authorisations The publication in 2023 of results from the trial comparing esketamine to quetiapine provides an opportunity to review the evaluation data on esketamine in the situations for which it is authorised. Since our 2022 analysis, what more is known about the efficacy of esketamine in comparison to that of other treatments? What more is known about its adverse effects?
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SSRI antidepressants and venlafaxine: increased risk of injuries

Adverse Effects A study using French healthcare data, in which each patient acted as their own control, showed that the risk of hospitalisation for an injury (such as a fracture) was about 1.5-fold greater during the first 2 weeks of treatment with escitalopram or paroxetine compared to periods without exposure to these drugs. This difference was statistically significant. Similar results were found with venlafaxine.
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Prescrire's ratings of new drugs in 2024

Marketing Authorisations One major therapeutic advance, a few practical advances for children, but otherwise many new products or indications of little value this year.
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Artificial intelligence: critical thinking is lacking

Outlook A risk of large-scale disinformation, yet wholly inadequate safeguards.
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Public- versus private-sector research: what do they bring to the table?

Editorial How important is the contribution of public-sector or academic research to the development of new medicines? In comparison with research conducted in the private sector by pharmaceutical companies, does it lead to more drugs that represent a therapeutic advance?
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Exagamglogene autotemcel (Casgevy°) in beta-thalassaemia or sickle-cell disease

Marketing Authorisations Exagamglogene autotemcel is the first gene therapy product using the CRISPR-Cas9 system to have been granted marketing authorisation in the European Union. It is indicated in certain patients with severe forms of beta-thalassaemia or sickle-cell disease. Is it curative in these patients? Does it eliminate the need for blood transfusions and iron chelators in severe beta-thalassaemia, does it eliminate vaso-occlusive crises and their complications in sickle-cell disease, and what are its adverse effects?
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Ritlecitinib (Litfulo°) in severe alopecia areata in adults and adolescents

Marketing Authorisations Ritlecitinib is an immunosuppressant that inhibits various kinases, including Janus kinases. It has been authorised in the European Union for the treatment of adults and adolescents with severe alopecia areata.
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Children exposed to progestogens in utero: excess cancers?

Adverse Effects In June 2024, the European pharmacovigilance committee (PRAC) recommended that marketing authorisation for products containing hydroxyprogesterone should be suspended, due to the lack of proven efficacy in preventing preterm birth and the risk of cancer in children exposed in utero. Other progestogens, including progesterone, are authorised for the prevention of spontaneous abortion early in pregnancy. What are the main data concerning the risk of cancer in children exposed to a progestogen in utero?
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Anticoagulants and heavy menstrual bleeding

Adverse Effects According to 2 cohort studies published in 2022 and 2023, 2 out of 3 women under 50 years of age on anticoagulant treatment for venous thromboembolism or pulmonary embolism have troublesome heavy menstrual bleeding, with sometimes major consequences for their everyday lives. In this situation, the insertion of an intrauterine device containing levonorgestrel usually reduces the volume of menstrual blood loss, with largely acceptable adverse effects.
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Errors related to brand names: the EMA can still do more

Advancing Healthcare Policy In March 2022, Prescrire responded to a public consultation launched by the European Medicines Agency (EMA) in preparation for the 7th revision of its guideline on the acceptability of brand names for drugs authorised via the centralised procedure. The new version of this guideline was published in December 2023. For drugs that are the subject of a European marketing authorisation application, the EMA is stepping up its efforts to prevent medication errors related to brand names. But it still does not encourage systematic use of international nonproprietary names.
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Take action

Editorial Many drugs that have been marketed for decades have become such a part of routine practice that they are taken for granted. Some are useful, with demonstrated efficacy and an acceptable adverse effect profile. Some others have no demonstrated clinical value beyond that of a placebo, and it is debatable whether they should remain on the market.
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Drugs to avoid in the name of better patient care: 2025 update

DRUGS TO AVOID - 2025 UPDATE To make it easier to choose high-quality care, and to prevent disproportionate harm to patients, Prescrire has published its annual update of drugs to avoid on the basis that they are more dangerous than beneficial.
Full article (11 pages) available for download (FREE)

Dostarlimab (Jemperli°) in advanced or recurrent endometrial cancer with DNA repair defects

Marketing Authorisations Dostarlimab is an immunostimulatory anti-PD-1 antibody that has been authorised in the European Union for use in patients with advanced or recurrent mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer, either in first-line treatment in combination with carboplatin and paclitaxel, or in second-line treatment as monotherapy.
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Mavacamten (Camzyos°) in hypertrophic cardiomyopathy?

Marketing Authorisations Mavacamten, described as a selective and reversible inhibitor of cardiac myosin, has been authorised in the European Union in the treatment of symptomatic obstructive hypertrophic cardiomyopathy in adults. Does it extend survival in this situation, alleviate the symptoms of the disease (especially compared with a beta blocker or a calcium-channel blocker), reduce the incidence of serious complications, and avert the need for heart surgery? And what are its adverse effects?
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Intravitreal VEGF inhibitors: systemic adverse effects

Adverse Effects A pharmacovigilance survey carried out by the French Health Products Agency (ANSM) identified 130 reports of cardiovascular adverse effects, mainly stroke, in patients treated with an intravitreal VEGF inhibitor. Two epidemiological studies, one conducted in the US and the other in Taiwan, quantified the risk of cardiovascular or kidney disease associated with intravitreal exposure to VEGF inhibitors.
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The WHO urges governments to stand up to health-harming corporations

Editorial In 2024, the World Health Organization (WHO) published a new landmark document that is both a review of the scientific literature and a political analysis, in the broad sense of the term, this time on the health-harming effects of the products and practices of certain sectors of industry (1-5).
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RSVPreF3/AS01E vaccine (Arexvy°) in the prevention of RSV infections from 60 years of age

Marketing Authorisations The adjuvanted RSVPreF3/AS01E vaccine is the first vaccine authorised in the European Union for the prevention of RSV-associated lower respiratory tract infections in adults aged 60 years or older. Does it prevent respiratory infections in this population? Does it reduce hospitalisations and mortality? And what are its adverse effects?
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Valoctocogene roxaparvovec (Roctavian°) in haemophilia A?

Marketing Authorisations The gene therapy product valoctocogene roxaparvovec consists of a non-replicating adeno-associated virus serotype 5 (AAV5)-based vector that contains a DNA sequence encoding a variant of human factor VIII. It has been authorised in the European Union for the treatment of adults with severe haemophilia A on the basis of weak non-comparative data that suggest efficacy, but which declines over time.
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Neuroleptics in patients with dementia: serious adverse effects

Adverse Effects In 2024, a study using a British general practice database, linked to hospitalisation and mortality data, investigated several known adverse effects of neuroleptics in patients with dementia who were aged 50 years or older.
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Dupilumab in severe asthma in children: helpful and without risk of infections or cancer?

Queries and Comments Following the publication of Prescrire's analysis of evaluation data for dupilumab (Dupixent°) in severe asthma in children aged 6 years or older (Prescrire Int October 2023), members of Crisalis, an international clinical research network studying severe asthma, wrote to express their differing conclusions on dupilumab's benefits and harms in this situation.
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Revision of European pharmaceutical legislation: an opportunity to transform the system of R&D incentives

Outlook In the context of the ongoing revision of European pharmaceutical legislation, a report by the European Parliament's Panel for the Future of Science and Technology has set out options for major changes to Europe's pharmaceutical research and development (STOA) system. Here, Prescrire publishes excerpts from the report's insightful analyses providing clarifications in the form of editors' notes.
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Too many scientific articles continue to be cited after their retraction

Outlook About 60 out of 100 000 articles are retracted after publication. Unfortunately, those who read or cite them are not always aware of their retracted status.
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Paradigm(s)

Editorial For decades, the pharmaceutical industry has encouraged patients, students, healthcare professionals and drug regulatory agencies to adopt a way of thinking about drugs focused on their efficacy, trivialising the issue of adverse effects and sometimes even obscuring the dangers they pose to patients.
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Ivosidenib (Tibsovo°) in the first-line treatment of acute myeloid leukaemia with an IDH1 mutation

Marketing Authorisations Ivosidenib has been authorised in the European Union, in combination with azacitidine, for the first-line treatment of adult patients with acute myeloid leukaemia and an IDH1 mutation, for whom high-dose cytotoxic chemotherapy is unsuitable. Due to their concurrent development, the azacitidine + ivosidenib combination has not been compared to the azacitidine + venetoclax combination.
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Levetiracetam in utero: long-term effects more clearly defined

Adverse effects Levetiracetam is an antiepileptic drug for which no particular safety signal has been reported following exposure as monotherapy during the first trimester of pregnancy. As of mid-2024, what is known about the consequences of in-utero exposure to levetiracetam in terms of neuropsychiatric developmental disorders?
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Long-term methylphenidate use: cardiovascular disorders

Adverse effects According to a study based on Swedish healthcare registers, in adults and children with attention deficit hyperactivity disorder, the risk of cardiovascular disorders increases with the duration of exposure to methylphenidate. After 3 to 5 years of exposure, the risk was increased by about 30%. The risk of hypertension appears to double beyond 5 years of exposure.
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Mediator° disaster: the damning appeal judgement

Outlook In late December 2023, the Paris appeal court found the pharmaceutical company Servier guilty of all the criminal offences of which it was accused: "aggravated deception", "aggravated involuntary bodily harm and manslaughter", "fraud" and "improperly obtaining" and subsequently renewing marketing authorisation for benfluorex (Mediator°, since withdrawn). Prescrire has published excerpts from the 1101-page judgement, illustrating the position of the appeal judges on Servier's culpability.
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New data after marketing authorisation: European Commission consultation (continued)

Advancing Healthcare Policy In September 2023, Prescrire responded to a consultation organised by the European Commission prior to revising the "Variations Regulation".
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EMA: two surveys about the patient leaflet

Advancing Healthcare Policy In December 2023 and February 2024, Prescrire responded to two surveys organised by the European Medicines Agency (EMA) for the purposes of revising the template that serves as a basis for the patient leaflet (package leaflet) provided with medicinal products and of improving its content and structure.
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European pharmaceutical legislation: too many opportunities missed

Editorial On 10 April 2024, members of the European Parliament (MEPs) held a plenary vote on the European Commission's proposals for the revision of European pharmaceutical legislation. Overall, despite a number of welcome advances, MEPs failed to take full advantage of this opportunity to strengthen drug evaluation and patient safety.
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Herpes zoster vaccine gE/AS01B (Shingrix°)

Marketing Authorisations The main complication of herpes zoster is persistent neuropathic pain, which can last for months or even years. Immunocompromised patients are at higher risk of developing this complication. Attenuated varicella-zoster virus vaccine is contraindicated in immunocompromised patients, due to the risk of infection with the attenuated virus. A protein vaccine has now been authorised for the prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 years or older and in adults at increased risk of herpes zoster from 18 years of age.
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Tirzepatide (Mounjaro°) in type 2 diabetes

Marketing Authorisations A tirzepatide solution for subcutaneous injection has been authorised in the European Union for use in adults with type 2 diabetes, either as monotherapy when metformin use is considered inappropriate, or in combination with other glucose lowering-drugs. In these situations, is tirzepatide more effective than a GLP-1 agonist in preventing the complications of diabetes? And what are its adverse effects?
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Hormonal contraception + NSAIDs: deep vein thrombosis and pulmonary embolism

Adverse Effects A study using Danish healthcare data examined the risk of venous thromboembolism in women who were concomitantly using a hormonal contraceptive and a nonsteroidal anti-inflammatory drug (NSAID) other than aspirin.
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Risankizumab (Skyrizi°) in Crohn's disease after failure of at least one other immunosuppressant

Marketing Authorisations When a corticosteroid and "conventional" immunosuppressive treatments such as azathioprine are unsatisfactory in a patient with moderate to severe Crohn's disease, adalimumab (an anti-TNF-alpha monoclonal antibody) or ustekinumab (an anti-interleukin-12 and anti-interleukin-23 monoclonal antibody) are immunosuppressants of choice. The anti-interleukin-23 monoclonal antibody risankizumab has also been authorised for use in this situation, or when second-line immunosuppressants have failed.
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Revision of European pharmaceutical legislation: a disappointing vote in the Parliament

Advancing Healthcare Policy In April 2024, MEPs voted on the European Commission's proposals for the revision of European pharmaceutical legislation. Overall, despite a number of welcome advances, MEPs failed to take advantage of the opportunity to strengthen drug evaluation and patient safety.
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French Senate hearing on drug shortages

Advancing Healthcare Policy Prescrire gave evidence to the Senate as it prepared a resolution on European pharmaceutical legislation.
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DSM: still riddled with conflicts of interests

Editorial The American Psychiatric Association (APA) has been producing successive versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) since 1952. The aim of the DSM is to propose a definition for every psychiatric disorder.
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Finerenone (Kerendia°) in chronic kidney disease with albuminuria associated with type 2 diabetes

Marketing Authorisations Patients with type 2 diabetes are at risk of microvascular disease, which can lead to kidney failure. The aldosterone receptor antagonist finerenone has been authorised in the European Union for use in patients with type 2 diabetes who have developed chronic kidney disease with albuminuria. Does finerenone reduce mortality or the incidence of end-stage kidney disease in this situation? And what are its adverse effects?
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Solifenacin + tamsulosin (Vecalmys°/Vesomni°) in benign prostatic hyperplasia: not acceptable

Marketing Authorisations A fixed-dose combination of the antimuscarinic drug solifenacin and the alpha-1 blocker tamsulosin has been authorised in France and some other European countries to relieve the symptoms of benign prostatic hyperplasia when monotherapy (of any kind) has been considered insufficiently effective.
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Environmental impact of drugs: taking drug utilisation data into account

Outlook Drug residues have been detected in surface water and groundwater in countries around the world. The main source of residues of drugs for human use in the environment is excretion in the urine and faeces. A team of Swedish and Italian researchers has developed a tool for predicting the environmental impact of drugs that takes drug utilisation data into account.
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European "pharmaceutical package": letter on clinical data exclusivity

Advancing Healthcare Policy Prescrire was a cosignatory of a letter sent to members of the European Parliament asking them not to extend the regulatory protection afforded to originator medicinal products.
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Short-term interruption of treatment with a xaban or dabigatran: sometimes fatal thrombosis

Adverse Effects A study based on a South Korean health insurance database, including 11 000 patients with atrial fibrillation who were treated with a xaban-type oral anticoagulant or dabigatran and followed up for one year, showed that treatment interruption, even for one day, was associated with a 2-fold increase in the risk of premature death and a 10-fold increase in the risk of stroke, transient ischaemic attack or systemic embolism.
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Phasing out patient leaflets in paper form: eco-responsible or irresponsible?

Editorial In 2023, the European Commission embarked on a thorough revision of Europe's pharmaceutical legislation. One of the proposed changes is to gradually phase out package leaflets in paper format and replace them with an electronic version.
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Selinexor (Nexpovio°) in relapsed or refractory multiple myeloma: not acceptable

Marketing Authorisations For patients with relapsed or refractory multiple myeloma, various combinations of antineoplastic drugs extend survival. Selinexor, an exportin-1 inhibitor, has been authorised in the European Union for use in multiple myeloma: in combination with bortezomib and dexamethasone after at least one line of treatment; and in combination with dexamethasone after at least four lines of treatment.
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Bupropion + naltrexone (Mysimba°) for weight loss: set to be withdrawn from the market in the European Union?

Marketing Authorisations The pharmaceutical company Orexigen Therapeutics has failed to fulfil its obligation to conduct a post-authorisation trial to assess the long-term cardiovascular adverse effects of the fixed-dose combination of bupropion + naltrexone (Mysimba°), which is authorised in the European Union for use in patients with obesity or who are overweight. Now, 9 years after its authorisation, the European Commission has asked the European Medicines Agency to review its harm-benefit balance.
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In-utero exposure to corticosteroids: increased risk of serious infections during the first year of life

Adverse Effects A study using Taiwanese healthcare databases, including about 2 million children, assessed the risk of infection linked to in-utero exposure to a corticosteroid prescribed to prevent prematurity-related respiratory distress syndrome. The risk of hospitalisation for a serious infection during the first year of life appeared to be about 25% greater in the exposed children.
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Prescrire's review of drug packaging in 2023: reconciling ease of use with safety is an ongoing challenge

Drug packaging can be considered high quality if it makes the drug safer and easy to use, and if it is designed to protect people who come into contact with the patient from the risk of poisoning, especially children.
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Prescrire's contribution to the EMA's consultation on the "Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials"

Advancing Healthcare Policy In the interests of patients, Prescrire's contribution emphasises two points that are fundamental to the quality and safety of health care, and that the EMA must take into account while developing its forthcoming guideline on "non-inferiority" trials.
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European Commission: lobbyists block nutritional labelling

Editorial Nutri-Score is a labelling system for food and beverages that informs consumers about the product's nutritional quality. The label is displayed on food packaging on a voluntary basis by manufacturers, and by supermarket chains on their own-brand products.
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Dupilumab (Dupixent°) in prurigo nodularis

Marketing Authorisations Dupilumab, an immunosuppressive monoclonal antibody directed against interleukin-4 and interleukin-13 receptors, has been authorised in the European Union for the treatment of prurigo nodularis, a condition that can greatly impair patients' quality of life.
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Netarsudil (Rhokiinsa°) or netarsudil + latanoprost (Roclanda°) in chronic glaucoma: not acceptable

Marketing Authorisations Eye drops containing netarsudil, alone or combined with latanoprost, have been authorised in the European Union to lower intraocular pressure in adults with chronic open-angle glaucoma or ocular hypertension. Netarsudil exposes patients to a higher risk of adverse effects than the first-choice ocular antihypertensive drugs, timolol or latanoprost, while offering no demonstrated gain in efficacy.
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Zanubrutinib (Brukinsa°) in certain haematological malignancies

Marketing Authorisations Zanubrutinib has been authorised for use in chronic lymphocytic leukaemia and Waldenström macroglobulinaemia (as has ibrutinib), and in certain patients with relapsed or refractory marginal zone lymphoma. Does zanubrutinib extend survival compared with the other options used in these situations, in particular ibrutinib? Does it have fewer or less severe adverse effects than ibrutinib?
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Methadone: an analysis of adverse effects reported in France

Adverse Effects Methadone, a long-acting opioid, is used for the treatment of opioid dependence and as an analgesic. A French regional pharmacovigilance centre analysed, over a 10-year period, 509 reports of adverse effects in patients exposed to methadone, of which 8 out of 10 were serious. By being aware of the situations in which the use of methadone carries a risk of serious adverse effects, these situations can be anticipated.
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Mediator° trial appeal: a judgement that better reflects the harm done

Outlook French appeal court finds Servier guilty of four charges, handing down sentences more respectful of the victims of decades of constant, organised deception.
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New data after marketing authorisation: European Commission consultation

Advancing Healthcare Policy Prescrire has contributed to a public consultation on the proposed revision of the rules governing variations to marketing authorisations, submitted to take into account new data, for example on efficacy or a new adverse effect.
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Non-comparative trials for marketing authorisations: EMA consultation

Advancing Healthcare Policy Prescrire has contributed to a consultation on the use of non-comparative clinical trials to obtain marketing authorisation.
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Drug shortages: Prescrire calls for transparency

Advancing Healthcare Policy In a joint letter to the European Commission, Prescrire, the European Public Health Alliance (EPHA) and France Assos Santé have called for medicine manufacturers and wholesalers to keep the EU's national drug regulatory agencies informed about stock levels.
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A tale of risk

Editorial Each drug has its own story. Some are fine tales of discovery: the discovery of a rare or not so rare disease, its serious or not so serious consequences, its natural course and causes, and then an effective treatment. In the best stories, the treatment benefits numerous patients for a very long time, its risks are considered acceptable, and the price society pays for it is fair.
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Faricimab (Vabysmo°) in age-related macular degeneration or diabetic macular oedema

Marketing Authorisations Faricimab is a monoclonal antibody that simultaneously targets 2 proteins involved in angiogenesis: vascular endothelial growth factor (VEGF) and angiopoietin-2. It has been authorised in the European Union for intravitreal use in adults with neovascular (wet) age-related macular degeneration and in adults with loss of visual acuity due to diabetic macular oedema. What advantages does faricimab offer over VEGF inhibitors in these clinical situations? And what are its adverse effects?
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Semaglutide in secondary cardiovascular prevention in overweight or obese patients

Marketing Authorisations In a placebo-controlled trial in patients at high risk for cardiovascular events, their incidence was 1.5 percentage points lower in the injectable semaglutide group than in the placebo group, with no reduction in mortality and at a cost of frequent, and often troublesome, adverse effects.
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Recurring criticisms of Prescrire: how do we answer?

Outlook Ever since Prescrire was launched in 1981, it has been criticised for its method of analysis, editorial process and certain editorial choices. This article addresses a few of the recurring criticisms levelled against Prescrire.
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Paternal exposure to valproate drugs in the period prior to conception: neurodevelopmental disorders in children?

Adverse Effects In 2023, epidemiological data suggesting an increased incidence of neurodevelopmental disorders in children whose father had taken a valproate drug during the 3 months prior to conception led several drug regulatory agencies to issue alerts about this potential risk. As of early 2024, what are the main evaluation data concerning this risk, how strong is the evidence they provide, and to what extent should they be taken into account in clinical practice?
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The finances of Association Mieux Prescrire: 2023 annual report

Outlook Association Mieux Prescrire, the legal entity that publishes Prescrire's journals and continuing education programmes, makes its accounts public every year. The summary of its 2023 annual financial report is publicly available here.
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Check before deciding

Editorial Many people take medicines regularly for months or even years. If their condition worsens or a new health problem develops, other medicines are often added. When prescribing, advising, dispensing or administering an additional drug, it is essential to consider the adverse effects that could result from interactions with the patient's current medications.
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Tezepelumab (Tezspire°) in severe asthma in adults and adolescents

Marketing Authorisations Tezepelumab is a monoclonal antibody that binds to the cytokine thymic stromal lymphopoietin. It has been authorised in the European Union for use in adults and adolescents with severe asthma, as an add-on to insufficiently effective maintenance treatment with a high-dose inhaled corticosteroid combined with at least one other drug. In this situation, is tezepelumab more effective than an oral corticosteroid or any of the other monoclonal antibodies authorised in asthma, does it help reduce patients’ oral corticosteroid requirements, and what are its adverse effects?
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The Prescrire Drug Awards for 2023

None of the drugs examined by Prescrire in 2023 represented a major therapeutic advance worthy of a Pilule d'Or (Golden Pill Award). Only one drug received an award, earning a place on the Honours List.
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Pregabalin during the first trimester of pregnancy: probably a slight increase in major malformations

Adverse Effects New pharmacoepidemiological data show a higher incidence of various major congenital malformations following in-utero exposure to pregabalin than in control groups. What is the evidence for this risk, and what are the consequences in practice?
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Efgartigimod alfa (Vyvgart°) in generalised myasthenia gravis

Marketing Authorisations Efgartigimod alfa, an antibody Fc fragment that is claimed to increase IgG degradation by blocking the neonatal Fc receptor, has been authorised in the European Union as an add-on treatment in adults with generalised myasthenia gravis who have autoantibodies directed against acetylcholine receptors. Is efgartigimod alfa more effective at alleviating the symptoms of the disease than the other treatments proposed in this situation, does it prevent the complications of the disease, including myasthenic crisis, and what are its adverse effects?
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European Commission public consultation on the revision of European pharmaceutical legislation: Prescrire's response

Advancing Healthcare Policy The European Commission has launched a major revision of European pharmaceutical legislation. In November 2023, it opened its proposals to public consultation, to which Prescrire has responded. While Prescrire welcomes several of the proposals, some of them need to be further developed. Others are counterproductive or even dangerous, and should be rejected.
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Bad in food but fine in health products?

Outlook Bisphenol A and titanium dioxide: the European Medicines Agency (EMA) disputes the need to remove these substances from health products, yet it is acknowledged that their presence in food is harmful.
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Evaluating drugs for today's patients, without neglecting tomorrow's patients

Editorial The quantity and quality of information available about new drugs when they first enter the market has declined considerably in recent years, to the point where a group of drug evaluation specialists and healthcare professionals issued a warning about this situation in a French national newspaper in spring 2023. At the same time, certain patients' organisations criticised France's National Authority for Health (HAS) for “deadly decisions” which they claim delay access to purportedly promising new drugs.
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RSVpreF vaccine (Abrysvo°) during pregnancy to prevent RSV infection in the woman's child after birth

Marketing Authorisations RSVpreF vaccine was authorised in the European Union in mid-2023 for pregnant women between weeks 24 and 36 of gestation, to prevent respiratory syncytial virus (RSV) infection in their children from birth to 6 months of age. Does maternal vaccination during pregnancy provide more effective protection for infants, or provoke fewer or milder adverse effects, than the administration of nirsevimab or palivizumab to the infant?
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Prescrire's ratings of new drugs in 2023

Marketing Authorisations In 2023, therapeutic advances were rare, and mainly benefit cancer patients. Most newly authorised products or indications offered no advantages over existing options, and a few were more dangerous than beneficial, especially for children.
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GLP-1 agonists: depression, suicidal thoughts or behaviour?

Adverse effects In July 2023, the European pharmacovigilance committee (PRAC) decided to launch a review of GLP-1 agonists, following reports of suicidal thoughts and thoughts of self-harm. To what extent do GLP-1 agonists expose patients to a risk of depression, suicidal ideation, attempted suicide or suicide? This article summarises the main findings of our search of the literature for answers to this question.
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Is Prescrire overly alarmist about conditional marketing authorisations?

Outlook Following the publication (in Prescrire International n° 246) of an Editors’ Opinion on the withdrawal of the conditional marketing authorisation for rucaparib (Rubraca°) in certain types of ovarian cancer, we received a letter from a senior official at the European Medicines Agency (EMA). This letter provides us with the opportunity to review the issues and risks associated with “conditional” marketing authorisations.
(see also "Winners and losers" Prescrire Int n° 246, subscribers only)
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First version of the European list of critical medicines: Prescrire's comments

Outlook A lack of transparency that the authors could swiftly rectify to allay concerns over how the list was compiled and why certain medicines are missing.
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40 years without sales representatives

Editorial One method used by companies to promote their health products is through sales representatives who meet with healthcare professionals at their place of work, otherwise known as detailing. Prescrire has been documenting the harmful effects of the biased information spread through this practice and its impact on prescribing for 40 years now.
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Voxelotor (Oxbryta°) in sickle-cell disease

Marketing Authorisations Voxelotor binds to haemoglobin and increases its affinity for oxygen. It is claimed that this prevents sickling and premature destruction of red blood cells. A reduction in oxygen release by haemoglobin would be expected in its presence. Voxelotor has been authorised in the European Union for the treatment of haemolytic anaemia due to sickle-cell disease, as monotherapy or in combination with hydroxycarbamide. In this situation, does voxelotor correct the clinical effects of anaemia or reduce the the incidence of complications of sickle-cell disease?
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Pregabalin and gabapentin: sometimes fatal overdoses

Adverse effects Various studies have confirmed that pregabalin overdose carries a risk of coma and respiratory depression. The risk of overdose is increased in patients with renal impairment. The severity of such overdoses is increased when pregabalin is combined with a central nervous system depressant such as an opioid. Gabapentin also carries a risk of overdose in the presence of renal impairment.
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Intranasal fentanyl (Instanyl° Doseguard°): finally made safer

Marketing Authorisations The new multidose presentation of fentanyl solution for intranasal administration, Instanyl° DoseGuard°, is safer for patients than the former presentation, as it is equipped with a safety cap, an electronic dose counter, and a mechanism to temporarily prevent any further administration within a given time period.
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Medical devices mimicking medicinal products: the European Court of Justice confirms a strict stance

Outlook In early 2023, the European Court of Justice upheld a legal ruling from Germany challenging the status of two medical devices that consisted exclusively of chemical substances and resemble medicinal products. Certification bodies or authorities are justified in denying medical device status to products of this kind for which a lack of pharmacological action has not been demonstrated.
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Leave my placenta alone!

Editorial Prescrire has a longstanding interest in the consequences of drug exposure during pregnancy, for both the woman and the unborn child. This interest extends to women who are not yet aware they are pregnant, and to the long-term consequences of in-utero drug exposure, in particular on the child's development.
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Olaparib (Lynparza°) as "maintenance" therapy for certain advanced ovarian cancers after first-line chemotherapy

Marketing Authorisations Olaparib is authorised as "maintenance" treatment (with or without bevacizumab) in women with certain ovarian cancers following first-line chemotherapy. In both authorised clinical situations, the initial authorisation was based on a single double-blind randomised clinical trial, with an interim analysis showing no reduction in mortality after a median follow-up of about 40 months. As of mid-2023, longer-term results are available from both of these trials.
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Clomifene: serious, sometimes irreversible, vision disorders

Adverse effects In 2023, a US team published a case report of a 39-year-old woman who had, for 3 days, been taking 100 mg per day of clomifene (Clomid° or other brands), an oestrogen agonist/antagonist used to treat infertility by inducing ovulation. The woman described visual disturbances characterised by a blurry trail of multiple images persisting behind her hand as she moved it across her field of view.
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Drugs that interfere with the placenta and affect the fetus

Adverse effects The consequences of drug use on the placenta remain little studied as of 2023. Pharmacological knowledge about the substance in question helps to predict its impact on placental development and function, at all stages of pregnancy.
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European Commission: taken to task by the Ombudsman for lack of transparency

Outlook Following complaints on excessive response times, the European Ombudsman has reminded the European Commission that EU citizens have the right to access administrative documents and that access delayed is access denied.
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Drugs to avoid in the name of better patient care: 2024 update

DRUGS TO AVOID - 2024 UPDATE To make it easier to choose high-quality care, and to prevent disproportionate harm to patients, Prescrire has published its annual update of drugs to avoid.
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Revision of European pharmaceutical legislation

Outlook The European Parliament is set to vote on a proposed new regulation and directive in spring 2024. Prescrire has proposed a number of amendments.
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Safety signals: why bother?

Editorial A drug is a serious affair. With serious medical and ethical aspects, as well as economic and financial implications, to consider. It is the culmination of lengthy laboratory-based and clinical research. When the first safety signal appears, it would be unreasonable to tear down all that has been accomplished and waste all of the economic benefits at the drop of a hat.
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Abemaciclib (Verzenios°), palbociclib (Ibrance°) and ribociclib (Kisqali°) added to an aromatase inhibitor in certain breast cancers

Marketing Authorisations Abemaciclib, palbociclib and ribociclib have been authorised since the late 2010s for use in postmenopausal women with locally advanced or metastatic breast cancer, whose tumour cells express hormone receptors but do not overexpress the HER2 protein. According to the initial clinical evaluation of each of these CDK 4/6 inhibitors ("ciclibs"), none of them extended survival, while an increased incidence of serious adverse effects was reported. With longer follow-up, does the addition of a CDK 4/6 inhibitor to an aromatase inhibitor extend survival? And what more is known about their adverse effects?
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When the cause of a disorder is not immediately obvious: could a drug be responsible?

Outlook The potential role of a drug in the onset of a disorder is often overlooked or rarely considered. Yet many disorders are sometimes drug-induced, and in some cases this aetiology was long unsuspected or considered unlikely. This article discusses a few examples of clinical situations for which a drug-related cause was initially considered unlikely, but became credible over time.
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Prescribing cascades: recognise them and take corrective action

Adverse effects Using a systematic literature review, a research team identified situations in which a drug was prescribed to treat a disorder caused by another drug. Nine prescribing cascades turned out to be particularly problematic in older patients, due to their clinical consequences, the frequency with which the drugs involved were prescribed, or the severity of their potential adverse effects, yet alternatives were available.
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When to take a safety signal into account: Prescrire's experience

Outlook A large number of safety signals, suggesting the existence of previously unknown or incompletely documented adverse effects, can be found in numerous publications from a wide variety of sources. How can healthcare professionals tell which signals are worth taking into account in order to provide better patient care? This article is based on Prescrire's experience and continuous monitoring of the literature.
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Defending the right to compensation for the victims of drug-induced harms

Advancing Healthcare Policy Prescrire and France Assos Santé have proposed a series of amendments to members of the European Parliament working on the revision of the 1985 European Product Liability Directive.
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Patient characteristics

Editorial The best treatment option in a given clinical situation is the one that offers the best balance between efficacy and harm, making it the most suitable option for most patients. For most patients, but not all. Because sometimes a patient characteristic shifts this balance to a point where another treatment would be more suitable.
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Nirsevimab (Beyfortus°) to prevent RSV infection in infants

Marketing Authorisations Palivizumab was the first drug to receive European marketing authorisation for the prevention of RSV infection. Its use is restricted to certain infants at increased risk of developing severe disease. Nirsevimab, another monoclonal antibody directed against the RSV F protein, has been authorised for the prevention of RSV infection in neonates and infants, including those who have no risk factors for developing severe disease. Does nirsevimab reduce the incidence of severe RSV disease or death compared with palivizumab in infants with risk factors, or compared with placebo in healthy full-term infants?
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Negative post-marketing trials: often ignored

Outlook Accelerated or conditional marketing authorisation pathways are designed to speed up patient access to potential therapeutic advances. But when post-marketing trials conducted to evaluate these drugs using clinical endpoints do not confirm the pre-authorisation trial results obtained using surrogate endpoints, drug regulatory agencies and the organisations responsible for cancer guidelines rarely take these negative results into account.
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Ustekinumab (Stelara°): no live vaccines before 6 months of age for infants who have been exposed in utero

Adverse Effects Infants exposed in utero to an immunosuppressant such as ustekinumab are, as a result, susceptible to serious infections for several months after birth if they are given a vaccine containing live attenuated bacteria or viruses.
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Zonisamide: as dangerous as topiramate during pregnancy?

Adverse Effects The EMA has concluded that a pregnancy test should be "considered" before initiating treatment with zonisamide. Its close pharmacological similarity to topiramate, which has established teratogenic effects, plus the few available data, indicate the need for caution in women who are, or could become, pregnant.
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France's health technology assessment body: pushed to lower the bar!

Outlook The HAS's new principles for rating drugs, designed to facilitate access to new treatments, allow lower-quality evaluation. This may not be in patients' best interests.
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Drugs to avoid: an analysis of Australia’s pharmaceuticals market

Outlook A study by Australian academics, based on Prescrire’s annual review of drugs to avoid.
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Proposed multi-stakeholder platform to improve clinical trials in the European Union

Advancing Healthcare Policy Prescrire has responded to the consultation on the proposed key priorities for the platform, but chose not to apply for membership, in order to safeguard its independence.
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Flexibility

Editorial Healthcare professionals often specify how and when medicines should be taken when prescribing, dispensing or administering them, whether or not this information is included in the patient leaflet. These instructions are usually based on information provided in the summary of product characteristics, but is the level of evidence sufficiently strong to serve as a basis for hard and fast rules?
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Tebentafusp (Kimmtrak°) in metastatic uveal melanoma

Marketing Authorisations Tebentafusp, a fusion protein consisting of a T cell receptor fused to an anti-CD3 antibody fragment, has been authorised in the European Union for the treatment of metastatic or inoperable uveal melanoma, in HLA-A*02:01-positive patients. About half of the population of western Europe are HLA-A*02:01-positive. Does tebentafusp extend survival in this situation? And what are its adverse effects?
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Biotin: misleading thyroid function test results

Adverse Effects Biotin, present in dietary supplements in particular, can lead to false results with serum-based thyroid function tests.
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Evaluation of new drugs and medical devices in Europe: a highly critical report from the KCE

Outlook In late 2021, the Belgian Health Care Knowledge Centre (KCE) published a detailed and highly critical report assessing the conditions under which new drugs and medical devices enter the European market. The report includes a list of recommendations for ensuring that the different stakeholders involved (patients, healthcare professionals, health technology assessment agencies, reimbursement approval bodies and payers) have access to the necessary comparative evaluations before new health products enter the market.
Full article (2 pages) available for download by subscribers

When should levodopa be taken: with meals or between meals?

Queries and Comments Different sources (summaries of product characteristics, prescribing information) give very different recommendations on how to take levodopa, the first-choice drug for reducing the motor disorders of Parkinson’s disease. Prescrire's answer to a volunteer from a French patient group points out the absence of robust clinical evaluation data and proposes a pragmatic approach.
Full article available for download by subscribers

Diclofenac: also harmful for the environment

Outlook Diclofenac, a drug with widespread presence in the environment, has well-demonstrated environmental toxicity. Another reason not to choose diclofenac.
Full article available for download (free)

Remdesivir (Veklury°) in covid-19 at increased risk of progression to severe disease, or in children on oxygen

Covid-19 In a double-blind randomised placebo-controlled trial in 562 unvaccinated patients with covid-19 (before the emergence of the Omicron variant of Sars-CoV-2) who did not require supplemental oxygen, a 3-day course of remdesivir reduced the proportion of patients hospitalised for acute care over the 28-day follow-up period. It is unclear whether these results can be transposed to the epidemiological context of 2023 in which a high proportion of the population has been immunised through vaccination or prior infection with Sars-CoV-2, and Omicron is by far the most dominant variant.
Full article available for download by subscribers

No regard for patients!

Editorial Risperidone for monthly injection (Okedi°) was granted marketing authorisation on the basis of a randomised placebo-controlled trial in patients experiencing an acute exacerbation of schizophrenia (see “Risperidone as monthly injections” Prescrire Int n° 252 > Subscribers only). This placebo-controlled trial was doubly disgraceful.

Rimegepant (Vydura°) in migraine

Marketing Authorisations Rimegepant is another CGRP receptor antagonist, with a chemical structure completely different from that of the monoclonal antibodies initially available. It is the first CGRP inhibitor to be authorised in the European Union for oral administration, both for the treatment and prevention of migraine attacks.
Full article (4 pages) available for download by subscribers

Lenacapavir (Sunlenca°) in multidrug-resistant HIV-1 infection

Marketing Authorisations Lenacapavir is an antiretroviral drug that binds to the HIV-1 capsid. This disrupts various steps in the HIV lifecycle in which the capsid plays a role, such as transport of the viral genome into the nucleus of an infected cell, integration of the viral genome, and assembly of various viral components. It is the first antiretroviral with this mechanism of action to have been authorised in the European Union.
Full article (3 pages) available for download by subscribers

Cannabidiol: sometimes serious adverse effects, and multiple drug interactions

Adverse Effects Cannabidiol (CBD), a cannabinoid, is naturally present in cannabis. Cannabidiol is used as an antiepileptic. Some CBD-containing products are sold without the regulatory status of medicines, and sometimes also contain other cannabinoids.
Full article (1 page) available for download by subscribers

Drug shortages: patients lose out, healthcare professionals waste time

Outlook Drug shortages expose patients to a risk of serious, sometimes fatal, adverse effects, medication errors, and worsening of their disease. In daily practice, the workload of healthcare professionals is increased, with harmful consequences for the healthcare system, exacerbating an already fragile situation. In 2020-21, using the French pharmacovigilance database, France’s regional pharmacovigilance centres (CRPV) carried out a study on the consequences of drug shortages.
Full article (2 pages) available for download by subscribers

Prescrire: a cosignatory of letters to various European institutions

Advancing Healthcare Policy In late 2022, Prescrire was a cosignatory of letters to three institutions in Europe: the Council of the European Union, the European Patent Office, and the European Parliament's Special Committee tasked with evaluating the handling of the covid-19 pandemic.

Publication of clinical trial protocols

Advancing Healthcare Policy In a joint letter to the European Medicines Agency's Management Board, Prescrire contested an Agency plan that would delay publication of the protocols of drug trials.

Practicalities

Editorial A drug is more than just an active substance mixed with excipients. There is more to consider than its pharmacological properties or its economic success. A drug is also a physical product that is part of the patient's daily life. And its packaging components, such as its box, the blister packs, bottle, vial or syringe, and the patient leaflet, are an integral part of this.

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Marketing Authorisations Nivolumab, a monoclonal antibody directed against PD-1, has been authorised for patients with metastatic or inoperable gastric or oesophageal adenocarcinoma or squamous cell carcinoma. In these situations, does nivolumab represent a therapeutic advance compared to the treatments already available, and, in particular, does it extend survival?
Full article (3 pages) available for download by subscribers

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Adverse Effects In 2022, a French research team published a case-control study which investigated the association between exposure to a GLP-1 receptor agonist and the risk of developing thyroid cancer.
Full article available for download by subscribers

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Marketing Authorisations Glucarpidase has been granted marketing authorisation in the European Union for reducing plasma concentrations of methotrexate in patients who have received high-dose methotrexate for cancer treatment when elimination is delayed due to impaired renal function. In this situation, does glucarpidase reduce an excessively high plasma concentration of methotrexate? Does it limit the serious dose-dependent adverse effects of this cytotoxic drug? And what are its adverse effects?
Full article (2 pages) available for download by subscribers

Prescrire's annual review of drug packaging: progress is too slow

A drug's packaging contains a set of components for use by patients, their caregivers and healthcare professionals. It is important that packaging is well designed with a view to ease of use and the prevention of errors with dangerous consequences.
Full article (4 page) available for download (free)

R&D costs: secrecy at every level

In France, the pharmaceutical industry has managed to turn a law to ensure transparency about the public funding it receives into a promotional opportunity.
Full article available for download (free)

Conditional marketing authorisation: easier to grant than to revoke

Progesterone is ineffective at preventing preterm delivery, but proved difficult to withdraw from the market. It is not the only example of this phenomenon.
Full article available for download (free)

Interdisciplinary collaboration

Editorial Many healthcare professionals routinely provide care for a specific patient by working together or as part of a multidisciplinary team. When well organised, such collaborations are synergistic, and beneficial for patients.

Daridorexant (Quviviq°) in insomnia

Marketing Authorisations The clinical evaluation of daridorexant in patients with chronic insomnia was not designed to demonstrate a potential advance compared with already available sleep-inducing drugs. While its mechanism of action is indeed different, there is no evidence that it represents a tangible clinical advance for patients.
Full article (4 pages) available for download by subscribers

Clinical trials in children: many results go unreported

A group of US researchers have determined the proportion of clinical trials in children that were stopped prematurely, as well as the proportion of completed trials whose results were not reported.

"Hybrid closed-loop" systems for blood glucose control: another way of delivering intensive insulin therapy

"Hybrid closed-loop" systems for blood glucose control in type 1 diabetes appear to maintain blood glucose close to physiological levels slightly more of the time than a "conventional" insulin pump, in particular at night. However, they also appear to slightly increase the incidence of hyperglycaemic episodes, mainly through malfunctions.
Full article (4 pages) available for download by subscribers

Venlafaxine in the first trimester of pregnancy: possible risk of birth defects, especially cardiac malformations

Adverse Effects Venlafaxine is more dangerous than "selective" serotonin reuptake inhibitor antidepressants. It has been on Prescrire's list of drugs to avoid since 2014. As of 2023, various studies have shown that venlafaxine use during the first trimester of pregnancy carries a risk of birth defects, especially cardiac malformations.
Full article (2 pages) available for download by subscribers

Good sources

Editorial The most robust evidence of a treatment's efficacy comes from comparative trials, conducted in accordance with a rigorous methodology to ensure that the comparison was not biased. Yet few health professionals have both the time and experience required to analyse trials themselves and put their results into perspective.

Ivacaftor + tezacaftor + elexacaftor (Kaftrio°) in cystic fibrosis with at least one delta F508 mutation from 6 years of age

Marketing Authorisations Triple therapy with the CFTR modulators ivacaftor + tezacaftor + elexacaftor was initially authorised in the European Union for adults and adolescents who have cystic fibrosis with a delta F508 mutation on at least one of the CFTR alleles. It has also been authorised for use in children in the same situation, aged 6 years and older.
Full article (2 pages) available for download by subscribers

Drug-induced impairment of lactation

Adverse Effects There are numerous causes of insufficient maternal milk production. It is often due to insufficiently frequent suckling and/or failure to "empty" the breasts sufficiently, for example because of nipple disorders. Sometimes, however, drugs are to blame.
Full article (4 pages) available for download by subscribers

Proving a treatment's efficacy

Outlook What is the best way to demonstrate a treatment's efficacy? In other words, how do you establish a causal relationship between the treatment and a clinical improvement of sufficient value that it justifies the risk of experiencing the treatment's known, and as yet unknown, harms?

Full article (4 pages) available for free download.

Difelikefalin (Kapruvia°) in pruritus associated with chronic kidney disease

Marketing Authorisations Difelikefalin is the first drug to be authorised in the European Union for the treatment of moderate to severe pruritis associated with chronic kidney disease in patients on haemodialysis.
Full article (4 pages) available for download by subscribers

Prescrire's finances: 2022 annual report

Every year, Association Mieux Prescrire, the legal entity responsible for Prescrire's publications, publishes a summary of its annual financial report in the March issue of Prescrire and in the June issue of Prescrire International. The summary of its 2022 annual report is publicly available here.

Recombinant Beta variant covid-19 vaccine with adjuvant (Vidprevtyn Beta°), as a booster

COVID-19 The recombinant Beta variant covid-19 vaccine with AS03 adjuvant was authorised in the European Union in mid-November 2022, for use only as a booster in adults who have already received an mRNA or viral-vector vaccine.
Full article (2 pages) available for download by subscribers

A difficult choice

Editorial Corticosteroids have been used for a very long time, and a great deal is known about their adverse effect profile. In some chronic inflammatory diseases, other drugs with immunosuppressive effects are proposed, with the aim of reducing corticosteroid use. These drugs' adverse effects differ in part from those of corticosteroids, but some of them may not yet be known.

Anifrolumab (Saphnelo°) in systemic lupus erythematosus after failure of standard therapy

Marketing Authorisations Anifrolumab is a monoclonal antibody that inhibits receptors for type I interferons. This immunosuppressant has been authorised in the European Union as add-on therapy for patients with systemic lupus erythematosus in whom standard treatment has been insufficiently effective.
Full article (3 pages) available for download by subscribers

Dabigatran (Pradaxa°) for venous thrombosis in children and adolescents

Marketing Authorisations Dabigatran, an anticoagulant of the thrombin inhibitor class authorised for use in adults after venous thrombosis, a situation in which it does not represent a therapeutic advance, has now also been authorised for patients less than 18 years of age.
Full article (2 pages) available for download by subscribers

Janus kinase inhibitors: higher incidence of serious adverse effects and death than with TNF-alpha inhibitors

Adverse Effects The increased incidence of serious adverse effects associated with tofacitinib and baricitinib, and probably also the three other JAK inhibitors used in chronic inflammatory diseases, raises questions about the harm-benefit balance of drugs of this class.
Full article (1 page) available for download by subscribers

Dutasteride, finasteride: high-grade prostate cancer (continued)

Adverse Effects In the early 2010s, a trial of finasteride versus placebo in about 19 000 men with no clinical signs of prostate cancer found a decrease in the total number of diagnoses of prostate cancer in the finasteride group, but an increased incidence of particularly aggressive prostate cancer.
Full article (2 pages) available for download by subscribers

Order of magnitude

Editorial In many fields, such as aeronautical or mechanical engineering, accurate measurements and precise execution are essential. This is also true in some fields of medicine, such as pathology, where treatment decisions can hinge on the accuracy of a histological description or test result. However, in medicine in general and health care in particular, accurate measurements are not always available.

Prescrire's ratings of new drugs in 2022

Marketing Authorisations Only 11 of the 124 new marketing authorisations analysed and rated in our French edition in 2022 represented a notable therapeutic advance for patients.

Belimumab (Benlysta°) in lupus nephritis

Marketing Authorisations Belimumab, a monoclonal antibody directed against a protein called BLyS (B lymphocyte stimulator), was initially authorised in the European Union for subcutaneous or intravenous use in systemic lupus erythematosus. It has now also been authorised for use in active lupus nephritis.

Omicron variant BQ.1.1: nirmatrelvir + ritonavir retains activity, monoclonal antibodies do not

COVID-19 The Sars-CoV-2 circulating in France as of December 2022 is the BQ.1.1 sublineage of Omicron variant BA.5. To what degree does this affect the possible benefits of treatment with Sars-CoV-2-specific monoclonal antibodies or the combination of nirmatrelvir + ritonavir (Paxlovid°)? A few studies have provided some answers to this question.

Ibrutinib: increased risk of sudden death

Adverse Effects Data from clinical trials show a 5-fold greater risk of sudden or cardiac death with ibrutinib than with comparators.

The Drug Prescrire Awards for 2022: no "Pilule d'Or", one drug on the "Honours List". Details in the March issue of Prescrire International

None of the drugs examined by Prescrire in 2022 represented a major therapeutic advance worthy of a Pilule d'Or ("Golden Pill" Award). One drug made the Honours List, while one other was cited as Noteworthy.

Negligence

Editorial According to a World Health Organization (WHO) news release from 27 October 2022, almost 11 million people worldwide fell ill with tuberculosis in 2021, including about a million children. More than 1.5 million people died from tuberculosis.

Oral vitamin D supplementation: dangerous overdoses caused by errors

Adverse Effects Vitamin D overdose exposes patients to the risk of hypercalcaemia and hyperphosphataemia, and their sometimes serious or even fatal adverse effects, including: thirst, polyuria, anorexia, constipation, muscle weakness, fatigue, nausea and vomiting, confusion and renal disorders.

Full article (3 pages) available for download by subscribers

Empagliflozin (Jardiance°) in chronic heart failure

Marketing Authorisations Given the absence of any comparison with other heart-failure drugs, empagliflozin has not been shown to represent a therapeutic advance. In particular, when the left ventricular ejection fraction is reduced, there is no evidence to suggest that empagliflozin offers any advantages over dapagliflozin.
Full article (2 pages) available for download by subscribers

Winners and losers

Marketing Authorisations In the European Union, it has been possible since the mid-2000s for a drug's marketing authorisation to be conditional, i.e. granted on condition that the company subsequently provides data to justify full, standard marketing authorisation. The stated aim is commendable: hasten access to a drug in situations where no satisfactory options are available to patients and healthcare professionals.
Full article (1 page) available for download by subscribers

Building the evidence base

Editorial Healthcare decisions are based on the available evaluation data, also referred to as "evidence". This evidence base is constantly evolving, through a process of continuous construction and reconstruction. We can all play our part, in our own way, in building and improving the evidence base.

Semaglutide (Wegovy°) for excess body weight: nothing new

Marketing Authorisations While awaiting publication of the full, detailed results of the "Select" trial, it is best not to count on semaglutide to achieve durable weight loss, but to focus instead on a comprehensive non-pharmacological approach.
Full article (3 pages) available for download by subscribers

Icosapent ethyl (Vazkepa°) in cardiovascular prevention: not acceptable

Marketing Authorisations Despite trials including tens of thousands of patients, omega-3 fatty acids have not been shown to improve clinical outcomes in cardiovascular prevention. The evaluation data on icosapent ethyl, which is simply a source of the omega-3 fatty acid eicosapentaenoic acid, do not alter this conclusion.
Full article (3 pages) available for download by subscribers

Metformin during pregnancy: possible risk of malformations

Adverse Effects Metformin does not appear to be associated with a high risk of malformations, but the available data do not rule out the possibility that metformin exposure increases the risk of certain rare but serious malformations.

Full article (3 pages) available for download by subscribers

Drugs to avoid in the name of better patient care: 2023 update

DRUGS TO AVOID - 2023 UPDATE To make it easier to choose quality care, and to prevent disproportionate harm to patients, Prescrire has published its annual update of drugs to avoid. Learn more...
Full article (11 pages) available for free download

Universities challenge the impact factor

At the start of the 2020s, steps are being taken in some countries to improve the assessment of research.

Revolving door between the public and private sectors: conflict of interest

Editorial In Europe, as in the United States, senior public officials sometimes go on to occupy positions in the private, for-profit sector, and vice versa. The blurring of roles and conflicts of interest this situation engenders are detrimental to the public interest. There are many such examples in the health sector.

Relugolix + estradiol + norethisterone (Ryeqo°) in uterine fibroids: not acceptable

Marketing Authorisations The three-drug combination of relugolix + estradiol + norethisterone was mainly evaluated in two placebo-controlled trials. It markedly reduced menstrual bleeding in most women, but not fibroid volume, and no conclusive evidence of effects on other symptoms was obtained.
Full article (4 pages) available for download by subscribers

Setmelanotide (Imcivree°) in certain, very rare, genetic forms of obesity: possibly helpful

Marketing Authorisations Evaluation of setmelanotide in the very rare patients with obesity due to POMC, PCSK1 or LEPR mutations is only based on two non-comparative trials, in a total of 30 patients treated for one year. These trials suggest that daily subcutaneous injections of setmelanotide help patients feel less hungry, and consequently lose weight, especially those with POMC deficiency.
Full article (3 pages) available for download by subscribers

Trimebutine: too many cardiac risks

Adverse Effects In 2021, using data from 444 575 patients, a Korean team observed that the risk of QT interval prolongation linked to hydroxychloroquine was greater in patients who were also exposed to trimebutine.

Full article available for download by subscribers

Impending changes to European pharmaceutical regulations: part II

ADVANCING HEALTHCARE POLICY In order to prepare its new "Pharmaceutical Strategy for Europe", the European Commission organised several public consultations in advance. The present article reproduces extensive excerpts from a report published by the European Parliamentary Research Service, produced in connection with these consultations, which calls for the creation of a "European Medicines Infrastructure".

Full article (3 pages) available for free download

Dapivirine vaginal ring in the prevention of HIV

Marketing Authorisations Fragile data from a single clinical trial suggest that the dapivirine vaginal ring has at best partial efficacy in the prevention of HIV infection, with a considerable margin of uncertainty.

Full article (4 pages) available for download by subscribers.

Europe and medicines

Editorial The European Commission is due to propose changes to European pharmaceutical legislation in early 2023, in what has been presented as a major revision. No doubt the industry's lobby groups will attempt to shape the legislation in their favour. But civil society organisations will also have their say.

Opioids: endocrine disruptors

Adverse Effects Data from clinical trials, cohort studies and other sources show that opioids also have several endocrine effects, usually in the form of a hormone insufficiency, by acting on the hypothalamic-pituitary axis.

Full article (3 pages) available for download by subscribers.

Impending changes to European pharmaceutical regulations: part 1

ADVANCING HEALTHCARE POLICY In 2020, the European Commission announced its new "Pharmaceutical Strategy for Europe" for the coming years. The new legislation is due to be published in 2023.

Full article (3 pages) available for free download.

Nivolumab (Opdivo°) as adjuvant treatment for certain oesophageal cancers

Marketing Authorisations No proven increase in survival, as of mid-2022, in a double-blind randomised placebo-controlled trial in 794 patients. Longer time before relapse, but with adverse effects that are sometimes serious.

Full article (1 page) available for download by subscribers.

Bivalent mRNA covid-19 vaccines that also target the Omicron variant: more antibodies

Marketing Authorisations Four bivalent messenger RNA (mRNA) vaccines, based on the first Sars-CoV-2 strain isolated and a strain of the Omicron variant of this virus, have been authorised in the European Union. How do Prescrire's editors rate these vaccines?

Full article (2 pages) available for download by subscribers.

Risdiplam (Evrysdi°) in spinal muscular atrophy. Continue the evaluation

FEATURED REVIEW Risdiplam has been authorised in the European Union for use in patients aged 2 months or older with spinal muscular atrophy. How do Prescrire's editors rate this drug in this situation?
Full review (3 pages) available for download by subscribers.

A change of paradigm

Editorial It is time to extricate ourselves from the paradigm in which drugs are the mainstay of our response to health problems, and to embrace one in which they are just one option rather than an automatic reflex.

Liraglutide (Saxenda°) in obesity in adolescents: not acceptable

Liraglutide is authorised for use in patients with type 2 diabetes and in obese adults. Its marketing authorisation has now been extended to include obese adolescents.

Cannabidiol (Epidyolex°) in epilepsy associated with tuberous sclerosis complex

Cannabidiol, a substance present in cannabis, has antiepileptic properties. Having already been authorised in the European Union for children with certain severe forms of epilepsy, it has now also been authorised for use in patients aged 2 years and older who have epileptic seizures associated with tuberous sclerosis complex.

Messenger RNA covid-19 vaccines: an update on adverse effects

COVID-19 Two messenger RNA (mRNA) covid-19 vaccines, tozinameran (Comirnaty° from the pharmaceutical companies Pfizer and BioNTech) and elasomeran (Spikevax° from Moderna), have been marketed in the European Union since late 2020. What is known, as of mid-2022, about the adverse effects of these mRNA covid-19 vaccines?

Etifoxine: a dangerous drug still on the market

The European reassessment of etifoxine, a dangerous drug with no demonstrated efficacy, has only led to some modifications of the summary of product characteristics (SmPC) and the package leaflet.

The 2022 Prescrire Prize is awarded in Paris
to 6 healthcare-related books or projects

The recipients of the 2022 "Prix Prescrire" awards were announced in Paris on 6 October 2022, by the editors of the independent medical journal La Revue Prescrire. The prize recognises books, other works or initiatives of particular interest to the general public and/or healthcare professionals.

Viral vector covid-19 vaccines authorised in the European Union: a review of their adverse effects

FEATURED REVIEW The first-choice options for the prevention of covid-19 are the messenger RNA (mRNA) covid-19 vaccines, with the two viral vector vaccines, covid-19 vaccine ChAdOx1-S (Vaxzevria° from AstraZeneca) and covid-19 vaccine Ad26.COV2-S (Jcovden° from Janssen-Cilag), as second choices. What adverse effects are known to occur with these viral vector vaccines?
Full review (3 pages) available for download by subscribers.

In the October issue of Prescrire International: Trastuzumab deruxtecan (Enhertu°) in HER2-positive metastatic breast cancer

FREE DOWNLOAD Evaluation of trastuzumab deruxtecan (Enhertu°), authorised for treatment of some inoperable or metastatic breast cancers, was mainly based on one non-comparative trial, with a primary endpoint that is not necessarily objective.

Full text available for free download.

An African covid-19 vaccine, despite foot-dragging by drug companies

Editorial As part of a WHO technology-transfer initiative, the South African biotech company Afrigen succeeded in producing a small quantity of a copy of Moderna's covid-19 vaccine elasomeran (Spikevax°). Since then, Afrigen has been working on the development and large-scale production of formulations that would be cheaper and less heat-sensitive than the original vaccine, to facilitate its use in Africa.

Oral contraception: estetrol + drospirenone (Drovelis°), a combination to avoid

Yet another combined oral contraceptive has been marketed in Europe: a combination of estetrol and drospirenone (Drovelis°). But it is probably better to avoid the combination of an insufficiently evaluated oestrogen and a progestogen with worrying adverse effects.

Antibiotic resistance: a growing threat

Action is needed on various fronts to tackle microbial resistance, including reducing the use of antibiotics in intensive animal-rearing, rationalising their use in humans, and developing antibiotics with new mechanisms of action.

Oral use of injectable drugs: uncertain efficacy and known risks

Healthcare professionals sometimes administer an injectable form of a drug by mouth when no suitable oral liquid form exists. It is a risky and often ineffective practice. There is an old saying in France that if a substance can be injected it can also be swallowed, but despite its appeal, this idea is misleading and dangerous.

Mycophenolic acid and pregnancy: genotoxicity, malformations, spontaneous abortions

FEATURED REVIEW Mycophenolic acid is used as an immunosuppressant to prevent graft rejection after certain types of organ transplant. What is known as of mid-2022 about the possible harms to children of in-utero exposure to this drug?
Full review (4 pages) available for download by subscribers.

In the September issue of Prescrire International: late-onset neutropenia linked to rituximab (Mabthera° or other brands)

FREE DOWNLOAD Among 104 reports to French regional pharmacovigilance centres involving severe late-onset neutropenia linked to rituximab, the time to onset varied from 1.5 to 15 months after the last dose. These cases of neutropenia expose patients to a risk of serious infections.

Full text available for free download.

Moderate use of medicines

Editorial There are many reasons for moderate use of medicines. First and foremost, to reduce the risk of adverse effects and drug interactions. But also to use drugs for what they are: just one of several therapeutic options, not the answer to everything.

Imiquimod 3.75% cream (Zyclara°) in actinic keratosis

In Focus An imiquimod 3.75% cream came onto the French market in 2021, under the brand name Zyclara°. It has a lower dose strength than Aldara° (3.75% instead of 5%), and it is applied daily for two 14-day periods. What do Prescrire's editors make of this new product?

How long should one wait after stopping a drug before starting a pregnancy?

Some key principles to help answer this question without relying solely on the summary of product characteristics.

Prescrire's annual review of drug packaging: choose high-quality packaging for safer health care

A drug's packaging contributes greatly to the quality of care patients receive, to patients' safety, and to the safety of those around them. There were a few signs of progress in 2021, but packaging is still too often neglected by drug companies and regulators.

The European Implementing Regulation on Pharmacovigilance Activities

The proposed revision is a step towards greater independence from drug companies and better control of the quality and disclosure of data, but additional improvements are needed.

EMA's response to Prescrire's analysis of EMA's transparency policy over the last 10 years

The reply by the European Medicines Agency's Executive Director, in response to Prescrire's critique of the Agency's transparency policy, with comments added by Prescrire, appears in the September 2022 issue of Prescrire International.

Rivaroxaban (Xarelto°) for venous thromboembolism in children and adolescents

FEATURED REVIEW Rivaroxaban is the first oral factor Xa inhibitor to be granted marketing authorisation in the European Union for use in children and adolescents. In this situation, what benefit does rivaroxaban bring, compared to a heparin derivative or warfarin? What is its adverse effect profile in children and adolescents?
Full review (3 pages) available for download by subscribers.

Prescrire's analysis of EMA's transparency policy over the last 10 years: EMA's reply with Prescrire's comments

ADVANCING HEALTHCARE POLICY Prescrire sent a copy of its article "European Medicines Agency: transparency policy marred by too many failings" to Emer Cooke, Executive Director of the European Medicine Agency. Here is Emer Cooke's reply, with comments added by Prescrire.

In the July-August issue of Prescrire International: Indacaterol + glycopyrronium + mometasone (Enerzair Breezhaler°) in asthma

FREE DOWNLOAD How do Prescrire's editors rate this new fixed-dose combination? And what about the questions raised by a "connected drug" such as the Enerzair Breezhaler°, with its electronic sensor that can record and transmit various data?

Full text available for free download.

Covid-19: delays in other types of health care

Editorial Over 5 million deaths have been directly attributed to the covid-19 pandemic in 2020 and 2021. The estimated number of deaths doubles to quadruples when unrecorded cases and indirect deaths due to the impact of the pandemic on other healthcare services are taken into account.

Delays in access to EMA documents: the Agency confers with Prescrire

A video conference was held between the European Medicines Agency (EMA) and Prescrire to discuss the delays in dealing with Prescrire's requests for access to documents.

Intra-articular corticosteroids: risk of rapid destruction of the hip joint

Injection of corticosteroids into the hip joint is aimed at reducing pain and delaying the need for hip replacement. It is possible that, in some patients, these injections cause a rapid exacerbation of their condition.

Prescrire is taking action at the European level

Via its policy advocacy, Prescrire acts as a force for change in health policies, first and foremost in the interest of patients. Summaries of three such actions undertaken at the European level were published in Prescrire International's July-August issue.

Abnormal body odour: drugs can be responsible

Some drugs alter body odour through their own odour, or via their effects on sweat, breath odour, saliva, or the microflora of the skin or mucous membranes.

New! "2025 Free Special Edition", from the editors of Prescrire International

FREE SPECIAL EDITION Check out this selection of articles to introduce you to Prescrire International, a wholly independent monthly drug bulletin, written by and for healthcare professionals. Includes an array of articles from the past year on drugs and health policy in Europe. > Click here for your free copy

Nirmatrelvir + ritonavir (Paxlovid°) in covid-19, for certain patients at risk of developing severe disease

FEATURED REVIEW The combination of nirmatrelvir + ritonavir (Paxlovid°) is an oral antiviral treatment for adults with covid-19 who have had symptoms for 5 days at most and do not require oxygen therapy, but who have at least one risk factor for developing severe covid-19. How do Prescrire's editors rate this combination in this situation?
Full review (4 pages) available for download by subscribers.

In the June issue of Prescrire International. Hydroxycarbamide: interstitial lung disease

FREE DOWNLOAD Hydroxycarbamide, alias hydroxyurea, is a cytotoxic drug administered orally in some myeloproliferative syndromes, and to some patients with sickle cell disease to prevent acutely painful vaso-occlusive crises, acute chest syndrome and hospitalisation.

Full text available for free download.

Not that common

Editorial Independence. Transparency. Two words that are overused, especially in the field of health care. Prescrire takes transparency as far as publishing its financial statement every year. Which is not that common.

Prescrire's finances: 2021 annual report

Association Mieux Prescrire (AMP), the legal entity responsible for Prescrire's publications, is a non-profit organisation that makes its accounts public every year. The annual report for 2021 appears in the June issue of Prescrire International, and online here.

Messenger RNA covid-19 vaccines tozinameran (Comirnaty°) and elasomeran (Spikevax°) during pregnancy

in focusWhat main points should pregnant women be aware of in order to make informed decisions about covid-19 vaccination?

Peanut allergy: peanut-avoidant diet and access to adrenaline injector pens

For patients with peanut allergy, complete elimination of peanuts from the diet and access to adrenaline pens is a better option than oral desensitisation.

Strategic choices

Editors' Opinion Choosing certain endpoints in clinical trials can mask outcomes that really matter to patients. It is certainly not a strategy that ensures high-quality treatments that improve patient care.

Depression: possible increase in the risk of suicide with esketamine (Spravato°)

Clinical trials and pharmacovigilance data show a possible increase in the risk of suicide with esketamine (Spravato°), a drug authorised for use in "treatment-resistant" depression and "psychiatric emergencies".

"Preventing Overdiagnosis 2022": an international conference to be held in Calgary, 9-12 June

The not-for-profit group "Preventing Overdiagnosis", dedicated to "winding back the harms of too much medicine", will be holding its 2022 conference in Calgary, Canada.

Ozanimod (Zeposia°) in multiple sclerosis. As ineffective and probably as toxic as fingolimod

FEATURED REVIEW This immunosuppressant has been authorised in the European Union for use in adults with a relapsing-remitting form of multiple sclerosis. Is ozanimod more effective than an interferon beta at reducing the number of relapses and slowing the progression of disability? And what are its adverse effects?
Full review (3 pages) available for download by subscribers.

In the May issue of Prescrire International: Pertuzumab + trastuzumab (Phesgo°) by subcutaneous injection, in certain types of breast cancer

FREE DOWNLOAD A solution for subcutaneous injection containing a fixed-dose combination of these two anti-HER2 monoclonal antibodies has been authorised in the EU. How do Prescrire's editors rate this combination in its new form?

Full text available for free download.

The EMA is withholding too much information

Editorial Transparency is a requirement for better and safer patient care. There is no valid reason to hide information about clinical trials, their methodology or their results, or evaluation data obtained on drugs after their market introduction, particularly data on adverse effects.

European Medicines Agency: insufficient transparency

In Focus The EMA's failings on transparency warrant an official inquiry, so that European decision-makers can take remedial action.

Fostemsavir (Rukobia°) in multidrug-resistant HIV-1 infection

The initial treatment for patients with HIV-1 infection is based on a combination of antiretroviral drugs. Sometimes the virus is or becomes resistant to the various drug combinations that are available. How do Prescrire's editors rate fostemsavir (Rukobia°) in this situation?

Pharmacobezoars may prolong effects of overdose

Pharmacobezoars are a possibility to be kept in mind when, after intentional overdose with drugs taken in a solid form, symptoms of overdose persist or reappear after initial improvement.

Prescrire's Solidarity Support Programme: facilitating access to reliable and independent information around the world

Since 1993, Prescrire's Solidarity Support Programme has been raising funds from Prescrire subscribers, helping health professionals in countries with insufficient financial resources and those training to become healthcare professionals to obtain quality, independent information. The Programme has just published its annual report for 2021.

Cabotegravir (Vocabria°) and rilpivirine (Rekambys°) intramuscular injections in HIV infection

FEATURED REVIEW The standard treatment for patients with HIV infection is a combination of at least three antiretrovirals. An oral two-drug regimen is sometimes considered. How do Prescrire's editors rate this combination, administered by intramuscular injection?
Full review (2 pages) available for download by subscribers.

In the April issue of Prescrire International: Dupilumab (Dupixent°) in severe atopic eczema from 6 years of age

FREE DOWNLOAD Dupilumab is an immunosuppressant monoclonal antibody which was already authorised in the European Union for use in adults and adolescents with troublesome atopic eczema. How do Prescrire's editors rate this drug in younger children?

Full text available for free download.

Balancing act

Editorial Making healthcare decisions is a balancing act, sometimes a tricky one. When the data are insubstantial or non-existent, the greater the uncertainty and the trickier the balancing act.

The Innovative Medicines Initiative: a European public-private partnership that mostly benefits Big Pharma

IN FOCUSEurope's "Joint Technology Initiative on Innovative Medicines" (IMI) was created in 2007. The official objective was to improve the drug development process, so that the pharmaceutical sector could produce safer, more effective new drugs in the long term. How has the partnership measured up?
Full review (4 pages) available for download by subscribers.

Drugs in 2021: a brief review

Just 17 of the 108 new marketing authorisations analysed and rated in our French edition in 2021 represented a major or notable therapeutic advance for patients. How does this finding for 2021 compare with prior years?

Fentanyl: overdose and dependence with fast-acting forms

Fast-acting forms of fentanyl, a strong opioid analgesic, must be used with caution, patients must be thoroughly informed, and excessive doses must be avoided.

Isotretinoin: too many pregnancies still at risk

Despite a series of measures, unborn children are still being exposed to isotretinoin during pregnancy, with a risk of serious malformations and/or neuropsychiatric disorders.

Down with the "p value"! A move to democratise health information

NEWS FLASH French medical journal La Revue Prescrire has just revealed a new report from the Universal Medicines Agency (UMA) dated 1 April 2022, highlighting the arbitrary and intrensically fallacious character of statistical analysis. The Agency is creating a new pathway for evaluation of medicines, based on a "democratic" interpretation of clinical trial results. > Read more

• Down with the decline in vigilance! Mind your p's and q's

In today's ever more skewed world, it's more important than ever to use every tool at one's disposal to determine if a result is significant. Or just plain old fishy.

Watch the video of the webinar "Prescrire, A Critical Eye on New Drugs"

VIDEO How many new drugs offer an advantage and how many bring nothing new? Prescrire has been answering this key question since 1981. In a March 2022 webinar organised by Consilium Scientific, Pierre Chirac of Prescrire explained the reason for Prescrire's existence, the people behind it, its operations, its main achievements, and its limitations.

Ivacaftor + tezacaftor + elexacaftor (Kaftrio°) in cystic fibrosis with at least one F508del mutation: respiratory symptoms alleviated in the short term

FEATURED REVIEW Is this triple therapy more effective than dual therapy at reducing the incidence of pulmonary exacerbations and alleviating symptoms? Does it slow disease progression and extend survival? What adverse effects are associated with the addition of elexacaftor?
Full review (4 pages) available for download by subscribers.

In the March issue of Prescrire International: Revision of European pharmaceuticals legislation

FREE DOWNLOAD Prescrire has responded to a public consultation on a planned revision of Directive 2001/83 "on the Community code relating to medicinal products" and Regulation 726/2004 "laying down Community procedures for the authorisation and supervision of medicinal products (...) and establishing a European Medicines Agency".

Full text available for free download.

Rational deprescribing

Editorial The term "deprescribing" has been used more and more in recent years. But deprescribing, like prescribing, is not without risk.

The Prescrire Awards for 2021: two "Pilule d'Or" Awards, and 5 drugs on the "Honours List". Details in the March issue of Prescrire International

The

independent French medical journal Prescrire conferred two "Pilule d'Or" ("Golden Pill") Awards for 2021; 5 drugs made the "Honours List", and 2 drugs were deemed "Noteworthy". Details for the Drug and Information Awards, published in the March issue of Prescrire International, are available HERE.

Tramadol: achieving successful withdrawal after prolonged use

Tramadol, an opioid analgesic authorised for relief of moderate to severe pain, carries a risk of dependence. Discontinuation is sometimes difficult and can require strong patient motivation as well as long-term medical support.

Benzodiazepines: risk of persistent use even after brief treatment

Occasional benzodiazepine use is often followed by repeated use, and there is a risk of addiction. When a benzodiazepine is justified, it is important to plan its withdrawal, together with the patient, as soon as treatment starts.

Prescrire publishes its annual update of drugs to avoid, in the name of better patient care

DRUGS TO AVOID - 2022 UPDATE For the tenth consecutive year, independent French medical journal Prescrire has published its annual update of drugs to avoid. The goal is to make it easier to choose high-quality care, and to prevent disproportionate harm to patients

Myocarditis linked to the covid-19 messenger RNA vaccines tozinameran (Comirnaty°) and elasomeran (Spikevax°): an update

FEATURED REVIEW A number of peer-reviewed articles and drug regulatory agency reports have been published around the world about cases of myocarditis attributed to the covid-19 messenger RNA vaccines tozinameran (Comirnaty°) and elasomeran (Spikevax°). What is known about the incidence, severity and risk factors for this adverse effect?
Full review (2 pages) available for download by subscribers.

In the February issue of Prescrire International: Rituximab (Mabthera° or other brands) in certain non-Hodgkin lymphomas in children

FREE DOWNLOAD In the "Marketing Authorisations" section of the February issue: what do Prescrire's editors make of the data regarding this new indication for rituximab?

Full text available for free download.

Covid-19 vaccines: good for business too

Editorial The speed with which effective vaccines were developed to combat the covid-19 pandemic was astonishing. And the speed with which certain drug companies have reaped enormous profits has been equally spectacular.

Nasal naloxone (Nyxoid°): effective in opioid overdoses

A new naloxone-containing nasal spray (Nyxoid°) has been authorised in the European Union for emergency use in medical and non-medical settings in adults and adolescents aged 14 years and over. How do Prescrire's editors rate this product in its new form?

Eosinophilic oesophagitis: the advantages of orodispersible budesonide (Jorveza°)

Orodispersible tablets of budesonide are being proposed for the treatment of eosinophilic oesophagitis, an immune-mediated disease. Budesonide is a corticosteroid already used in other forms and in other settings. The orodispersible form is better suited to oesophageal disease, with demonstrated efficacy against symptoms.

Pneumococcal vaccine: choose on the basis of the child's age

There have been reports in France of infants receiving unconjugated pneumococcal polysaccharide vaccine (Pneumovax°), which is ineffective at this age, instead of the pneumococcal conjugate vaccine (Prevenar°), as a result of prescribing or dispensing errors.

A critical eye

Editorial Welcome to the new, redesigned Prescrire International: a "critical eye" on drugs in Europe, with patients' interests front and centre.

Crizanlizumab (Adakveo°) to prevent vaso-occlusive crises in sickle-cell disease: No proven clinical advantages

FEATURED REVIEW Is crizanlizumab more effective than hydroxycarbamide for patients with sickle-cell disease? Does it prevent vaso-occlusive crises and their serious complications when hydroxycarbamide is not sufficiently effective or cannot be used? What is its adverse effect profile?
Full review (5 pages) available for download by subscribers.

In the January issue of Prescrire International: adverse effects of lamotrigine and biotin

FREE DOWNLOAD In our sample page from this month's issue, cardiac arrhythmias with lamotrigine, and biotin supplements' interference with laboratory tests.

Full text available for free download.

Dravet syndrome: fenfluramine (Fintepla°) for children is unacceptable

Giving fenfluramine to children with Dravet syndrome (a rare and severe form of epilepsy), including those whose seizures remain frequent despite optimised treatment, increases the incidence of the most serious seizures and exposes them to a risk of serious cardiovascular adverse effects.

Vitamin D drops for infants: mistakes to avoid

Errors and accidents are frequent with vitamin D supplied in dropper bottles. These include handling by children, eye exposure and, above all, overdose due to a mistake or related to a defective dropper bottle.

Alzheimer's: yet another unwelcome drug

Despite aducanumab's lack of demonstrated efficacy in Alzheimer's disease, the scene is set to raise the hopes of patients and those close to them, and above all to promote the interests of the company and its shareholders.

Dapagliflozin (Forxiga°) and chronic heart failure

FEATURED REVIEW An alternative to the sacubitril + valsartan combination, with the serious adverse effects common to all gliflozins.
Full review (3 pages) available for download by subscribers.

In the December issue of Prescrire International - Teriparatide (Forsteo° and other brands) in pen injectors or cartridges: multidose formulations which must not be drawn into a syringe

FREE DOWNLOAD Drawing the contents of a cartridge or prefilled pen into a syringe carries a risk of dosing errors.

Full text available for free download.

Full value

Editorial Packaging is a key determinant of a medicinal product's quality. It is high time that pharmaceutical companies and drug regulatory agencies appreciated the full value of high-quality drug packaging.

The newly redesigned Prescrire International, from January 2022!

COMING SOON From January 2022, the new, redesigned Prescrire International casts a critical eye on new drugs authorised in Europe. Don't miss out!

Hypoglycaemia with loss of consciousness in insulin-treated patients: a treatment that is easier to administer

When a patient with insulin-treated diabetes has lost consciousness due to hypoglycaemia, glucagon is the drug of choice. It is now available as a nasal spray (Baqsimi°), making it easier for the patient’s family or friends to manage severe hypoglycaemia.

Haemorrhaging after childbirth: medicines are sometimes responsible

Towards the end of pregnancy, the medicines the woman is taking, including serotonergic antidepressants (SSRIs and SNRIs), should be reviewed and sometimes adjusted, because some drugs can cause or worsen potentially fatal haemorrhages.

France's Mediator° trial reveals a cosy relationship between representatives of the French drug regulatory agency and an influential company

The trial revealed how representatives of the agency, external experts charged with drug evaluation, and the company were constantly trying to come to a consensus, leading to a delay in the decision to withdraw Mediator° from the market.
> Read more in our special section "Mediator° - the criminal trial"

Known adverse effects of messenger RNA covid-19 vaccines
as of mid-2021

FEATURED REVIEW With several hundred million people worldwide now vaccinated with an mRNA vaccine, surveillance conducted by various pharmacovigilance teams has identified a few signals of very rare adverse effects, notably pericarditis and myocarditis.
Full review (2 pages) available for download by subscribers.

In the November issue of Prescrire International: adverse effects of growth hormone and of thiazide diuretics

FREE DOWNLOAD In the "Adverse effects" section this month, Prescrire reports on the cardiovascular effects of growth hormone, and on ocular adverse effects of thiazide diuretics.

Full text available for free download.

Words and numbers

Editorial Evidence-based medicine is more than just numbers reported in randomised trials or meta-analyses. In some cases, the best evidence is to be found in qualitative data.

Asthma and COPD: don't confuse the brand name of the drug with the brand name of the inhaler

Some drugs for asthma or chronic obstructive pulmonary disease (COPD) are supplied with an inhaler device which has its own brand name. It is important to distinguish clearly between the name of the drug and the name of the inhaler.

Public health: why so many private consulting firms?

In France, private consulting firms have been called upon to play a role in public health, an area in which they have hardly distinguished themselves.

Medical devices that resemble medicines: some hope for improvement but continued scrutiny is needed

The new European regulation will perhaps result in some progress in relation to medical devices which resemble medicines. All will depend on how diligently it is applied.

Covid-19 vaccine booster dose: great uncertainty over its value in the general population

COVID-19 In the November edition of Prescrire International: what do the data indicate regarding the value of a booster dose for the general population? And what are the implications for the prevention of symptomatic covid-19?

The 2021 "Prescrire Prize" is awarded
to 4 books about health and healthcare

The recipients of the 2021 "Prix Prescrire" book awards were announced in Paris on 7 October 2021. The prize is awarded to books or other works of particular interest to the general public and/or healthcare professionals.

Bulevirtide (Hepcludex°) and chronic hepatitis D: no evidence of efficacy based on clinical endpoints

FEATURED REVIEW Bulevirtide (Hepcludex°) is the first antiviral drug authorised in the European Union for adults with chronic hepatitis D. In this situation, does bulevirtide reduce the incidence and severity of hepatic complications? Does it reduce HDV transmission? And what are its adverse effects?
Full review (3 pages) available for download by subscribers.

In the October issue of Prescrire International - Multidrug-resistant pulmonary tuberculosis and delamanid: no demonstrated clinical benefit

FREE DOWNLOAD It is helpful to have an antibiotic available which is active against multidrug-resistant mycobacteria. However, as of mid-2021, there is no demonstrated clinical benefit from addition of delamanid to an optimised multiple drug treatment regimen.

Full text available for free download.

Covid-19 vaccines: glaring inequality

Editorial It was estimated in late May 2021 that only 0.3% of the vaccines against covid-19 administered worldwide had been given in the poorest 29 countries. Western leaders are being called upon to do the right thing: a historic opportunity that must be seized.

Oral tramadol: children still being exposed to the risk of overdose

A concentrated solution of oral tramadol carries a risk of significant overdose through its error-prone dropper.

Titanium dioxide: is it carcinogenic in humans?

Present in food products, drugs, dietary supplements and cosmetics, titanium dioxide is a possible carcinogen, which should be avoided where possible.

Supplementary protection certificates: highly profitable for drug companies

A European scheme enables pharmaceutical companies to prolong their market monopoly, sometimes unjustifiably, to the detriment of social welfare systems.

The Sars-CoV-2 Delta variant: how effective are covid-19 vaccines against this strain?

COVID-19 In the October edition of Prescrire International, a look at the data available as of mid-2021 regarding the efficacy of covid-19 vaccines against the Delta variant.

Viral vector covid-19 vaccine ChAdOx1-S (Vaxzevria°) and covid-19. Efficacy in the short term, but a risk of rare, sometimes fatal, thrombosis

FEATURED REVIEW Following two mRNA vaccines, a viral vector vaccine, the covid-19 vaccine ChAdOx1-S (Vaxzevria°, AstraZeneca), has been authorised in the European Union. Like the two mRNA vaccines, this vaccine triggers an immune response against the S glycoprotein of Sars-CoV-2.
Full review (3 pages) available for download by subscribers.

In the September issue of Prescrire International - Psoriasis and ixekizumab: turn first to standard systemic treatments

FREE DOWNLOAD There is no strong evidence that ixekizumab has greater efficacy than methotrexate in patients with psoriasis. In addition, its adverse effects are less well established than those of standard treatments, particularly in the long term.

Full text available for free download.

Preventable deaths

Editorial A number of high-profile court cases have brought attention to thousands of victims made sick by their medication. It is within our grasp to prevent many patients from becoming victims, without waiting for scandals to erupt, by being cautious and attentive: attentive, first and foremost, to doing no harm.

Drug-induced sudden cardiac death and long QT syndrome

Many drugs directly increase the QT interval on the electrocardiogram, a disorder of electrical conduction associated with a risk of sometimes fatal cardiac disorders.

Stopping antidepressant therapy: plan tapered withdrawal

When stopping antidepressant therapy, reducing the dose stepwise over a period of more than 4 weeks helps to limit withdrawal symptoms.

Prescrire's annual review: drug packaging in 2020

Drug packaging is a key determinant of drug quality and is sometimes the deciding factor when choosing between treatments, in the interests of safety. It is still too often neglected by drug companies and regulators.

Trabectedin (Yondelis°): more dangerous than beneficial in ovarian cancer, yet the EMA maintains its position

Outlook The European Medicines Agency chose not to take into account data showing the significant toxicity of trabectedin and the lack of a tangible clinical benefit for patients. It is up to healthcare professionals to avoid exposing patients to this drug, which is more dangerous than beneficial.

Low-dose methotrexate: 2-year follow-up of adverse events

FEATURED REVIEW Low-dose methotrexate is a useful first-line treatment in a range of autoimmune diseases such as rheumatoid arthritis. A 2-year follow-up of several thousand patients provides new estimates of the frequency of adverse events.
Full review (2 pages) available for download by subscribers.

In the July-August issue of Prescrire International: fusidic acid + betamethasone valerate cream (Dermafusone°) and infected atopic eczema

FREE DOWNLOAD Atopic eczema is sometimes complicated by infection, most often caused by Staphylococcus aureus ("golden staph"), with the development of pustules and crusting. How do Prescrire's editors rate fusidic acid + betamethasone valerate cream in this situation?

Full text available for free download.

Show your face!

Editorial Are there any amphetamine derivatives still on the market? Yes, and healthcare professionals would do well to be able to spot them in order to anticipate their effects, in particular their adverse effects, and especially their cardiovascular adverse effects.

Human papillomavirus vaccine (Gardasil 9°): useful in young men too

The 9-valent human papillomavirus vaccine (Gardasil 9°) probably has a positive harm-benefit balance in the men who are the most at risk of developing papillomavirus-related cancer.

Proton pump inhibitors: avoid unjustified risks, and know how to "deprescribe"

It is better to be aware of the harms of prolonged use of proton pump inhibitors (drugs for gastrointestinal disorders), and to avoid prescribing or advising these drugs too readily.

Food supplements: too readily authorised and sometimes dangerous

Several factors contribute to a major ongoing confusion between food supplements and medicinal products. Large numbers of safety signals increasingly indicate the need for caution, whereas the benefit of taking food supplements remains uncertain.

Oral semaglutide (Rybelsus°): more uncertainty than with subcutaneous liraglutide

FEATURED REVIEW Semaglutide was first authorised in the European Union as a solution for weekly subcutaneous injections. It was authorised more recently in oral tablet form. How do Prescrire's editors rate this new product?
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International: Non-metastatic, castration-resistant prostate cancer

FREE DOWNLOAD Survival extended with the addition of apalutamide or enzalutamide.

Full text available for free download.

Covid-19 drugs and vaccines: big money and winning alliances

Editorial The market for covid-19 drugs and vaccines is huge, involving billions of patients, with tens of billions of dollars potentially up for grabs. Business as usual? Not quite.

Iodine during pregnancy: supplementation should not be systematic

Iodine-containing food supplements have no proven benefits for pregnant women, and can be dangerous for the unborn child.

Oral cancer drugs: care provided in community pharmacies

Community pharmacists in France can offer, and claim payment for, structured pharmaceutical care for the growing number of patients taking oral cancer drugs.

Memantine (Ebixa° and other brands): perception disorders

Memantine is a drug with psychotropic actions, misuse of which can become problematic, leading, in particular, to dissociative disorders which are not always effects being sought by the user.

Pre-exposure prophylaxis for HIV (PrEP): reduction in risk of infection confirmed

For patients at high risk of infection by the HIV virus, evaluation has confirmed the efficacy of PrEP using a combination of emtricitabine + tenofovir disoproxil (Truvada° and other brands).

Prescrire: independence and transparency, in the name of better patient care

The independent French medical journal Prescrire is produced by healthcare professionals who strive to protect medical information and continuing education from the contradictory influences at play in the medico-pharmaceutical arena.

Waste in covid-19 clinical trials

Outlook The covid-19 pandemic has given rise to a large number of clinical trials evaluating a wide range of therapeutic avenues, but not all are worthwhile.

"Cutting the Cord: Curtailing Commercial Influence on Healthcare" a conference to be held online, 16-18 June 2021

Organised by the US-based non-profit group PharmedOut, the conference will address commercial influence on healthcare, focussing on how its damaging effects can be mitigated.

France's Mediator° trial: Servier and the French drug regulatory agency convicted and sentenced

A Paris court ruled that the company Servier and its former second-in-command were guilty of "aggravated deception with endangerment to life" and "involuntary bodily harm and manslaughter" for having concealed the true properties of Mediator° (benfluorex). > Read more in our special section "Mediator° - the criminal trial"

Rituximab (Mabthera° or other brands) in pemphigus vulgaris: more patients in remission than with other immunosuppressants, lower exposure to corticosteroids, but a risk of cancer

FEATURED REVIEW Rituximab was already authorised in the European Union for various inflammatory diseases and various types of cancer. It has now also been authorised for use in moderate to severe pemphigus vulgaris, as add-on therapy with a tapering course of corticosteroid treatment.
Full review (5 pages) available for download by subscribers.

In the May issue of Prescrire International: Ciclosporin eye drops (Verkazia°) in severe vernal keratoconjunctivitis

FREE DOWNLOAD Eye drops containing ciclosporin at a concentration of 1 mg/ml (Verkazia°) have been authorised in the European Union for severe vernal keratoconjunctivitis in children from 4 years of age and in adolescents. How do Prescrire's editors rate this drug?

Full text available for free download.

Orphan drugs: amendment needed

Editorial The European orphan drug regulation needs to be amended, to ensure that it better serves patients' interests, and that the public resources invested benefit public health rather than private interests.

Medical cannabis: an experimental programme in France in 2021

The medical use of Cannabis sativa L., also known as hemp or cannabis, appears to be an option in the treatment of certain types of pain, despite its limited evaluation.

Baclofen: at moderate doses, an option for some alcohol-dependent patients

In addition to medical support, baclofen, at moderate doses of around 30 mg per day, is an option of limited usefulness.

Beware of "spin" in clinical trials

"Spin doctors" are not doctors in the medical sense, but rather public relations specialists whose job it is to enhance the image of an entity or individual. "Spin" however, in the sense of massaged facts, exists in medicine, where it obstructs the reliable evaluation of new drugs.

Larotrectinib (Vitrakvi°) and cancers with an NTRK gene fusion. Grossly inadequate evaluation as of early 2021

FEATURED REVIEW Larotrectinib (Vitrakvi°) is the first drug to have been authorised in the European Union for adults and children with a tumour that harbours an NTRK gene fusion. Is this "targeted therapy" on target? What does its authorisation tell us about the evaluation process?
Full review (5 pages) available for download by subscribers.

In the April issue of Prescrire International - Hydrochlorothiazide in hypertension: an acceptable first choice

FREE DOWNLOAD In countries where it is available, chlorthalidone is the first-choice thiazide diuretic. In France, where there is no available medicinal product containing chlorthalidone alone, the first-line thiazide diuretic is hydrochlorothiazide. How do these two drugs compare?

Full text available for free download.

40 years: life goes on, so does Prescrire

Editorial The women and men who "make" and "are" Prescrire share strong values and work together to support a unique multidisciplinary movement for quality healthcare, launched 40 years ago.

Drugs in 2020: a brief review

Just nine of the 109 new drugs, combinations, drug strengths, pharmaceutical forms or indictions analysed and rated in our French edition in 2020 constituted a notable therapeutic advance.

Valproic acid: probable endocrine disruptor

Some of the adverse effects of valproic acid are linked to disruption of the human body's hormone systems. Children, especially those exposed in utero, and adolescents are particularly sensitive to effects of this type.

Nasal decongestants withdrawn from the pan-European market

NEWS FLASH French medical journal La Revue Prescrire has just announced the decision by the Pan-European Medicines Agency (PEMA) to withdraw nasal decongestants from the market, effective 1 April 2021, throughout all 50 countries of the European continent.

• Safety signals: loss of sense of smell = danger

As the unending wave of medical information hits a fever pitch, it's more important then ever to remember to follow one's nose.

Covid-19 vaccine Ad26.CoV2S (by Janssen): as with the other covid-19 vaccines, effective in the short term but unknowns remain

NEWS UPDATE Covid-19 vaccine Ad26.CoV2S, marketed by the pharmaceutical company Janssen (part of the Johnson & Johnson group), was authorised in the European Union on 11 March 2021. What are the main data available as of mid-March 2021 from clinical trials of covid-19 vaccine Ad26.CoV2S?

The AstraZeneca covid-19 vaccine: British epidemiological data on the vaccination of older adults, and reassuring pharmacovigilance data

NEWS UPDATE ChAdOx1-S, the covid-19 vaccine marketed by the pharmaceutical company AstraZeneca, was authorised on the basis of comparative clinical trials conducted in 2020, from which it was not possible to evaluate the vaccine’s efficacy in older adults. As of March 2021, results available from two epidemiological studies conducted in the UK by public health agencies provide useful information about the vaccine’s efficacy during the first weeks following mass vaccination of older adults. At a time when 9.7 million first doses of this vaccine have been administered in the UK, no particular safety signals have been identified through British pharmacovigilance reporting.

Messenger RNA covid-19 vaccines: Prescrire's in-depth analysis as of end February 2021

COVID-19

The available clinical trial data have led the editors of independent French medical journal Prescrire to assign these vaccines the seldom-granted rating "A Real Advance".

Covid-19: a recap of treatment options. From Prescrire's comprehensive year-end review

FEATURED REVIEW Very large amounts of data about covid-19 were published over the past year. As they became available, Prescrire sorted through to determine just which data were useful for the treatment and prevention of the disease.
Full review (3 pages) available for download by subscribers.

In the March issue of Prescrire International: polatuzumab vedotin (Polivy°) and large B-cell lymphoma

FREE DOWNLOADPolatuzumab vedotin has been granted conditional European marketing authorisation for certain patients with relapsed or refractory diffuse large B-cell lymphoma. How do Prescrire's editors rate this option?

Full text available for free download.

Doing one's job

EDITORIALThe entire health system should be able to count on pharmaceutical companies to do their job, no more, no less. When the roles within the system become blurred, the quality of health care and patients' freedom to choose according to their needs both suffer.

Annual Prescrire Awards for 2020: 3 winning drugs, including the first "Pilule d'Or" in 6 years

The independent French medical journal Prescrire has published its annual Awards for drugs, drug packaging and information provided by drug companies in 2020. Two drugs made the "Honours List", and Prescrire's "Pilule d'Or" (Golden Pill) was awarded for the first time in 6 years.

Atopic eczema: avoid tacrolimus (Protopic° and other brands) and pimecrolimus (Elidel°)

In addition to avoiding factors causing skin irritation, the first-line treatment of atopic eczema is still based on application of an emollient and a topical corticosteroid.

Dry eye: sometimes drug-induced

The daily lives of many patients are affected by discomfort and visual disturbances, or even ocular lesions, associated with dry eye syndrome. Drugs are sometimes to blame.

Comparative trials: an ethical issue

Mounting evidence that hydroxychloroquine (Plaquenil°) lacks the efficacy expected in covid-19 has shown the medical and ethical risks of using drugs on the basis of inadequate evidence.

Prescrire’s response to the European Commission consultation on a "European Health Emergency Preparedness and Response Authority"

ADVANCING HEALTHCARE POLICY The Covid-19 pandemic has illustrated the need for enhanced EU action and coordination in response to cross-border health threats. In its response to the public consultation, Prescrire calls for: an independent, public-driven agency with clear public health missions; effective governance process and structure; public funding, with conditions to safeguard affordability, accessibility, availability and transparency.

Covid-19 and ivermectin: many trials, few results, no proven efficacy

NEWS UPDATE The antiparasitic drug ivermectin has been shown to have in vitro activity against Sars-CoV-2. What are the main results available in early February 2021 from comparative clinical trials of ivermectin in the treatment and prevention of covid-19?

The ChAdOx1 nCoV-19 covid-19 vaccine from AstraZeneca: great uncertainty over its efficacy

NEWS UPDATE Unlike the first two covid-19 vaccines authorised in Europe, which are messenger RNA vaccines, the covid19 vaccine ChAdOx1 nCoV-19, developed by the University of Oxford and the pharmaceutical company AstraZeneca, is a "viral vector" vaccine. What are the main data available in late January 2021 from the clinical trials of this new vaccine?

Prescrire publishes its annual update of drugs to avoid, in the name of better patient care

DRUGS TO AVOID - 2021 UPDATE For the ninth consecutive year, independent French medical journal Prescrire has published its annual update of drugs to avoid. The goal is to make it easier to choose high-quality care, and to prevent disproportionate harm to patients

Ebola vaccine rVSV-Zebov (Ervebo°) in an outbreak of Ebola virus disease. Major reduction in incidence among those at risk for this often-fatal infection

FEATURED REVIEW Ebola virus disease is a contagious and often fatal infection for which there was no vaccine or cure. According to two clinical trials, the live attenuated vaccine, Ebola vaccine rVSV-Zebov, confers high levels of protection to people who come into contact with infected patients.
Full review (5 pages) available for download by subscribers.

In the February issue of Prescrire International: Liposomal forms of drugs

FREE DOWNLOAD Healthcare professionals must take great care at every stage of the medication-use process when dealing with drugs that are available in liposomal and non-liposomal forms.

Full text available for free download.

Like any other drug?

EDITORIALAs with any other drug, the data available for the analysis of a vaccine's adverse effects are often less robust than those available for analysis of its efficacy. When all factors are taken into account, a vaccine sometimes clearly represents a therapeutic advance

Pregabalin (Lyrica° and other brands): abuse and dependence on the increase

Given the increase in cases of pregabalin abuse and dependence, the need for prescription should be kept under regular review, as well as any potentially dangerous combinations with other drugs.

Smoking cessation induces toxic dose levels of certain drugs

Toxic dose levels (alias overdose) of certain drugs have been observed a few weeks after the patient stopped smoking. Some had serious consequences, especially those involving a drug with a narrow therapeutic index.

The covid-19 messenger RNA vaccine from Moderna: as with the tozinameran vaccine (Comirnaty°, Pfizer/BioNTech), limited data and unanswered questions

NEWS UPDATE As of early January 2021, the covid-19 vaccine mRNA-1273 Sars-CoV-2, from the pharmaceutical company Moderna, is expected to be approved for use in the European Union. In France, this vaccine is to be offered first to elderly residents of nursing homes and similar facilities, and to certain health professionals. What are the main evaluation data obtained with this vaccine in these populations?

SSRI antidepressants and pregnancy: long-term neuropsychiatric disorders in exposed children?

FEATURED REVIEW Data available in 2017 suggested that in utero exposure to SSRI antidepressants increases the risk of autism. Do we have a clearer idea in 2020 of the long-term neuropsychiatric harms to the unborn child posed by the use of SSRI antidepressants during pregnancy?
Full review (3 pages) available for download by subscribers.

In the January issue of Prescrire International: Dasatinib (Sprycel° and other brands) in children with acute lymphoblastic leukaemia

FREE DOWNLOAD Dasatinib has been granted marketing authorisation in the European Union as first-line therapy added to chemotherapy for children with Philadelphia chromosome-positive acute lymphoblastic leukaemia.

Full text available for free download.

A two-step approach

EDITORIAL In the midst of the covid-19 crisis, Prescrire is fulfilling its mission via a two-step approach. Rapidly sharing key information, distinguishing fact from hypothesis and opinion. Then helping healthcare professionals to make rational choices, based on documented evidence rather than wishful thinking. Taking care not to confuse urgent action with undue haste.

Treatment-resistant depression: avoid esketamine (Spravato°)

Esketamine nasal spray (Spravato°) has been authorised for use in so-called "treatment-resistant" depression. Its efficacy is uncertain, and its harm-benefit balance is unfavourable due to serious adverse effects including neuropsychiatric and cardiac disorders.

Adverse effects of cancer drugs: often downplayed in articles reporting the results of clinical trials

The adverse effects that occurred during clinical trials are often omitted in articles, or described using subjective terms.

The covid-19 messenger RNA vaccine tozinameran (Comirnaty°, from Pfizer and BioNTech) in elderly patients: limited data, many uncertainties

NEWS UPDATE The vaccination campaign against the covid-19 epidemic is launching in late December 2020. The first populations to whom the French authorities have chosen to offer this covid-19 messenger RNA vaccine (marketed by the pharmaceutical companies Pfizer and BioNTech) are nursing home residents and certain health professionals who work in these facilities. What are the main data from the clinical evaluation of this vaccine in this population?

Covid-19 and vitamin D: too uncertain

NEWS UPDATE Interest has been expressed in using vitamin D in the prevention of Sars-CoV-2 infection or the treatment of covid-19. What evaluation data available as of late 2020 support this hypothesis?

Fexinidazole (Fexinidazole Winthrop°) and sleeping sickness caused by Trypanosoma brucei gambiense

FEATURED REVIEW Human African trypanosomiasis (or sleeping sickness) is endemic in many countries in sub-Saharan Africa. Is fexinidazole more effective than the standard treatments for sleeping sickness due to T. brucei gambiense? Does it have fewer adverse effects? Is it easier to use?
Full review (5 pages) available for download by subscribers.

An exemplary initiative

EDITORIALA successful collaboration between the Drugs for Neglected Diseases initiative (DNDi) and several other entities has shown that it is possible to develop drugs that satisfy a genuine need, with the sole aim of providing a therapeutic advance, without the promise of exclusive market access or huge profits.

In the December issue of Prescrire International: Betibeglogene autotemcel (Zynteglo°) in certain forms of severe beta thalassaemia

FREE DOWNLOAD Despite the uncertainties, an option for achieving transfusion independence in the absence of a compatible donor.

Full text available for free download.

Updated review of "Drugs to avoid, in the name of better patient care" is published by independent French journal Prescrire

The independent French medical journal Prescrire has published its annual review of "Drugs to avoid", identifying drugs that are clearly more harmful than beneficial. The full report will be published in English in the February 2020 issue of Prescrire International.

Depression: cardiac risks with citalopram (Seropram° and other brands), even greater if combined with omeprazole (Mopral° and other brands)

Citalopram (Seropram° and other brands), an antidepressant, carries a risk of cardiac rhythm disorders and sudden death, all the more so when combined with omeprazole (Mopral° and other brands), which is often used for gastric reflux and peptic ulcers.

Drug research: public funding, private profits

Drug companies receive many direct and indirect forms of public aid for pharmaceutical research, but the allocation of this aid lacks transparency, and recipients are not required to market the drugs concerned at affordable prices.

Mediator°: all wrong from the very start

In June 2020, at the end of France's Mediator° trial, the two prosecutors concluded that all the defendants were guilty of the offences with which they were charged. The judges' ruling is expected for 2021.

Evaluation of covid-19 vaccines: the questions to ask

NEWS UPDATE November 2020 has seen a flurry of press releases announcing effective, and apparently relatively safe, vaccines against covid-19. However, as no detailed results have been released, it is impossible to assess the quality and relevance of these claims. When we finally have more than headlines to go on, what questions will need to be asked about these clinical trials? The answers will help determine the usefulness of these vaccines and define the vaccination strategy, taking account of the interests of vaccinees and society as a whole.

Doxylamine during pregnancy: minimise dose and duration, due to possible link with malformations

FEATURED REVIEW Prescrire's analyses have for many years found doxylamine to be the first-choice antiemetic drug in early pregnancy, when non-pharmacological measures fail. A recent study suggests an increased risk of major birth defects. Does this finding affect doxylamine's harm-benefit balance and its place as the first-choice drug for relieving nausea and vomiting during pregnancy?
Full review (3 pages) available for download by subscribers.

In the November issue of Prescrire International: Dupilumab (Dupixent°) and nasal polyps

FREE DOWNLOAD Dupilumab (Dupixent°) has been authorised in the European Union for adults with very troublesome nasal polyposis. How do Prescrire's editors rate dupilumab in this situation?

Full text available for free download.

Memory can save lives

EDITORIALIn the field of pharmaceuticals, novelty is not always what it seems. It is often useful to remember the chemical relationships between substances, in order to predict certain beneficial or adverse effects.

Dapagliflozin (Forxiga°): no place in type 1 diabetes

Dapagliflozin (Forxiga°) has no demonstrated efficacy with regard to the clinical complications of type 1 diabetes and it carries a risk of sometimes serious adverse effects.

Clinical trials of drugs: the various types of placebo used

In certain situations, the best way of telling the extent to which a treatment's apparent effects are due to the natural history of the disease or the treatment itself is to compare it with a placebo.

The 2020 "Prescrire Prize" is awarded in Paris to
3 noteworthy books about health and healthcare

The recipients of the 2020 "Prescrire Prize" book awards were announced on 1 October 2020. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Apixaban, edoxaban, rivaroxaban: situations with a high risk of bleeding or thrombosis

FEATURED REVIEW When using xabans, it is essential to take into account the situations that increase the risk of bleeding or thrombosis, and to monitor the patient for any change in these risks, such as new comorbidities, new drugs, or discontinued drugs.
Full review (4 pages) available for download by subscribers.

In the October issue of Prescrire International: A public awareness campaign which mainly benefits companies

FREE DOWNLOAD The pharmaceutical company Abbvie, which markets adalimumab (Humira°), has jointly funded a public awareness campaign produced by the patient organisation France Psoriasis. Objective: marketing.

Full text available for free download.

Hydroxychloroquine: the situation is critical

EDITORIALAccording to the methodological principles of clinical evaluation, comparative trials provide the most reliable evidence when evaluating treatments. The lowest-level evidence comes from expert opinions, case series, other observational studies and empiricism. This is still true in 2020 – and also in covid-19.

Gentian violet used when breastfeeding: irritant and carcinogenic

Gentian violet has no place in the treatment of nipple thrush while breastfeeding, nor of oral thrush in the newborn baby.

Pinworm infection: easy to detect and easy to treat

Anal itching at night is highly suggestive of pinworm infection, an intestinal parasitic infection that is very common in children. Several drugs, none of which have serious adverse effects, eradicate the parasites, after two doses, given two weeks apart.

Proton pump inhibitors: increased risk of severe covid-19

NEWS UPDATE Proton pump inhibitors (PPIs) are known to increase the risk of various infections, including pneumonia and pseudomembranous colitis. What about covid-19 infection? A recent study yields some useful information.

Covid-19 patients who are not hospitalised: anticoagulation is rarely justified

NEWS UPDATE The risk of thromboembolism in patients with a mild to moderate form of covid-19 is unclear and probably varies greatly between patients. Is anticoagulation justified to prevent deep vein thrombosis in patients with covid-19 who are not hospitalised?

Cannabidiol (Epidyolex°) in certain severe forms of childhood epilepsy: an option to consider, but liver function must be monitored

FEATURED REVIEW Cannabidiol (Epidyolex°) has been granted marketing authorisation in the European Union for patients aged 2 years and older with Lennox-Gastaut syndrome or Dravet syndrome, in combination with antiepileptic treatment including at least clobazam. How do Prescrire's editors rate this treatment in this situation?
Full text (3 pages) available for download by subscribers.

In the September issue of Prescrire International. VEGF inhibitors: arterial aneurysm and dissection

FREE DOWNLOAD Drugs that target vascular endothelial growth factor (VEGF) inhibit angiogenesis and are mainly used to treat diseases involving vascular proliferation, in particular cancer and certain eye conditions (by intravitreal administration). They can provoke cardiovascular disorders such as hypertension, heart failure and arterial or venous thromboembolic events.

Full text available for free download.

Evidence required: for covid-19 too

EDITORIALAside from the covid-19 epidemic's many major public-health and economic consequences around the world, it has also raised questions for many people about drug evaluation and the need for evidence before using a drug to treat patients.

Mild asthma: adapt treatment according to patients’ needs

An inhaled beta-2 agonist as needed, possibly combined with an as-needed or continuous inhaled corticosteroid.

Priapism: urgent medical attention required

Priapism, an erection lasting several hours, needs to be diagnosed quickly in order to prevent possibly irreversible erectile dysfunction. It is often caused by medications.

Drug shortages: a source of errors and adverse events, which should be reported

Drug shortages did not begin with the covid-19 epidemic. Some shortages cause serious harm to patients. Healthcare professionals and patients should report any adverse events related to drug shortages to the competent authorities.

Hydroxychloroquine in covid-19: no proven efficacy, including in less severe forms of the disease

NEWS UPDATE The detailed results of four comparative trials of hydroxychloroquine in patients with covid-19 were released in late July 2020: two trials in patients hospitalised for covid-19, and two others in patients who were not hospitalised and had milder forms of the disease.

Covid-19: remdesivir (Veklury°) authorised in the European Union, yet much remains unknown or uncertain

NEWS UPDATE The antiviral drug remdesivir was authorised in the European Union in early July 2020 for the treatment of certain adults and adolescents with severe covid-19 requiring supplemental oxygen. It was only granted conditional authorisation, because the data submitted were incomplete on many fronts. The drug company needs to resolve many uncertainties surrounding remdesivir's adverse effects and efficacy.

Covid-19 and severe breathing problems: dexamethasone reduced mortality in one trial

NEWS UPDATE Some detailed preliminary results were released on 23 June 2020 from a randomised trial in patients hospitalised for covid-19 (the “Recovery” trial). Adding the corticosteroid dexamethasone (for up to 10 days) to usual care reduced 28-day mortality in patients receiving oxygen or mechanical ventilation, but appeared unnecessarily dangerous in other patients.

Andexanet alfa (Ondexxya°) as an antidote to xabans: inadequate clinical evaluation

FEATURED REVIEW The evaluation of andexanet alfa for the management of severe bleeding in patients receiving apixaban or rivaroxaban is inadequate. When bleeding occurs in a patient receiving a xaban, the key action is to put in place proven emergency supportive measures.
Full review (4 pages) available for download by subscribers.

In the July-August issue of Prescrire International: aflibercept (Eylea°) in diabetic macular oedema without visual impairment

FREE DOWNLOAD What is the efficacy of aflibercept in patients with diabetic macular oedema without visual impairment at the time of diagnosis?

Full text available for free download.

Proper evaluation, for patients' sake

EDITORIALProper drug evaluation, based on trials designed to provide sufficiently high-level evidence and conclusive results, using patient-relevant clinical outcomes, is the best way of ensuring that drugs are used judiciously, without causing unnecessary harm.

Pulmonary arterial hypertension: sometimes drug-induced

Many drugs can cause pulmonary arterial hypertension, which sometimes improves when treatment is halted.

Prescrire's annual drug packaging review: slow progress and dangers

The drug packaging market is improving, but there are also still many examples as of 2020 that pose a danger to patients, in particular children and pregnant women. These flaws affect prescribers, pharmacists and nurses through the complications they cause.

Illustrated examples of dangerous drug packaging, from Prescrire's annual packaging review

A drug’s packaging (box, bottle, leaflet, etc.) is crucial in preventing administration errors. Three examples from Prescrire's annual drug packaging review illustrate the types of packaging flaws we identified as dangerous in 2019, flaws which have long been known to health authorities.

Intra-articular hyaluronic acid injection for knee osteoarthritis: efficacy and adverse effects underestimated?

Queries and Comments Prescrire concluded in 2016 that the harm-benefit balance of hyaluronic acid by intra-articular injection seemed unfavourable. Several readers have since expressed their profound disagreement, citing the effects noted in their daily practice. How can such a difference be explained? Could the clinical data available in 2020 potentially call Prescrire's conclusions into question?

Increased risk of skin cancer with hydrochlorothiazide: what are the practical consequences?

Queries and Comments In 2018, Prescrire reported the findings of two case-control studies that showed an increased risk of non-melanoma skin cancers in patients treated with hydrochlorothiazide, a first-choice antihypertensive drug. Does the evidence available in 2020 affect this drug's harm-benefit balance in hypertension?

Lack of access to drug evaluation data: a recurrent problem, not confined to covid-19

NEWS UPDATE An article reporting the results of pharmacoepidemiological studies on the use of hydroxychloroquine in covid-19 has been retracted. The reasons given centre on the fact that access to the raw data was only granted to certain authors. This is a recurrent problem, not confined to evaluations of drugs for covid-19.

Dabrafenib (Tafinlar°) and trametinib (Mekinist°) combined, as adjuvant therapy for stage III melanoma with a BRAF V600 mutation

FEATURED REVIEW This combination has now been authorised in the European Union for the adjuvant treatment of patients with melanoma and lymph node involvement but no other metastases, when the tumour cells express a BRAF V600 mutation. Does this combination extend survival in this situation? Does it reduce the incidence of recurrence? What more is known about its adverse effects?
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International: Antispasmodics during pregnancy, in brief

FREE DOWNLOAD Various drugs termed antispasmodics are offered to treat pain of gastrointestinal, urinary or gynaecological origin, often despite unconvincing evaluation. What are the risks to the mother and the unborn child when taken during pregnancy?

Full article available for free download.

Curiosity is an admirable quality

Editorial How is it that the link between benfluorex (formerly marketed under the brand name Mediator°) and heart valve disease was unrecognised for decades by most French cardiologists? Despite the drug’s widespread use, the frequency of these valve disorders, and constant advances in echocardiography?

Drug-induced heart valve disease: a blind spot for cardiologists

Exposure to benfluorex (Mediator°) caused hundreds of deaths in France, in particular from heart valve disease. Before the withdrawal of Mediator°, many cardiologists attributed these drug-induced valve disorders to other causes, often rheumatic heart disease, even though rheumatic fever had long since become very rare.

Prescrire: independence and transparency, in the name of better patient care

Tramadol: an opioid analgesic to be used with caution

Classified as a weak opioid, tramadol poses risks that require the same vigilance as with morphine.

Thyroid hormone treatment: no proof of benefit in asymptomatic subclinical hypothyroidism

According to a systematic review of comparative trials in approximately 2 000 patients, symptomless hypothyroidism discovered incidentally does not require thyroid hormone treatment (levothyroxine).

Measles-mumps-rubella vaccine (MMR): no link with autism

FEATURED REVIEW Studies based on a very significant number of children, taken together, do not show any link between MMR vaccination and the occurrence of autistic disorders. The authors of the two studies claiming the opposite used incorrect data or applied inappropriate analytical methods.
Full review (3 pages) available for download by subscribers.

In the May issue of Prescrire International: Dulaglutide (Trulicity°) and type 2 diabetes. No reduction in all-cause mortality or cardiovascular mortality

FREE DOWNLOADIn patients with type 2 diabetes who had a modest elevation of HbA1c, a recent trial suggested that addition of dulaglutide to hypoglycaemic therapy slightly reduced the risk of stroke, but did not reduce either all-cause mortality or cardiovascular mortality.

Full text available for free download.

Rumours that kill

Health care is a field in which rumours flourish: it is not always easy to tell true from false or rumour from robust evidence. Health decisions are safest when based on data that have been extricated from the various forms of bias and influence that can distort information about health care.

Dry eye: sometimes associated with antimuscarinic drugs

When faced with a patient with dry eye, recognising the possible role of antimuscarinic drugs (also known as atropinics) helps in choosing the best treatment strategy: discontinuing these drugs or possibly replacing them with another drug, reducing the dose or introducing treatment to alleviate the symptoms of dry eye disease.

Pregabalin (Lyrica° or other brands) and gabapentin (Neurontin° or other brands): known dangers and uncertainties during pregnancy

Taken during pregnancy, pregabalin and gabapentin expose the newborn to harmful effects.

Cytotoxic drugs: risks for healthcare professionals

Exposure to cytotoxic drugs, which are often genotoxic, carcinogenic or reprotoxic, poses a risk to the health of healthcare and other professionals.

New data on the cardiac adverse effects of the combination of hydroxychloroquine (Plaquenil°) with azithromycin (Zithromax° or other brands)

NEWS UPDATE As of mid-April 2020, more and more clinical data are confirming that the combination of hydroxychloroquine (Plaquenil°) with azithromycin (Zithromax° or other brands) carries a risk of serious cardiac adverse effects: prolongation of the QT interval with a high risk of cardiac arrhythmia and torsade de pointes, and cardiovascular mortality, which is increased by the addition of azithromycin. Several cases of cardiac arrest have been reported.

Covid-19 and hydroxychloroquine (Plaquenil°): new data show no evidence of efficacy

NEWS UPDATE The results of a new randomised comparative but non-blinded trial of high-dose hydroxychloroquine (Plaquenil°) versus standard care in 150 patients hospitalised for covid-19 have been published. The only notable difference between the groups was the high incidence of adverse effects in the group treated with hydroxychloroquine. The results of other studies (non-randomised and providing only low-quality evidence) show no evidence that hydroxychloroquine has efficacy against covid-19.

Covid-19 and hydroxychloroquine (Plaquenil°): still no conclusive results

NEWS UPDATE On 9 April 2020, the Institut Hospitalo-Universitaire (IHU) Méditerranée Infection, Marseille, released a summary of a non-comparative study in 1061 people who had a positive PCR test result for Sars-CoV-2, the virus responsible for covid-19. Most had mild or no symptoms. All were treated with hydroxychloroquine and azithromycin. Most recovered within 10 days, as is the case, even without treatment, when symptoms are relatively mild. Without a control group, these results can neither confirm nor rule out the value of the treatment administered.

Covid-19 and hydroxychloroquine: uncertainties and unanswered questions

NEWS UPDATE Results of a comparative trial of hydroxychloroquine (Plaquenil°) in 62 patients were published at the end of March 2020. The remaining uncertainty in the wake of these results means that the comparative trials currently underway must be continued, and great care should still be taken in the use of hydroxychloroquine, given its cardiac and other harms.

Covid-19 and hydroxychloroquine: caution

NEWS UPDATE Hydroxychloroquine was not shown to be effective in a randomised trial in 30 patients with covid-19, the results of which were published in China in early March 2020. The hypothesis that this drug sometimes worsens covid-19 has not been ruled out. Short-course treatment with hydroxychloroquine carries a risk of various adverse effects, some of which can be fatal, especially in the event of an overdose.

Pillflix3D°: an Innovative new manufacturing process that could revolutionise the way we solve medicines shortages

NEWS FLASH French researchers have announced the launch of Pillflix3D°, the world's first remotely manufactured tablet. Available by prescription for the treatment of severe capilloscinditis, this downloadable therapeutic solution has already been approved for reimbursement by France's national health insurance system. A revolutionary new process allows the patient and the care team to fully personalise the treatment by ticking boxes on a dedicated online interface.

• Watch out for acute shortages... of critical thinking!

To err is human, but when computers are involved, things can really get out of hand. Our ever-encroaching digital magic too often causes humans to put their critical faculties on hold. In these days of chronic drug shortages, contagious panic and an acute dependence on virtual everything, it's more vital than ever to hang on to one's good old-fashioned thinking cap.

Lithium during pregnancy: malformations, fetotoxicity and uncertain long-term effects

FEATURED REVIEW Outside the context of pregnancy, lithium is the standard "mood stabiliser" for the treatment of bipolar disorder. What are the main known short-term and long-term consequences of in utero exposure to lithium?
Full review (3 pages) available for download by subscribers.

In the April issue of Prescrire International: Denosumab (Prolia°) and steroid-induced osteoporosis

FREE DOWNLOAD Denosumab (Prolia°) has an unfavourable harm-benefit balance in the prevention of osteoporotic fractures. It has also been authorised in the prevention of osteoporosis induced by prolonged corticosteroid therapy. How do Prescrire's editors rate denosumab in this situation?

Full text available for free download.

Drugs in 2019: a brief review

Eleven of the 108 new drugs, combinations, dose strengths, pharmaceutical forms or indications analysed and rated in our French edition in 2019 constituted a notable therapeutic advance, improving patient care in a variety of fields: haemophilia, various cancers, HIV infection, hepatitis C and rare diseases.

Drugs in 2019: therapeutic advances, compared with the previous 9 years

GRAPHICS From Prescrire's recap "Drugs in 2019: a brief review", graphics comparing the therapeutic advances during 2019 with the advances made in prior years, along with a table summarising Prescrire's ratings of new products and indications over the past 10 years.

France's Mediator° disaster: creating awareness around conflicts of interest

Media coverage of the Mediator° disaster in 2010-2011 opened the public’s eyes to the conflicts of interest of many experts working for the French drug regulatory agency. Have health care professionals realised that these conflicts damage credibility, patient confidence and quality of care?

Zolgensma°: the drug of extremes

For some years now, the escalating cost of new drugs has increasingly threatened access to health care. In 2019, Zolgensma° (onasemnogene abeparvovec-xioi) reached the absurd price of about 2 million euros for the single injection that is required to treat each patient.

Covid-19 and drug trials: what to make of the initial results?

NEWS UPDATE As of 23 March 2020, there are no relevant clinical trial results demonstrating the efficacy of hydroxychloroquine, either alone or in combination with azithromycin. And no efficicacy has been proven for the lopinavir + ritonavir combination in severe covid-19, according to the results of a randomised controlled trial. Until more is known, the hypothetical efficacy of the proposed treatment must be weighed against its known or predictable adverse effects, to avoid making things even worse.

"Top Texts of 2020", from the editors of Prescrire International

FREE SPECIAL EDITION Check out this sampling of texts from Prescrire International, a wholly independent monthly journal written by and for healthcare professionals. Inside, top articles from our "New Products", "Adverse Effects" and "Reviews" sections, plus our annual update of drugs to avoid. > Click here for your free copy

Darvadstrocel (Alofisel°) for complex perianal fistulae in Crohn's disease. A rash marketing authorisation decision

FEATURED REVIEW How effective is darvadstrocel (Alofisel°) in healing perianal fistulae after usual treatments have failed? Does it reduce the need for surgical intervention? And what are darvadstrocel's adverse effects?
Full review (4 pages) available for download by subscribers.

In the March issue of Prescrire International: Dengue vaccine (Dengvaxia°). Not for large-scale use

FREE DOWNLOAD Dengvaxia°, a vaccine containing live attenuated viruses expressing antigens of the 4 known dengue virus serotypes, has been granted marketing authorisation in the European Union. How do Prescrire's editors rate this vaccine's harm-benefit balance?

Full text available for free download.

Protecting patients: France's Transparency Committee steps in

As evidenced by Prescrire's annual update of drugs to avoid in the name of better patient care, many drugs remain authorised for years despite an unfavourable harm-benefit balance. How then can patients and community resources be protected?

Painful endometriosis: initial treatment options

In the absence of urinary or intestinal symptoms, and if the patient is not planning to become pregnant any time soon, first try analgesics such as NSAIDs or paracetamol. Hormonal contraception or a levonorgestrel intrauterine device are other options.

Rotarix° oral vaccine: wrong-route errors

The Rotarix° oral vaccine applicator has a deceptive syringe-like appearance, which has resulted in intramuscular injections being given in error.

Drugs to avoid in the name of better patient care: 2020 update

The independent French medical journal Prescrire's annual review of drugs to avoid includes documented cases of 105 drugs authorised in the European Union that are more dangerous than beneficial. The aim is to make it easier to choose safe, effective treatments, primarily to avoid exposing patients to unacceptable harms.

Annual Prescrire Drug Awards announced in Paris: 6 winning drugs, but no "Pilule d'Or"

The independent French medical journal Prescrire announced its Drug Awards for 2019, at its yearly awards ceremony in Paris on 30 January. Three drugs made the "Honours List" and three others were recognised as "Noteworthy", but there was no "Pilule d'Or" (Golden Pill) awarded this year.

The Prescrire Packaging Awards for 2019: one winner and plenty of losers

The independent French medical journal Prescrire held its annual awards ceremony in Paris on 30 January. A Prescrire Packaging Award recognised Isentress° granules for oral suspension (raltegravir) for its clear, informative instruction booklet, whereas 34 "Red Cards" were handed out for substandard or dangerous packaging.

Prescrire's Information Awards for 2019: just 6 drug companies (out of 112 contacted) are honoured for the quality of information provided

Prescrire's annual Information Awards recognise drug companies which respond to Prescrire's requests with complete and relevant information. In 2019, only a half-dozen drug companies (out of 112 companies contacted by Prescrire's editors with information requests) embraced transparency, in the best interest of patients.

Baclofen (Baclocur°) and alcohol dependence. At moderate doses, a modest aid in controlling alcohol consumption

FEATURED REVIEW The GABA analogue baclofen (Baclocur°, Ethypharm), used since the 1970s as a muscle relaxant, has now been granted marketing authorisation in France for the reduction of alcohol consumption in alcohol-dependent patients in whom the other drug treatments have failed. What is known about baclofen's harm-benefit balance in this clinical situation as of late 2019?
Full review (4 pages) available for download by subscribers.

In the February issue of Prescrire International - High thrombotic risk and antiphospholipid antibodies: avoid direct oral anticoagulants

FREE DOWNLOAD In the Adverse Effects section this month: should patients taking a direct oral anticoagulant switch to a vitamin K agonist such as warfarin, in light of the French drug regulatory agency's recent advisory?

Full text available for free download.

SSRI antidepressants: persistant sexual dysfunction

Antidepressants known as selective serotonin reuptake inhibitors (SSRIs) expose patients to sexual adverse effects that may persist long after discontinuation of the drug.

Severe vomiting in pregnancy: the priority is to rehydrate

In cases of severe nausea and vomiting during pregnancy, priority treatment combines parenteral rehydration and rest.

Oral desensitisation to peanuts: too many adverse effects

Oral desensitisation to peanuts increases rather than reduces the risk of subsequent serious allergic reactions.

Antiepileptics and pregnancy: potential long-term effects in children

FEATURED REVIEW Many women who could become pregnant are exposed to antiepileptic drugs. Yet most of the antiepileptic drugs taken by pregnant women expose the unborn child to the risk of malformations, fetotoxic effects and neonatal disorders. What are the long-term effects of the most widely used antieleptics on children exposed in utero, and how do they compare?
Full review (8 pages) available for download by subscribers.

In the January issue of Prescrire International - Dapagliflozin in type 2 diabetes: no advance in terms of cardiovascular complications

FREE DOWNLOAD In the "Reviews" section this month: what is dapagliflozin's harm-benefit balance in type 2 diabetes, in light of the results of a recent randomised, double-blind trial studying the drug's effect on cardiovascular outcomes?

Full text available for free download.

Persistent psychotic disorders: avoid combining neuroleptics

Combining oral neuroleptics cumulates adverse effects but offers no proven benefits.

The common cold: echinacea purpurea is no better than placebo

There is no known drug, herbal medicine or other remedy that reduces the intensity or duration of cold symptoms and has a favourable harm-benefit balance.

Vitamin B6: overdoses leading to neuropathies

With few exceptions, consuming vitamin B6 in addition to food has no medical justification and can lead to overdoses with peripheral neuropathies.

Updated list of "Drugs to avoid, in the name of better patient care" is published by independent French journal Prescrire

Emicizumab (Hemlibra°) in haemophilia A. A first-choice preventive treatment for patients with factor VIII inhibitors

FEATURED REVIEW Prescrire's editors have rated emicizumab prophylaxis in patients with haemophilia A in whom factor VIII is no longer effective due to the development of factor VIII inhibitors "a real advance". Reduced incidence of bleeding and greater convenience should be weighed against the lack of long-term data, the lack of evaluation in certain clinical situations, and the risk of thrombosis.
Full review (2 pages) available for download by subscribers.

In the December issue of Prescrire International: pertuzumab (Perjeta°) after surgery for some breast cancers at high risk of recurrence

FREE DOWNLOAD Pertuzumab (Perjeta°) is a monoclonal antibody which has been authorised for use after surgery for some breast cancers. How do Prescrire's editors rate the drug's harm-benefit balance in this situation, in light of the most recent evidence?

Full text available for free download.

The Mediator° disaster: so much time wasted, so many lives destroyed

The independent French medical journal Prescrire began asking questions about the appetite-suppressant drug Mediator° (benfluorex) in 1986, and called for its withdrawal some 12 years before the French authorities finally took action. In our special online section, a recap of how the disaster unfolded, and the tragic consequences for victims.

Diclofenac: a habit that needs changing

Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), is routinely used, despite evidence of a greater risk of adverse cardiovascular events when compared with other NSAIDs such as ibuprofen or naproxen, whereas it offers no additional benefit.

Anti-inflammatory drugs: risks for the kidneys even in young, healthy adults

Taking nonsteroidal anti-inflammatory drugs (NSAIDs) presents risks of nephrotoxicity in young people during intense physical exercise, especially in hot weather.

Sore throat: paracetamol is the best option

Nonsteroidal anti-inflammatory drugs (NSAIDs) appear to be somewhat more effective than paracetamol, but they expose patients to more serious side effects.

Dolutegravir + rilpivirine (Juluca°) dual therapy in HIV infection

FEATURED REVIEW First-line therapy for patients with HIV infection is usually based on triple therapy. When sustained virological suppression has been achieved, treatment "simplification" can sometimes be considered. Is the two-drug regimen dolutegravir + rilpivirine (Juluca°) any better than other treatment options?
Full review (3 pages) available for download by subscribers.

In the November issue of Prescrire International - Gliptins: joint pain and exposure to NSAIDs

FREE DOWNLOAD In the Adverse Effects section of the November issue, the results of a study by the independent French medical journal Prescrire, based on data from France's national health insurance system.

Full text available for free download.

Gemtuzumab ozogamicin (Mylotarg°) in acute myeloid leukaemia: no proven benefits

According to currently available clinical evaluation data, gemtuzumab ozogamicin (Mylotarg°) does not provide tangible benefits for patients with acute myeloid leukaemia.

Fenspiride (Pneumorel°): serious adverse effects reported over two decades

Despite serious adverse effects reported for more than 20 years, fenspiride (Pneumorel°) was only withdrawn from the market in 2019.

Industrial protectionism and medicines: too many damaging effects

Pharmaceutical companies benefit from strong industrial protection which allows them to charge exorbitant prices for their medicines for a very long time.

New special section: "Mediator° - the criminal trial"

The independent French medical journal Prescrire began asking questions about the appetite-suppressant drug Mediator° (benfluorex) in 1986, and called for its withdrawal some 12 years before the French authorities finally took action. Meanwhile thousands of patients suffered serious, sometimes fatal, adverse effects. As the criminal trial opens in France, Prescrire looks back over the disaster, and analyses just what is at stake.

The 2019 "Prescrire Prize" is awarded in Paris to
3 noteworthy books about health and healthcare

The recipients of the 2019 "Prescrire Prize" book awards were announced on 3 October 2019. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Axicabtagene ciloleucel (Yescarta°) in certain types of lymphoma when other treatment options have been exhausted

FEATURED REVIEW Axicabtagene ciloleucel is a CAR (chimeric antigen receptor) T-cell therapy. It increases the chances of survival in certain situations but frequently provokes serious adverse effects. There is a pressing need for more thorough clinical evaluation.
Full review (3 pages) available for download by subscribers.

In the October issue of Prescrire International: clear shortcomings in the independence of French medical schools

FREE DOWNLOADInvestigation by a nonprofit organisation revealed poor application of a charter signed by deans of French medical and dental schools.

Full text available for free download.

"Faces of Mediator", a new book published by Prescrire

It was after seeing the French film "La Fille de Brest", an adaptation of the book by pulmonologist and whistle-blower Irène Frachon, that the photographer Marc Dantan first got the idea of taking portraits of the victims of Mediator° (benfluorex), in the hope that "bringing faces into the light could perhaps raise awareness of the silent suffering". That was the beginning of this book, which presents in 208 pages some 180 photographs, along with a foreword by Irène Frachon, a summary of the history of the Mediator° disaster, and an afterword by Prescrire. Texts in French and English.

Paracetamol: patients need to be more aware of the harms

In France, 20% of patients seem to be unaware that paracetamol is toxic at high doses, especially to the liver, and around 30% are unaware that alcohol aggravates this toxicity.

Secondary cardiovascular prevention: dubious benefits of evolocumab (Repatha°) and alirocumab (Praluent°)

In patients who have already had a cardiovascular event, the addition of evolocumab or alirocumab to a statin does not reduce mortality but does expose to adverse effects, although these are not well known.

Trials funded by drug companies: publication or publicity?

Pharmaceutical companies have a tight grip on the publication of the clinical study results that will allow them to obtain marketing authorisation for their products. A situation that is regrettable, but predictable.

Erenumab (Aimovig°) for the prevention of migraine attacks: decrease in the frequency of attacks in some patients, but uncertainty over cardiovascular effects

FEATURED REVIEW Erenumab (Aimovig°) is a monoclonal antibody that has been authorised in the European Union for the prevention of migraine attacks in patients who experience attacks on more than 4 days a month. Prescrire's editorial staff have weighed the available evidence to bring you an unbiased assessment of the drug's harm-benefit balance.
Full review (5 pages) available for download by subscribers.

In the September edition of Prescrire International: sartan medicines contaminated by impurities which are probable carcinogens

FREE DOWNLOAD The exposure of patients all around the world and over a period of several years to impurities which are known to be carcinogenic, and which were present in commonly used medicines, shows that the systems intended to guarantee pharmaceutical quality need to be improved.

Full text available for free download.

Carpal tunnel syndrome: sometimes drug-related

Carpal tunnel syndrome is sometimes caused by certain drugs, and disappears when the medication is stopped.

New drugs: investing in more informative clinical trials

More informative clinical trials are more expensive, but that is the price of better care.

Fluoroquinolones: use should be restricted due to severe adverse effects

Given the many and sometimes severe adverse effects of fluoroquinolone antibiotics, they should only be used for limited purposes.

Psychotic episode: which oral neuroleptic to choose? A choice tailored to each patient, based on the adverse effect profiles of the options

FEATURED REVIEW Neuroleptic drugs have been widely used since the 1950s to treat psychotic episodes. When an oral neuroleptic appears justified for treating a psychotic episode in an adult, which drug should be chosen?
Full review (7 pages) available for download by subscribers.

In the July-August issue of Prescrire International: emtricitabine + tenofovir disoproxil (Truvada° and other brands) for prevention of HIV infection in adolescents

FREE DOWNLOAD Based on extrapolation of the data obtained in adults, the emtricitabine + tenofovir disoproxil combination (Truvada° or other brands) appears worth offering to adolescents whose sex practices place them at particularly high risk of contracting HIV infection.

Full text available for free download.

Fentanyl (Actiq° and other brands) and other opioids: risk of increased pain

Paradoxically, fentanyl, like other opioids, can exacerbate the pain it is intended to relieve.

Prescrire's packaging review for 2018: ways to reduce dangers

A drug's packaging (box, bottle, delivery device, leaflet, etc.) is especially important in preventing patient errors in taking the drug. Hence the usefulness of Prescrire's methodical analysis.

A clear example of marketing's influence on prescribers

Lung specialists have been influenced by marketing to prescribe new drugs that do not bring any benefits for patients with COPD.

Methylphenidate (Ritalin° and other brands) during pregnancy: teratogenic and fetotoxic, with concerns about long-term effects

FEATURED REVIEW Methylphenidate is an amphetamine-like psychostimulant used in attention deficit hyperactivity disorder (ADHD). Recent studies have revealed important data about the consequences of in utero exposure to methylphenidate for the unborn child, in the short and long term.
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International - Treatment of scabies: 5% permethrin cream or oral ivermectin?

FREE DOWNLOAD In patients with scabies, topical application of 5% permethrin cream and oral ivermectin have a similar harm-benefit balance. How do these two treatment options stack up?

Full text available for free download.

Independence and transparency: the words Prescrire lives by

The independent French medical journal Prescrire is 100% financed by its subscribers, guaranteeing freedom from the influence of the special interests – be they industrial or institutional – that are omnipresent in the healthcare arena.

Atrial fibrillation: apixaban (Eliquis°) as an alternative to warfarin (Coumadin° and other brands) in some situations

When atrial fibrillation warrants the use of an anticoagulant, the anti-vitamin K warfarin (Coumadin° and other brands) is still the best long-term evaluated oral anticoagulant. The anti-Xa apixaban (Eliquis°) is an alternative in some situations.

Ginkgo biloba: to be avoided due to severe adverse effects

In practice, it is better to avoid this plant, which has no proven efficacy and exposes patients to serious adverse effects, including convulsions.

Useful tips for informing patients about risks

The vast majority of patients would like more explanations in order to better understand their state of health and to participate in therapeutic choices that affect them. How can healthcare professionals deliver this?

Drug-induced retinal disorders

FEATURED REVIEW Retinal damage can cause different types of visual disturbances, of varying severity. Many drugs can provoke retinal disorders. What are the underlying mechanisms? Which drugs are responsible?
Full review (4 pages) available for download by subscribers.

In the May issue of Prescrire International: Dupilumab (Dupixent°) in adults with atopic dermatitis

FREE DOWNLOAD Dupilumab (Dupixent°), a monoclonal antibody, is an option for very troublesome eczema after failure of ciclosporin. Full text available for free download.

Vaccine hesitancy: understand it better, to provide better support

Rather than considering people reluctant to vaccinate as irresponsible, it is better to try to restore confidence by improving public knowledge, identifying the barriers and seeking ways to overcome them.

Drugs for Alzheimer's disease: reduction in the number of prescriptions is too slow

A study conducted by the independent French medical journal Prescrire shows a reduction of only around 26% in the number of patients in France exposed to at least one Alzheimer's disease drug between 2012 and 2017. In approximately 3 out of 4 newly exposed patients, treatment lasted for more than 6 months, despite the proven harms.

Methylphenidate (Ritalin°) as a means of controlling classroom behaviour

Too many children are overdiagnosed with attention deficit hyperactivity disorder (ADHD) simply because they are the youngest in the class and so tend to be more easily distracted and disruptive.

"Opioids: Conflicts & Controversies" a conference to be held in Washington, D.C. on 12-14 June 2019

Organised by the non-profit group PharmedOut, the conference will include discussions on the role of pharmaceutical marketing in creating and perpetuating the opioid epidemic.

Innovative new research on "high dilutions" could change in the way we look at pharmacology

NEWS FLASH While some remain mired in a sterile debate over whether or not homeopathy is "fake medicine", highly rigorous researchers have announced great strides in the area of "high dilutions", opening up a whole new era in critical thinking. The results, reported in the April edition of La revue Prescrire, could call into question the very foundations underlying all pharmacological principles.

• Decline in vigilance: water, water, everywhere...

Water, water everywhere! And not a drop of critical judgement. There's been a lot of water under the bridge since certain French researchers dove in at the deep end over just what water can and can't do. And now we have "highly rigorous researchers" and their findings on the properties of aqua naturalis. A reminder to always test the waters before you get your feet wet.

Drugs to avoid in 2019

FEATURED REVIEW To make it easier to choose quality care, and to prevent disproportionate harms to patients, Prescrire has published its annual update of drugs to avoid. Using a reliable, rigorous and independent methodology, Prescrire's editors identified 93 drugs currently authorised in France or the European Union that are more harmful than beneficial in all the approved indications.
Full review (10 pages) available for free download.

In the April issue of Prescrire International - Drugs in 2018: a brief overview

FREE DOWNLOAD In 2018, 99 new products or new indications were reviewed and rated in our French edition. Of the 35 that were deemed to advance patient care, 13 constituted a notable advance and 22 were rated "Possibly helpful", while 50 drugs were judged to be "nothing new".

Full text available for free download.

Prescrire's ratings of new products and indications over the past 10 years

Each spring, Prescrire International publishes a recap of the drugs reviewed in our French edition during the previous year. It includes a table summing up the ratings Prescrire's editors gave to the new drugs and indications reviewed during each of the past ten years.

Therapeutic advances in 2018 compared with the previous 10 years

Our recap of the drugs reviewed in our French edition La Revue Prescrire during the previous year includes a graphic summing up the ratings Prescrire's editors gave to new drugs and indications, compared with the previous ten years.

Multiple sclerosis: wasted opportunities

The drugs on the market have been so poorly evaluated that healthcare professionals are not able to make the best use of the available treatments, to the detriment of patients.

Pregnancy and lower urinary tract infection: opt for cefuroxime

Requiring just a single dose, fosfomycin trometamol is easier to take than cefuroxime or the combination of amoxicillin + clavulanic acid, but less is known about its short-term effects on the unborn child exposed during the first trimester of pregnancy. It is wiser to choose cefuroxime as first-line treatment.

High-strength insulins: think and act in units of insulin to prevent errors

FEATURED REVIEW At home as in hospital (and other healthcare facilities), errors associated with insulin use are numerous, frequent and can have serious consequences. How can dosing errors due to the coexistence of different strengths of insulin on the market be prevented?
Full review (2 pages) available for download by subscribers.

In the March issue of Prescrire International: Minor ischaemic stroke and antiplatelet drugs

FREE DOWNLOADIn this month's free sample text, the results of a trial confirming that after a minor stroke or transient ischaemic attack there is very little advantage from adding clopidogrel to aspirin, which remains the first-choice antithrombotic.

Full text available for free download.

Melatonin: significant adverse effects

Melatonin is not a treatment of choice for sleep disorders: its efficacy beyond that of a placebo is uncertain, and it carries a risk of neuropsychological, cutaneous, gastrointestinal and other adverse effects.

Publicly-funded research: too opaque!

France's top clinical research institutions, like many public organisations or private foundations financing clinical trials around the world, are not up to the mark when it comes to clinical research transparency.

The annual Prescrire Awards are given out in Paris: 5 winning drugs, but no "Pilule d'Or"

The independent French medical journal Prescrire announced its Drug Awards for 2018, at its yearly awards ceremony in Paris on 31 January. There was no "Pilule d'Or" (Golden Pill) award, but two drugs made the "Honours List" and three others were recognised as "Noteworthy".

The Prescrire Drug Packaging Awards for 2018: no winners and a lot of losers

Palmarès du conditionnement de Prescrire

The independent French medical journal Prescrire held its annual awards ceremony in Paris on 31 January. There were no Packaging Awards this year, whereas 25 "Yellow Cards" or "Red Cards" were handed out for substandard or dangerous packaging.

Prescrire's Information Awards for 2018: just 7 drug companies (out of 86 contacted) are honoured for the quality of information provided

Prescrire's annual Information Awards recognise drug companies which respond to Prescrire's requests with complete and relevant information. The picture in 2018 was no better than in prior years: only a few drug companies embraced transparency, in the best interest of patients.

Updated list of "Drugs to avoid, in the name of better patient care" is published by independent French journal Prescrire

In conjunction with the annual Prescrire Drug, Packaging and Information Awards, the independent French medical journal Prescrire has published its annual review identifying drugs that are clearly more harmful than beneficial. The full report will be published in English in the April issue of Prescrire International.

Simple febrile seizures in a child. First-choice treatments

FEATURED REVIEW Febrile seizures occur in around 3% of children. What are the essential points for healthcare professionals to keep in mind? And what are the warning signs to look out for?
Full review (4 pages) available for download by subscribers.

In the February issue of Prescrire International: Midostaurin (Rydapt°) for some types of acute myeloid leukaemia

FREE DOWNLOAD In this month's sample review, Prescrire's editors give this multi-tyrosine kinase inhibitor a rating of "Offers an advantage", but warn that the drug's adverse effects are underestimated.

Full text available for free download.

MRI during pregnancy: the pros and cons should be carefully assessed

Before deciding to give a pregnant woman an MRI scan, with or without contrast agents, it is important to consider how the MRI results would change the clinical course.

Proton pump inhibitors: increased mortality

FEATURED REVIEW Proton pump inhibitors (PPIs) such as omeprazole are used in oesophagitis, gastroesophageal reflux disease and peptic ulcer disease. PPIs have few severe adverse effects in the short term. But this is not the case in the long term.
Full review (3 pages) available for download by subscribers.

In the January issue of Prescrire International: Pembrolizumab (Keytruda°) in urothelial carcinoma

FREE DOWNLOAD In this month's sample review: Prescrire's editors rate pembrolizumab (Keytruda°) "Possibly helpful" in certain patients with locally advanced or metastatic urothelial carcinoma.

Full text available for free download.

Nonsteroidal anti-inflammatory drugs in pharyngitis: risk of peritonsillar abscess

To relieve fever or sore throat, it is better not to use nonsteroidal anti-inflammatory drugs (NSAIDs), but to use paracetamol instead.

Drug companies enjoy impunity from EU authorities

Under European regulations, the European Commission can only impose a financial penalty on drug companies if their infringement has "substantial consequences for public health" and if they do not co-operate during the proceedings brought against them.

COPD exacerbation: no systematic use of antibiotics

For episodes of moderate aggravation in patients with chronic obstructive pulmonary disease (COPD), it is preferable to prescribe antibiotics as a first-line treatment only when the suspicion of bacterial infection is reinforced by an increase in sputum purulence.

Healthcare-related errors: describe them in detail to understand them better

FEATURED REVIEW The realisation that a healthcare-related adverse effect was preventable is not enough to prevent similar errors. Error prevention also requires an understanding of the root causes, through in-depth analysis, preferably with everyone involved, including the patient.
Full review (5 pages) available for download by subscribers.

In the December issue of Prescrire International: Stable angina and antithrombotic drugs

FREE DOWNLOAD Addition of rivaroxaban (Xarelto°) to aspirin increases the risk of serious bleeding, but it has not been shown that the harm-benefit balance of this addition is favourable. Aspirin alone remains the first-choice antithrombotic drug in the majority of patients with coronary disease.

Full text available for free download.

Opioid overdose: an antidote to be administered promptly

Naloxone nasal spray (Nalscue°) is easy to use, and can save the lives of people who have overdosed on opioids.

Drugs for hepatitis C: it's time to slash prices!

The high prices of hepatitis C drugs are an obstacle to treatment for most of the people around the world who are infected by the virus.

Avoid pregnancy during treatment with valproic acid or its derivatives

New measures have been taken in the European Union to prevent the exposure of fetuses to valproic acid and its derivatives.

Drug-induced gynaecomastia

FEATURED REVIEW Drug-related proliferation of male breast tissue generally subsides after discontinuation of the substance that caused it. This must be weighed against the potential disadvantages of stopping treatment or substituting another drug.
Full review (5 pages) available for download by subscribers.

In the November issue of Prescrire International: Ending pharmaceutical sales representatives' access to hospitals and students

FREE DOWNLOAD In-person promotion of drugs to healthcare professionals by pharmaceutical sales representatives, known as pharmaceutical detailing, has been shown to influence doctors' prescribing behaviour. A US study looked at ways to limit this influence.

Full text available for free download.

Alcohol dependence: the risks of high-dose baclofen

With high-dose baclofen, there is an increased risk of epilepsy, infection, myocardial infarction or suicidal thoughts.

Denosumab (Prolia°) and osteoporosis: an increasingly unfavourable harm-benefit balance

Reports of sometimes serious adverse effects tilt the harm-benefit balance of denosumab in the treatment of osteoporosis.

Venetoclax (Venclyxto°): another drug made available on the market too soon

Ventoclax inhibits a protein often present in abnormal lymphocytes in cases of chronic lymphocytic leukaemia. But does venetoclax extend the patient’s life span? We don’t know because we don’t have a comparative trial.

The 2018 "Prescrire Prize" is awarded in Paris to
4 noteworthy books about health and healthcare

The recipients of the 2018 "Prescrire Prize" book awards were announced on 4 October 2018. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Bezlotoxumab (Zinplava°) and recurrence of C. difficile infection: No proven effect against serious complications, and cardiotoxicity

FEATURED REVIEW Given the serious complications associated with Clostridium difficile infection, treatment that safely reduces the risk of recurrences in high-risk patients would constitute a therapeutic advance. Bezlotoxumab's ability to deliver this advance has not been demonstrated. Full review (2 pages) available for download by subscribers.

In the October issue of Prescrire International - Dexrazoxane in children: European disagreements and arbitration

FREE DOWNLOAD In 2017, dexrazoxane was re-approved in the European Union for use in children treated with high doses of anthracyclines. However, uncertainties remain.

Full text available for free download.

Pregnant women and poor sleep: medication is rarely the right solution

In the case of poor sleep during pregnancy, sedatives are rarely the right solution. Non-drug measures are preferable.

Healthcare professionals are influenced by meals paid for by drug companies

Meals, even inexpensive ones, are very effective gifts because they exploit fundamental psychological reactions, promoting goodwill and making the beneficiary receptive to the sales message.

"Top Texts of 2018", from the Editors of Prescrire International

FREE SPECIAL EDITION Check out this sampling of texts selected by our Editors to introduce you to Prescrire International, a wholly independent monthly journal, written by and for healthcare professionals.

Smoking cessation: making repeated attempts with nicotine is safer than using varenicline (Champix° or Chantix°)

FEATURED REVIEW Varenicline, a partial agonist of nicotinic acetylcholine receptors, has been authorised since 2006 in the European Union for smoking cessation. In 2018, what is known about the harm-benefit balance of varenicline, and what role does it play in smoking cessation, compared to nicotine replacement therapy?
Full review (3 pages) available for download by subscribers.

In the September issue of Prescrire International - Silver sulfadiazine cream: disproportionate adverse effects

FREE DOWNLOAD The antibacterial agent silver sulfadiazine has been marketed in France since the 1970s for use as an antiseptic. It has only a marginal place in treatment, as a last resort.

Full text available for free download.

Telithromycin (Ketek°): a welcome market withdrawal

The company's decision to withdraw this antibiotic from the market is good news for patients, in view of the drug's negative harm-benefit balance. It is a pity that the European Medicines Agency did not muster the courage to order withdrawal of this drug long before.

Low back pain: no corticosteroids

There is no evidence that systemic corticosteroids have any efficacy on low back pain, beyond a placebo effect. Furthermore, they expose patients to numerous adverse effects.

David Young: A translator who helped expand Prescrire's international reach

David Young, who died recently, was more than a highly professional translator; he was a faithful colleague and friend of Prescrire's editorial team.

"Top Texts of 2018", new from the Editors of Prescrire International

NEW: FREE SPECIAL EDITION Check out this brand new sampling of texts selected by our Editors to introduce you to Prescrire International, a wholly independent monthly journal, written by and for healthcare professionals

Statins in primary cardiovascular prevention. Little benefit, documented harms and many uncertainties regarding long-term use

FEATURED REVIEW Given its weak efficacy and sometimes serious adverse effects, the harm-benefit balance of statin therapy in primary cardiovascular prevention is uncertain and close to neutral. Much else can be done to reduce cardiovascular risk via smoking cessation, physical activity and healthier eating habits.
Full review (8 pages) available for download by subscribers.

In the July/August issue of Prescrire International: pembrolizumab (Keytruda°) in Hodgkin lymphoma with no further treatment options

FREE DOWNLOAD The immunostimulatory anti-PD-1 antibody pembrolizumab (Keytruda°) has been authorised in the European Union for patients with relapsed or refractory Hodgkin lymphoma, in spite of inadequate premarketing assessment.

Full text available for free download.

Prescrire's review of drug packaging in 2017: some progress, but many risks remain

In 2017, unchallenged by overly lenient health authorities, a large number of pharmaceutical companies continued to launch, or to maintain on the market, drugs with dangerous packaging.

Multiple sclerosis: a drug that should never have been authorised

In March 2018, after several deaths, daclizumab (Zinbryta°) was withdrawn from the market. The European Medicines Agency should never have authorised this drug.

Drug prices, therapeutic value and access to medicines: civil society adds its voice to the debate in France, to defend the public interest

Several French organisations representing patients, healthcare users, healthcare professionals and students, including Prescrire, have joined together to publish a White Paper (in French) entitled: "Drugs and therapeutic advance: guaranteeing access, bringing prices under control".

Drugs for Alzheimer's disease: finally delisted in France!

The drugs available in mid-2018 for Alzheimer's disease have only minimal and transient efficacy. They have disproportionate, serious and sometimes fatal adverse effects. It is better to avoid them and to focus instead on reorganising the patient's daily life, keeping him or her active, and providing support and help for caregivers and family members.

Human papillomavirus 9-valent vaccine (Gardasil 9°) and cervical cancer. A few cases of dysplasia prevented, but an increase in painful reactions

FEATURED REVIEW A human papillomavirus (HPV) vaccine containing 9 HPV genotypes (Gardasil 9°) has been authorised in the European Union. The 9-valent vaccine provokes more, sometimes severe, injection site reactions, which could intensify existing misgivings about HPV vaccination.
Full review (2 pages) available for download by subscribers.

In the June issue of Prescrire International: anti-TNF alpha is linked to lymphoma; tropicamide eye drops present a risk of misuse

FREE DOWNLOADDownload this free page from the Adverse Effects section of the June issue, to get a sampling of the quality and diversity of the information published in every issue of Prescrire International.

Full text available for free download.

Antibiotics: repeated treatments before the age of two could be a factor in obesity

Antibiotics disrupt the intestinal flora (intestinal microbiota) and could be a factor in weight gain. Prescription of antibiotics for children should not be automatic but should be evaluated on a case-by-case basis.

Independence, in the service of patients' best interests

Prescrire is 100% financed by its subscribers, which guarantees its freedom from the influence of any special interests – be they industrial or institutional. This is the precondition for reliable, unbiased information and continuing education for healthcare professionals.

Wholly self-financed through subscriptions, Prescrire makes its accounts public every year

ABOUT PRESCRIRE The French journal Prescrire and its English edition Prescrire International are published by Association Mieux Prescrire, an independent, non-profit continuing education organisation. Prescrire accepts no advertising, grants or outside support of any kind, and publishes its financial statements every year.

Metopimazine: cardiac disorders

FEATURED REVIEW Metopimazine has received much less attention than domperidone in regard to its cardiovascular adverse effects, but the limited data available suggest that it probably exposes patients to a risk similar to that of domperidone.
Full review (4 pages) available for download by subscribers.

In the May issue of Prescrire International: Psychiatric disorders following in utero exposure to diethylstilbestrol (DES)

FREE DOWNLOAD In utero exposure to DES results in a variety of harmful effects, including long-term harms. Psychiatric disorders reported for "DES daughters" and "DES sons" include depression, bipolar disorder, behavioural disorders and schizophrenia.

Full text available for free download.

Exploratory trials, surrogate endpoints: not a robust basis for marketing authorisation

To serve the best interests of patients, it is more necessary than ever to base marketing authorisation decisions on robust data.

New cancer drugs: poorly evaluated, ineffective and overpriced

Many new cancer drugs are sold by drug companies at exorbitant prices, while their therapeutic benefit – when there is one – is usually modest.

Warts: beware of acid-based wart removers

In recent years, in France and elsewhere, deep burns and necrosis, sometimes with permanent after-effects, have been reported with concentrated acid-based topical wart removers.

"Preventing Overdiagnosis 2018": an international conference in Copenhagen, 20-22 August 2018

The not-for-profit group "Preventing Overdiagnosis", dedicated to "winding back the harms of too much medicine", has announced plans for its 2018 conference.

Treating intermittent claudication: first encourage patients to follow a walking exercise programme

FEATURED REVIEW Some patients with lower limb peripheral artery disease experience pain while walking, due to a reduced ability to increase arterial circulation. What is the harm-benefit balance of treatments aimed at improving their walking capacity?
Full review (5 pages) available for download by subscribers.

In the April issue of Prescrire International: Towards better patient care - drugs to avoid in 2018

FREE DOWNLOAD Prescrire's annual review of drugs to avoid covers all the drugs examined by Prescrire between 2010 and 2017 that are authorised in the European Union or in France. We identified 90 drugs that are more harmful than beneficial in all the indications for which they have been authorised.

Hepatitis C: sofosbuvir + velpatasvir (Epclusa°) represents an advance for some patients

The combination sofosbuvir + velpatasvir (Epclusa°) offers a therapeutic advance in the treatment of hepatitis C, especially in patients infected by a genotype 2 virus. But the uncertainty surrounding its adverse effects is unacceptable.

New drugs and indications in 2017: numerous innovations offering no progress

Marketing authorisations often granted too hastily: patients are exposed to medicines with uncertain harm-benefit balances.

Prescrire's ratings of new products and indications over the past 10 years

Tripoliponumab: French firm Neuronodev demands withdrawal of marketing authorisation and approves 150 million euros for patients

NEWS FLASH Tripoliponumab was authorised in 2017 for treatment of chronic prolonged daydream disorder. The French firm Neuronodev Pharma has just demanded that the European Medicines Agency withdraw the marketing authorisation, citing commercial reasons. The board has voted 150 million euros in damages, to be adjusted according to patients' perceived needs.

• Decline in vigilance: beware of collateral damage(s)

In your dreams! Lulled by far too much information swirling around us day and night, it's no wonder we sometimes have trouble distinguishing between dreams and reality. So much so that one could almost believe a drug company would actually take the initiative to limit, and to pay for, the damage caused by one of its products. But that would be living in a dream world.

Ceftazidime + avibactam (Zavicefta°). An option in the case of cephalosporin resistance

FEATURED REVIEW A ceftazidime + avibactam combination (Zavicefta°, Pfizer) has been approved in the European Union for the treatment of various “complicated” infections. In one clinical trial, the combination was as effective as a carbapenem and had an acceptable adverse effect profile.
Full review (2 pages) available for download by subscribers.

In the March issue of Prescrire International: the annual Prescrire Awards for drugs, packaging and information

FREE DOWNLOAD The three annual Prescrire Awards are granted in total independence by the Prescrire Editorial Staff, based on reviews published over the past year in our French edition.

Full text available for free download.

Hodgkin disease: two drugs that are not beneficial to patients

In the absence of any proven increase in life expectancy, there is no justification for exposing patients with Hodgkin disease to the many, sometimes severe, adverse effects of nivolumab (Opdivo°) and brentuximab vedotin (Adcetris°).

Hospitalised children: errors detected by parents and family members

During a child's hospitalisation, family members often detect adverse events and errors which are not noticed or reported by caregivers.

Early syphilis: screen and treat to prevent transmission

Syphilis is sometimes hard to identify, and so it is important to screen and treat the sexual partners of infected persons to prevent transmission.

EMA's advice to drug companies: conflicting roles

The European Medicines Agency (EMA) offers "scientific advice" to drug companies to help them compile their marketing authorisation applications, giving rise to suspicions that the agency may be placing pharmaceutical companies' interests over and above patients' health.

Prescrire's ratings system: new drugs and indications, at a glance

ABOUT PRESCRIRE Behind the annual Prescrire Awards, Prescrire's editors work year-round to assess whether or not new drugs and indications represent a therapeutic advance for patients. Ranging from "Bravo" to "Not Acceptable", Prescrire's ratings sum up the result of a unique, collective editorial process.

Injectable methotrexate and ectopic pregnancy. An alternative to surgery, but patients must be made aware of the risks

FEATURED REVIEW For some women with an ectopic pregnancy, intramuscular injection of methotrexate can be an alternative to surgery. But methotrexate carries the risks of a cytotoxic drug, and is teratogenic: women treated with methotrexate should wait three months before trying to conceive again.
Full review (5 pages) available for download by subscribers.

In the February issue of Prescrire International: Localised prostate cancer - immediate treatment, or not?

FREE DOWNLOAD In patients with localised prostate cancer, the principal therapeutic options are: monitoring without initial treatment, prostatectomy and radiotherapy. Results of a comparative randomised trial have provided some useful data for providing information to patients.

Full text available for free download.

Levothyroxine: problems caused by a change in formulation were foreseeable

The specificities of levothyroxine mean that it was foreseeable that a change in formulation would require a careful rebalancing of the treatment for some patients.

Tremors: sometimes drug-induced

Many drugs expose patients to tremors. The appearance or aggravation of tremors should prompt a re-evaluation of the benefits or the dosage of the drugs in question.

The annual Prescrire Awards are given out in Paris: 3 winning drugs, but no "Pilule d'Or"

The independent French medical journal Prescrire announced its Drug Awards for 2017, at its yearly awards ceremony in Paris. One drug made the "Honours List" and two others were recognised as "Noteworthy".

The Prescrire Awards for 2017: one winner for Drug Packaging

The independent French medical journal held its annual awards ceremony in Paris. One Drug Packaging Award was announced, while 3 "Yellow Cards" and some 20 "Red Cards" were handed out for substandard or dangerous packaging.

Prescrire's Information Awards for 2017: 8 drug companies (out of 101 contacted) are honoured for the quality of information provided

Yet again in 2017, most drug companies did not embrace transparency, which is bad news for patients.

Independent French journal Prescrire publishes its annual update of drugs to avoid, in the name of better patient care

In conjunction with the annual Prescrire Drug, Packaging and Information Awards, the nonprofit French medical journal Prescrire has published its annual review identifying drugs that are clearly more harmful than beneficial.

Ataluren (Translarna°) and Duchenne muscular dystrophy. No proof of efficacy and poorly documented harms

FEATURED REVIEW Duchenne muscular dystrophy is a fatal, severely disabling disease that profoundly affects the lives of patients and their carers. But even in this very serious situation, there is no justification for proposing a drug with no proven efficacy beyond a placebo effect, and with poorly documented adverse effects.
Full review (4 pages) available for download by subscribers.

In the January issue of Prescrire International: Primary prevention of cardiovascular disease

FREE DOWNLOAD This month's sample page from the Reviews section makes the point that statins and hypotensive drugs ought not necessarily to be prescribed for everyone who may be at risk.

Full text available for free download.

Drugs to treat rare diseases: abuses spell risks for patients

Poorly evaluated drugs and exorbitant prices, a growing risk for patients.

Drug-induced vocal cord damage

Some drugs induce vocal cord damage.

Medicines: better to evaluate them prior to commercialisation

Drugs are less and less meticulously evaluated before they are commercialised. But post-marketing evaluations are not thorough enough, and this puts patients at risk.

Making rational choices about drug treatment while breast-feeding

FEATURED REVIEW What are the principles for choosing whether and how to treat a nursing woman, without denying her access to useful drugs or harming her breastfed child?
Full review (5 pages) available for download by subscribers.

In the December issue of Prescrire International: valproic acid and pregnancy

FREE DOWNLOAD A recently released study estimates that several thousand children in France who were exposed in utero to valproic acid or one of its derivatives between 1967 and 2016 were affected by at least one major congenital malformation.

Full text available for free download.

Moderate nociceptive pain in adults: first-choice drugs

In patients with moderate nociceptive pain, the first-choice analgesic is paracetamol or, if unsuitable, a NSAID (ibuprofen or naproxen), or else morphine at the lowest effective dose, if necessary.

Induction of labour: information and consent still inadequate

In France, a survey revealed that women are given insufficient information prior to induction of labour, and their consent is often not sought.

Medical abortion in the community setting. The procedures and legal restrictions should be clearly explained to women

FEATURED REVIEW Medical abortion is based on sequential administration of two oral drugs. How effective is medical abortion and what are its adverse effects? How is it undertaken in the community setting in France? We reviewed the available evidence using the standard Prescrire methodology.
Full review (5 pages) available for download by subscribers.

In the November issue of Prescrire International: immunoallergic reactions with nifuroxazide; adverse effects of levothyroxine

FREE DOWNLOAD This month's sample page from the Adverse Effects section demonstrates the wide range of information available every month in Prescrire International.

Full text available for free download.

Type 2 diabetes: intensive therapy can be harmful

It has been established that in patients with type 2 diabetes, intensive hypoglycaemic therapy targeting an HbA1c around 6% leads to excess cardiovascular mortality. It is best to aim for a reasonable target, around 7%.

The sugar lobby's crusade against dental health measures

Lobbying by the sugar industry has undermined the battle against dental caries.

Prescrire's Solidarity Support Programme: facilitating access to quality, independent information

ABOUT PRESCRIRE Prescrire's Solidarity Support Programme helps healthcare professionals and those training to become healthcare professionals to obtain quality, independent information.

The 2017 "Prescrire Prize" is awarded in Paris to
4 noteworthy books about health and healthcare

The recipients of the 2017 "Prescrire Prize" book awards were announced on 5 October 2017. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

• Private patents and public health. Changing intellectual property rules for access to medicines
This book is a recipient of the 2017 Prescrire Prize

Naloxegol (Moventig°) and opioid-induced constipation. Its abdominal adverse effects are probably as troublesome as constipation

FEATURED REVIEW Naloxegol tablets have been authorised in the European Union for adults with troublesome opioid-induced constipation despite laxative therapy. Does naloxegol relieve discomfort in these patients? What are its adverse effects? Does naloxegol reduce the analgesic effect of opioid therapy?
Free summary available here: full review (3 pages) available for download by subscribers.

In the October issue of Prescrire International - Metformin in patients with moderate renal impairment: reduce the dose

FREE DOWNLOAD This month's sample page is taken from the Adverse Effects section. Metformin is the first-choice oral glucose-lowering drug in type 2 diabetes, but it can provoke lactic acidosis, a rare but sometimes fatal adverse effect. What does this mean for patients with moderate renal impairment?
Full text available for free download.

Conflicts of interest in the health sector: hospitals can and must act

It is time for hospitals as well as universities to act to prevent conflicts of interest and to ensure the independence necessary for the best care.

Attention deficit hyperactivity disorder (ADHD): avoid guanfacine

In children diagnosed with attention deficit hyperactivity disorder (ADHD), guanfacine has no proven efficacy in improving family and social relationships. On the other hand, it has frequent, sometimes severe, adverse effects. In practice, it is best to avoid guanfacine.

Lévothyrox° (levothyroxine): a change in formulation results in thousands of reports of adverse effects

In France, the lactose in Lévothyrox° (levothyroxine) tablets was replaced by mannitol and citric acid was added as a preservative. According to France's national medicines agency (ANSM), two pharmacokinetics studies demonstrated that the old and the new tablets were bioequivalent. A pharmacovigilance investigation is underway to look into thousands of reports from patients signalling various disorders following the change in formulation. On 15 September 2017, the Agency made various documents available online.

Statins in secondary cardiovascular prevention

FEATURED REVIEW What is the evidence for the efficacy of statins in secondary cardiovascular prevention? In which situations are they effective? What are their harms? To answer these questions, we reviewed the available evidence using the standard Prescrire methodology.
Free abstract available here; full review (8 pages) available for download by subscribers.

In the September issue of Prescrire International. Levonorgestrel for emergency contraception: after an enzyme inducer, double the dose

FREE DOWNLOAD This month's free sample from the New Products section explores important information to take into account when levonorgestrel is used for emergency contraception.

Full text available for free download.

Vaccination-related errors: analysing errors in order to prevent them

Vaccination errors can have severe consequences, depending on the patient, the vaccine and the type of error. Analysis of the circumstances surrounding such errors is a first step towards preventing them.

French drug agency's recommendations on dosing devices: a step forward

In 2016, the French drug regulatory agency (ANSM) published recommendations for companies regarding dosing devices. These recommendations are welcome, and should be extended.

Healthcare for migrants: rejecting the unacceptable

The 2016 "Prescrire Prize" book awards featured a discussion-debate on the theme: "Healthcare for vulnerable migrants. Taking action to ensure access to high-quality care for everyone". The following excerpts are from the presentation by Arnaud Veïsse, the director of Comede, the French Committee for the Health of Exiles.

Learn more about Prescrire International, an independent, monthly journal written by and for healthcare professionals

ABOUT PRESCRIRE Prescrire International is a monthly journal of selected texts translated from the French journal Prescrire. The editors have put together a free special edition to provide you with a sample of the type of articles you will find in every issue.

Overmedication of society: a concern for all

The independent medical journal Prescrire has published a special section in the August issue of its French edition, examining the role that medicines play in society, in healthcare, and in our lives.

Medicines and culture

A special section in the August issue of the independent French medical journal Prescrire looks at the role medicines play in the relationship between patients and healthcare professionals, and the need to take the symbolic value of medicines into account, as a means to build trust.

"Top Texts of 2017", new from the Editors of Prescrire International

Equine oestrogens + bazedoxifene (Duavive°) and menopause. Inadequately evaluated harms

FEATURED REVIEW A new product combining equine oestrogens and bazedoxifene (Duavive°, Pfizer) has been authorised in the European Union for menopausal disorders in non-hysterectomised postmenopausal women. Past experience suggests that this new combination should be considered with caution, and avoided until these foreseeable adverse effects have been properly evaluated.
Full review (2 pages) available for download by subscribers.

In the July issue of Prescrire International: The adverse effects of the cytotoxic temsirolimus and the opioid pholcodine

FREE DOWNLOAD In the Adverse Effects section of this issue, the cardiac risks of the cytotoxic immunosuppressant temsirolimus, used in metastatic renal cell carcinoma and mantle cell lymphoma, and the harms caused by the opioid pholcodine, still present in many cough suppressants.

Full text available for free download.

Pertuzumab: of variable benefit depending on the type of breast cancer

In some patients with metastatic breast cancer, pertuzumab in combination with trastuzumab + docetaxel is proven to extend life, but at the cost of increased cardiac adverse effects. There is no evidence that this drug is beneficial as a neoadjuvant treatment when the breast cancer has not metastasised.

Pregnancy and Graves' disease: opt for treatments posing the lowest maternal and fetal risks

Treatment of pregnant women with Graves' disease (hyperthyroidism) is problematic since all drug therapies carry significant risks. Some synthetic antithyroid drugs are the treatment of choice.

Who are we? A non-profit continuing education organisation, committed to better patient care

ABOUT PRESCRIRE Prescrire and Prescrire International provide independent information, by and for healthcare professionals. Since 1981, Prescrire has provided healthcare professionals – and via them, patients – with the clear, comprehensive and reliable information they need about drugs and therapeutic and diagnostic strategies.

Global "No Free Lunch" Conference in Berlin 15-17 September 2017: "How do conflicts of interest harm health around the world?"

The conference will bring together experts and activists from countries around the world, including Australia, Brazil, Chile, France, Germany, India and South Africa.

Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya°) and HIV

FEATURED REVIEW First-line therapy for human immunodeficiency virus (HIV) infection is based on a combination of at least three antiretroviral drugs. A formulation of tenofovir, tenofovir alafenamide, was authorised in the EU in late 2015 as part of a fixed-dose combination containing emtricitabine + elvitegravir + cobicistat (Genvoya°). This four-drug fixed-dose combination does not represent a therapeutic advance over other antiretroviral combinations.
Full review (2 pages) available for download by subscribers.

In the June issue of Prescrire International: Prescrire's finances

FREE DOWNLOAD Prescrire and Prescrire International are published by a non-profit association which makes its accounts freely available every year, in the name of transparency.

Full report available for free download.

Hypertension and diabetes: if chlortalidone is unavailable, an ACE inhibitor should be the drug of choice

Hypertension treatment in diabetes patients aims to reduce the risk of complications: cardiovascular events, end-stage renal failure, deterioration of eyesight.

Compensate victims!

Victims of highly publicised drug scandals are promised compensation, while victims of adverse reactions to other medications struggle to take the manufacturers to court, to gain media coverage, and to get politicians' attention.

2016 drug packaging review: too much focus on marketing rather than patient safety

Drug packaging (packets, vials, patient leaflets, etc.) is important for the proper use of medicines and the prevention of adverse effects. Drug regulatory agencies do not place enough emphasis on patient protection

Wholly self-financed through subscriptions, Prescrire makes its accounts public every year

"Preventing Overdiagnosis 2017: Towards Responsible Global Solutions": an international conference in Quebec City,
17-19 August 2017

The not-for-profit group "Preventing Overdiagnosis", dedicated to "winding back the harms of too much medicine", has announced plans for its 2017 conference.

Pharmaceutical research and development: a new system is needed

FEATURED REVIEW The system for stimulating pharmaceutical research and development (R&D) is increasingly showing serious limitations. The new drugs it produces are unaffordable and often offer only minor or even no benefits to patients. A number of interesting proposals have been put forward to remedy the flaws in the current system or to establish alternative systems.
Full review (6 pages) available for download by subscribers.

In the May issue of Prescrire International - The year in review: New drugs and new indications in 2016

FREE DOWNLOAD Each month, Prescrire publishes its independent, methodical, systematic reviews, analysing new drugs, new indications for drugs already on the market, and existing drugs authorised in a new pharmaceutical form or at a new dose strength. In 2016, Prescrire’s Editorial Staff analysed the clinical evaluation data for 92 drugs.

Full text available for free download.

Prescrire's ratings: new products and indications over the last 10 years

Diabetes: avoid insulin degludec in combination with liraglutide

In patients with type 2 diabetes, the combination of insulin degludec and liraglutide in an injection pen has more disadvantages than advantages.

Excessive hair growth: certain drugs implicated

Some drugs expose patients to excessive hair growth, which is usually reversible when treatment is discontinued.

Venous thromboses: coagulation disorder testing rarely beneficial

Awareness of the presence of an acquired or hereditary coagulation abnormality is useful for the management of a thromboembolic event only in certain cases.

How a review in Prescrire is produced

ABOUT PRESCRIRE Prescrire's reviews, written by specially trained healthcare professionals, are based on an exhaustive search of the literature, and undergo scrutiny by a large panel of outside reviewers plus rigorous quality control procedures.

A conference entitled "Does Industry Influence Medical Discourse?" will be held in Washington, D.C. on 15-16 June 2017

Organised by the non-profit group PharmedOut, the conference will include discussions on "The Future of Drug Regulation", "Pharma's Relationships with Patient Advocacy Groups" and a variety of related topics.

Cancer drug pricing: deciphering the leaked e-mails

NEWS FLASH A group of hackers specialised in investigating the pharmaceutical industry has obtained thousands of e-mails in which major pharmaceutical companies discuss their methods for setting drug prices. Prescrire has gained access to the leaked documents...

• Decline in vigilance: leaked information is everywhere, but does it hold water?

Look before you trust a leak! All too often, the revelations of shadowy "hackers" get more credence than the plain old facts that are right in front of our noses. All those thousands of "leaked e-mails" referred to in our April 1 "News Flash" deliver a serious message about our less-than-water-tight perception of information.

Delamanid (Deltyba°) and multidrug-resistant pulmonary tuberculosis. For selected patients, with cardiac monitoring

FEATURED REVIEW Despite delamanid's rather shaky evaluation, the available data suggest that this antibiotic should be offered to patients with multidrug-resistant tuberculosis. The noteworthy impact of delamanid on the QT interval warrants electrocardiographic monitoring and close attention to drug interactions.
Full review (4 pages) available for download by subscribers.

In the April issue of Prescrire International: unborn children still exposed to NSAIDs

FREE DOWNLOAD In the Adverse Effects section of the April edition: results of a French study showing that around 5% of unborn children in France are exposed to prescribed NSAIDs, including about 1% from the 6th month of pregnancy. And these numbers exclude self-medication. Authorities need to send out a stronger message: "NEVER USE NSAIDs DURING PREGNANCY".

Full text available for free download.

Protelos° (strontium ranelate) ought to have been withdrawn from the market long ago

In early March 2017, drug company Servier announced that it would be withdrawing its strontium ranelate-based Protelos° from the market. This withdrawal comes after far too much foot-dragging, which was positive for the company but harmful for patients. Considering its efficacy, modest at best, and its disproportionate adverse effects, strontium ranelate ought to have been withdrawn from the market long ago.

Knowing how to say "No thank you" is crucial

Being able to say "no thank you" to firms seeking to influence healthcare professionals is crucial to obtaining information and training that prioritises patients’ best interests. It is also crucial when choosing a drug, especially when that drug does more harm than good and exposes patients to disproportionate risks.

Bone fragility: preventing fractures

The prevention of fractures associated with bone fragility is based on fall prevention and regular physical activity, and drug therapy only in some cases.

Prescrire's "Non merci" Charter: saying "No thank you" to conflicts of interest

ABOUT PRESCRIRE Prescrire's pioneering "Non merci..." Charter guarantees that Prescrire's editors and managers are free from any conflicts of interest.

Graves' disease in adults. Antithyroid drugs, radioactive iodine, or sometimes thyroidectomy

FEATURED REVIEW Graves' disease is the most frequent cause of hyperthyroidism. What is the best treatment for adults with Graves' disease? To answer this question, we reviewed the literature using the standard Prescrire methodology.
Full review (6 pages) available for download by subscribers.

In the March issue of Prescrire International: The Prescrire Awards for 2016

FREE DOWNLOAD The annual Prescrire Awards for Drugs, Drug Packaging and Information were announced in Paris by the independent French medical journal.

Full text available for free download.

Could "Brexit" spell greater independence for the European Medicines Agency?

Leaving its current base in London could prompt the EMA to distance itself from financial interests, and focus on important patient interests instead.

Drug-related diarrhoea: pre-empt risks

Many drugs expose patients to sometimes severe diarrhoea, through various mechanisms.

Prescrire's ratings: new drugs and indications, at a glance

ABOUT PRESCRIRE Each month, Prescrire's editors review new drugs and new indications, to assess whether or not they represent a therapeutic advance for patients. Our unique ratings system sums up this detailed, evidence-based opinion at a glance.

Towards better patient care: drugs to avoid in 2017

In conjunction with the annual Prescrire Drug, Packaging and Information Awards, the nonprofit French medical journal Prescrire has published its updated list of drugs to avoid. This annual review identifies drugs that are clearly more harmful than beneficial.

Prescrire's Drug Awards for 2016 recognise two cancer drugs

Independent French medical journal Prescrire announced its Drug Awards in Paris on 26 January 2017. There were no additions to the "Honours List" and no "Pilule d'Or" ("Golden Pill") awarded this year, but two cancer drugs were deemed "Noteworthy".

Prescrire's Drug Packaging Awards for 2016: no award, but serious deficiencies

The independent French medical journal Prescrire announced its drug Packaging Awards on 26 January 2017. The low standards to which regulators hold pharmaceutical companies with regard to this important aspect of the quality of healthcare are disturbing, because they jeopardise patients' safety.

Prescrire's Information Awards for 2016: several drug companies are honoured, but the lack of transparency persists

The 2016 Information Awards by non-profit French medical journal Prescrire reveal that, as in previous years, few pharmaceutical companies embraced transparency by agreeing to share all the data they hold with healthcare professionals

Sacubitril + valsartan (Entresto°) in chronic heart failure. Favourable results in highly selected patients

FEATURED REVIEW Replacing an ACE inhibitor or an ARB with the high-dose sacubitril + valsartan combination should be envisaged with care, and solely for heart failure patients comparable to those included in the only available trial. Most chronic heart failure patients should continue to use better-assessed medications.
Full review (5 pages) available for download by subscribers.

In the February issue of Prescrire International: Idebenone (Raxone°) and Leber hereditary optic neuropathy

FREE DOWNLOAD In this month's sample page: regulatory agencies are sometimes satisfied with data that do not come from true comparative trials. The case of idebenone in Leber hereditary optic neuropathy is particularly shocking.

Full text available for free download.

Neuroleptics: too readily prescribed

So-called second-generation neuroleptic drugs are not as harmless as drug companies made them out to be.

A fresh, new look for Prescrire International

The monthly journal Prescrire International has been completely redesigned, to better serve the needs of healthcare professionals. The page layout is clearer, and key information is signposted, making it easier to incorporate into daily practice, all in the name of better patient care.

Drug regulatory agency moves to suspend sales of French vitamin D supplement Uvestérol°, following the death of an infant

Prescrire welcomes the move by France's health products agency (ANSM) to suspend sales of the French vitamin D supplement Uvestérol° D. This decision should have been made years ago, especially as there are other forms of vitamin D that are less complicated to administer and less risky.

RTS,S/AS01E malaria vaccine (Mosquirix°). Children living in malaria-endemic regions: little efficacy, poorly documented harms

FEATURED REVIEW In late 2016, the harm-benefit balance of the RTS,S/AS01E malaria vaccine is highly uncertain, but its evaluation must continue where the vaccine is much needed.
Full review (4 pages) available for download by subscribers.

In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir

FREE DOWNLOAD In the "Adverse Effects" section of this month's issue, ischaemic colitis with the decongestant pseudoephedrine, and a risk of pulmonary arterial hypertension with the hepatitis C drug sofosbuvir.

Full text available for free download.

Advanced ovarian cancers: olaparib negatively impacts the quality of life, without prolonging survival

According to the current, very limited knowledge, the harm-benefit balance of olaparib is unfavourable for patients in remission from ovarian cancer treated with chemotherapy.

Cholesterol: slightly higher risk of type 2 diabetes with all statins

Several large-scale studies have revealed an increased risk of type 2 diabetes in patients taking a statin.

Hypertension: delicate choice of blood pressure target

Aiming for blood pressure of 120 mm Hg presents advantages and risks, and should be discussed with some patients.

Diethylstilbestrol (DES): also harms the third generation

FEATURED REVIEW Diethylstilbestrol (DES) is a synthetic nonsteroidal oestrogen and endocrine disruptor that was used in the 1950s-1970s to prevent spontaneous abortion, despite its lack of proven efficacy. In utero exposure to DES can have harmful effects. What are the consequences of taking DES during pregnancy for the third generation, i.e. the children of DES children?
Full review (5 pages) available for download by subscribers.

In the December issue of Prescrire International: Cobimetinib (Cotellic°) and metastatic melanoma

FREE DOWNLOAD Clinical evaluation of cobimetinib in patients with metastatic or inoperable melanoma positive for the BRAF V600 mutation confirms that frontline treatment with a MEK kinase inhibitor plus a BRAF inhibitor prolongs survival by a few months, at a cost of many potentially serious adverse effects.

Full text available for free download.

Metastasised or non-operable melanomas: progress

In patients suffering from a metastasised or inoperable melanoma with or without a genetic mutation, new antitumor drugs are making it possible to prolong life for several months, at the price however of sometimes severe adverse effects.

Operable lung cancer: chemotherapy, an option to be discussed with informed patients

In patients with non-small-cell lung cancer at an advanced but operable stage, anticancer platinum salts chemotherapy slightly prolongs life, but at the cost of many severe adverse effects.

From the editors of Prescrire International: Top texts of 2015-2016

FREE SPECIAL EDITIONCheck out this sampling of texts, selected by Prescrire's editors to introduce you to this wholly independent monthly journal, written by and for healthcare professionals

Human papillomavirus vaccines and Guillain-Barré syndrome: managing uncertainties

FEATURED REVIEW Several reports of autoimmune disorders following HPV vaccination have been published, although the cause-effect relationship is uncertain. Do the detailed results of a large French study, published in late 2015, alter the harm-benefit balance of HPV vaccines?
Full review (6 pages) available for download by subscribers.

In the November issue of Prescrire International: More on domperidone and sudden cardiac death. French opinion leaders and regulators in the hot seat

FREE DOWNLOAD In a letter to Prescrire's editors, the lead author of a study on the number of deaths attributable to domperidone answers critiques that appeared in the French news media after the publication of the study.

Full text available for free download.

Chronic obstructive pulmonary disease (COPD): smoking cessation and appropriate medication

Drug treatments for COPD are effective chiefly against the symptoms and should be adjusted according to the progression of the disease.

Anticoagulant: the "antidote" to dabigatran (Pradaxa°) is insufficiently evaluated

The effects of idarucizumab (Praxbind°) have not been sufficiently evaluated: its effect against the risk of bleeding is not proven. Its authorisation as an antidote should not encourage the wider use of dabigatran.

The 2016 "Prescrire Prize" is awarded in Paris to
3 noteworthy books about health and healthcare

The recipients of the 2016 "Prescrire Prize" book awards were announced on 6 October 2016. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Caring for vulnerable migrants. Acting to ensure access to quality care for all. A discussion-debate (in French) organised by Prescrire in Paris

VIDEO Migrants, refugees: women, children and men, often in a situation of extreme vulnerability. How can they be provided with the healthcare they need, on both an emergency and a longer-term basis? A discussion-debate in French on this important topic was organised by Prescrire in Paris on 6 October.

Metoclopramide, domperidone: sudden cardiac death, ventricular arrhythmia

FEATURED REVIEWThe neuroleptics metoclopramide and domperidone have been used since the 1960s and the 1980s respectively for nausea and vomiting. Their limited efficacy and the severity of their adverse effects have slowly come to light over time. Results published in 2015 confirmed and quantified the risks of serious arrhythmia and sudden cardiac death with both drugs.
Full review (3 pages) available for download by subscribers.

In the October issue of Prescrire International: Prucalopride (Resolor°) and chronic constipation in men

FREE DOWNLOAD For men presenting with constipation, a troublesome but usually benign disorder, prucalopride carries a disproportionate risk of cardiovascular disorders, depression and suicidal ideation. As in women, it is better to optimise the use of standard laxatives, and to avoid prucalopride altogether.

Full text available for free download.

Falls in the elderly: proven benefits of exercise

Following on from others, a new trial has shown the benefits of exercise in preventing falls with trauma in elderly women.

MedDRA and pharmacovigilance: a complex and little-evaluated tool

The standardised "Medical Dictionary for Regulatory Activities" (MedDRA) is used for coding adverse effects in clinical study reports and pharmacovigilance databases. Its complexity and its poorly evaluated performance make it susceptible to manipulation, errors of interpretation and bias.

Evolocumab (Repatha°). A "mab" for hypercholesterolaemia: no evidence of benefits

FEATURED REVIEW In adults with hypercholesterolaemia, evolocumab has only been evaluated in terms of surrogate (i.e. non-clinical) endpoints. In addition, its long-term adverse effects are poorly documented, even though evolocumab is intended for long-term administration.
Full review (5 pages) available for download by subscribers.

In the September issue of Prescrire International: adverse effects of mizolastine, dextromethorphan, desloratadine and loratadine

FREE DOWNLOAD This sample page from the September edition contains three brief reviews analysing the adverse effects of several frequently prescribed antihistamines and antitussive medicines.

Full text available for free download.

Citalopram and escitalopram: opt for other SSRI antidepressants

As of early 2016, studies point to the same overall conclusion: that citalopram and its derivative escitalopram expose patients to a higher risk of cardiac disorders than other SSRI antidepressants.

Council of Europe: put patients' health before that of drug companies

The Council of Europe defends the primacy of public health over industrial interests.

Tendinopathy: possibly drug related

Knowing which drugs and factors can cause tendinopathy makes it possible to identify them rapidly and avoid them.

"Adaptive pathways": EMA's dangerous plan

The "adaptive pathways" proposed by the European Medicines Agency (EMA) aim to shorten the process for bringing drugs onto the market. This could lead to a situation in which marketing authorisations granted on the basis of very limited evaluation become the norm.

Healthcare professionals: building relationships for quality care

The special summer issue of the independent French medical journal La revue Prescrire offers subscribers a "ramble" in search of better care: mapping out one's practice, moving forward safely, enlarging one's field of vision.

Healthcare that is adapted to each patient

With knowledge brought fully up to date via rigorous and independent continuing medical education, healthcare professionals can then take each patient's situation into account, to share decision-making with them.

For better patient care: take a critical approach, and keep an open mind

For quality patient care, healthcare professionals must maintain a critical approach towards the information that they come across. This healthy skepticism also makes it easier to strike compromises with patients, in their best interest.

Progestogens and prevention of preterm birth in women at risk

FEATURED REVIEW How effective are the natural hormone progesterone and the progesterone derivative hydroxyprogesterone in preventing preterm birth in women at high risk? And what are the adverse effects on the mother and the unborn child?
Full review (4 pages) available for download by subscribers.

In the July issue of Prescrire International - Adalimumab (Humira°) and plaque psoriasis in children: no better than other immunosuppressants

FREE DOWNLOAD In a trial in 114 children, the efficacy of adalimumab was not notably different from that of methotrexate, and its adverse effects profile did not appear to be more favourable.

Full text available for free download.

Tuberculosis and AIDS: major progress

AIDS and tuberculosis still rank among the leading causes of death worldwide. But large-scale access to treatments has enabled a marked reduction in TB- and AIDS-related deaths in the last 15 years.

Electronic prescribing: risk of potentially harmful errors

Electronic prescribing is supposed to improve the various stages of medication use. But it can also result in potentially harmful errors. Healthcare professionals have a crucial monitoring role to play.

Student associations drive pharmaceutical companies off campus

Pharmaceutical companies seek to influence healthcare professionals beginning when they are students. Students in several countries are taking action to highlight and avoid these influences.

Empagliflozin (Jardiance°) in type 2 diabetes: no rush to use this drug

FEATURED REVIEW There is no evidence that empagliflozin has a favourable harm-benefit balance when used for prevention of the cardiovascular complications of type 2 diabetes. More trial data are needed on the harm-benefit balance of empagliflozin compared to other cardiovascular therapies.
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International: decongestants during pregnancy - risks for the unborn child

FREE DOWNLOAD Sympathomimetic decongestants provoke serious, albeit rare, adverse effects. In the second and third trimesters of pregnancy, the fetus is exposed to the same adverse effects as the mother. These drugs should quite simply never be used, including via the nasal route.

Full text available for free download.

Prescrire: 100% financed by subcribers

Prescrire, financed solely through subscriptions, with no revenues from advertising or grants, publishes its accounts each year.

2015 drug packaging review: drug companies and insufficient regulation are putting patients at risk

Pharmaceutical companies are fully aware of the solutions for ensuring the quality and safety of drug packaging. But too much drug packaging remains unsafe and too many package leaflets are inadequate.

The drug pricing racket

The extortionate prices of some new drugs supposedly reflect their "value" for patients and for society. This argument does not hold water.

Remembering Andrew Herxheimer

A long-time friend and colleague and a source of inspiration for Prescrire, Andrew Herxheimer passed away on 21 February 2016 at the age of 90. Prescrire was greatly enriched by Andrew’s ideas, vision, enthusiasm and experience.

Hepatitis C treatment with dasabuvir (Exviera°) and the ombitasvir + paritaprevir + ritonavir combination (Viekirax°): await further trials

FEATURED REVIEWS The combination of dasabuvir with ombitasvir + ritonavir-boosted paritaprevir yields a sustained virological response in nearly every patient with genotype 1 hepatitis C virus infection. However there is no evidence that its harm-benefit balance is better than that of the ledipasvir + sofosbuvir combination, and there are many unknowns in terms of adverse effects and interactions.
Full reviews (4 pages and 2 pages) available for download by subscribers.

In the May issue of Prescrire International: Ranibizumab or bevacizumab in AMD?

FREE DOWNLOAD The Italian independent drug bulletin Informazioni sui Farmaci published a review comparing ranibizumab versus bevacizumab for age-related macular degeneration (AMD). Its conclusion differs from that of Prescrire’s review. A letter from Informazioni sui Farmaci's editors and Prescrire's reply explore the various scientific and policy questions surrounding these treatments.

Full text available for free download.

Hypertension: avoid olmesartan pending its withdrawal

Olmesartan exposes patients to increased, and sometimes severe, gastrointestinal adverse effects. It is in the best interest of patients not to use it.

New drugs and indications in 2015: little progress, despite exorbitant prices

Prescrire's report on drugs evaluated during 2015 highlights abuse of the orphan drug policy.

Drug-related hair loss: not only anti-cancer medication

Hair loss can sometimes have a profound psychological impact. It is linked to a wide range of causes, including medication, and not only anti-cancer drugs.

Heavy lobbying by pharmaceutical companies in Europe

Each year, pharmaceutical companies spend tens of millions of euros on lobbying EU institutions, and have dozens of lobbyists working on their behalf.

Towards better patient care: drugs to avoid in 2016

FEATURED REVIEW Announced in conjunction with the annual Prescrire Awards and published in the April issue of Prescrire International, the 2016 update of Prescrire's list of drugs to avoid includes 74 drugs that are more harmful than beneficial in all of the indications for which they are authorised in France. Notable changes this year include the addition of the widely prescribed drugs citalopram, escitalopram and diclofenac amongst the drugs to avoid.
Full review (7 pages) available for free download.

In the April issue of Prescrire International: adverse effects of SSRIs, gliptins and mirabegron

FREE DOWNLOAD In this sample page from the Adverse Effects section of the April issue: extrapyramidal reactions with certain antidepressants, joint pain with gliptins and the cardiovascular effects of incontinence drug mirabegron.
Full text available for free download.

Venlafaxine: unjustifiable cardiovascular risks

There is considerable evidence that venlafaxine carries an increased risk of adverse cardiovascular effects and of overdose deaths, compared with most other "selective" serotonin reuptake inhibitors (SSRIs), whereas the efficacy of all SSRIs is similar – and limited.

Allergic rhinitis during pregnancy: opt for the lowest risk

When drug treatment for allergic rhinitis is recommended in a pregnant woman, there are various options that expose the patient to few risks: sodium cromoglicate or azelastine nasal inhaler or an oral or nasal non-sedating and non-antimuscarinic antihistamine.

International nonproprietary names: more informative

The goal of a drug's International nonproprietary name (INN) is to provide information about the drug's mechanism of action or pharmacotherapeutic group. A far cry from brand names, which are designed to facilitate sales.

"Speed Care": an innovative new programme in France aims to help doctors and pharmacists save precious time

NEWS FLASHDateline Paris, 1 April 2016. A new continuing medical education programme in France entitled "Speed Care" allows healthcare professionals to better manage their increasingly precious time. One example of the promising new techniques is a weekly schedule organised according to patients’ conditions, to achieve an "optimisation of available physician brain-time".

• Decline in vigilance: not so fast!

Like the rabbit in "Alice in Wonderland", the hurrier we go, the behinder we get. And the more bewildered we become. We all need an annual April "booster shot", to help us all take a long, leisurely look at our perception of information.

Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use

FEATURED REVIEW Endogenous Cushing's syndrome is a rare but serious disease. Ketoconazole was effective in over 50% of cases in non-comparative series in a total of 800 patients. However, ketoconazole is hepatotoxic and interacts with many other drugs.
Full review (2 pages) available for download by subscribers.

In the March issue of Prescrire International: drug-induced angioedema

FREE DOWNLOAD Angioedema is a localised oedema of the skin or mucous membranes, typically affecting the face, lips, tongue, throat, ears, hands, feet and external genital organs. This sample page from the "Adverse Effects" section of the March issue contains three short texts on causes and mechanisms of drug-induced angioedema.

Full text available for free download.

Chronic obstructive pulmonary disease: benefits of exercise

Physical exercise improves the quality of life for patients suffering from chronic obstructive pulmonary disease. The adverse effects have yet to be fully evaluated.

BCG vaccine SSI°: too many errors

The poorly designed packaging of the tuberculosis immunisation BCG vaccine SSI° exposes patients to errors, serious overdoses in particular.

Pesticides: a toxic issue

Pesticides have a lot in common with pharmaceuticals: poorly evaluated or exaggerated efficacy, products marketed without sufficient knowledge of the risks, research financed by the manufacturers.

Drugs to avoid in the name of better patient care: 2016 update

In conjunction with its annual Prescrire Awards, the independent French medical journal Prescrire has updated its list of drugs to avoid. The goal is to help healthcare professionals and patients choose high-quality treatments that minimize the risk of adverse effects.

Prescrire's Drug Awards for 2015 honour new indications for three older drugs

Independent French medical journal Prescrire held its annual Drug Awards in Paris on 28 January 2016. One drug was added to the "Honours List" and two others deemed "Noteworthy", but there was no "Pilule d'Or" ("Golden Pill") awarded this year.

Prescrire's Drug Packaging Awards for 2015: still too many dangerous flaws

The annual Packaging Awards by independent French medical journal Prescrire demonstrate that, while solutions do exist, there are still far too many examples of dangerous drug packaging and incomplete patient leaflets.

Prescrire's Information Awards for 2015: a handful of drug companies are honoured, amidst a general lack of transparency

A company's transparency, part and parcel of its credibility, is an essential component of drug safety. The 2015 Information Awards by non-profit French medical journal Prescrire reveal another year marked by a lack of transparency on the part of drug companies.

"Adaptive licensing": the European Medicines Agency's unwise proposals. A discussion-debate at the annual Prescrire Awards

Speeding up patients' access to new drugs only makes sense if those drugs have an acceptable, and adequately studied, harm-benefit balance. On 28 January 2016 the non-profit French medical journal Prescrire held its annual awards ceremony, with a discussion-debate on "adaptive pathways" for marketing authorisations, as proposed by the European Medicines Agency.

In the February issue of Prescrire International. Oseltamivir (Tamiflu°): over 15 years of data retention and systematic stonewalling

FREE DOWNLOAD Oseltamivir was authorised in the EU in 2002 for the prevention and treatment of influenza. Despite widespread belief in its efficacy, cleverly orchestrated by the drug's manufacturer and other organisations, a number of independent teams were not convinced and went on a hunt for missing data. They discovered that the available trial results were neither complete nor clinically relevant and provided only weak evidence.

Full text available for free download.

"Weak" opioid analgesics: codeine, dihydrocodeine and tramadol are no less risky than morphine

FEATURED REVIEW When opioid therapy is needed, there is no evidence that codeine, dihydrocodeine or tramadol is less risky than morphine at its lowest effective dose. The efficacy of these drugs varies more from one patient to another, and their multiple pharmacokinetic interactions can be difficult to manage. Weak opioids require at least as much vigilance as morphine, despite the major differences in their reputation and regulation.
Full review (7 pages) available for download by subscribers.

"Preventing Overdiagnosis": an international conference to be held in Barcelona on 20-22 September 2016

The not-for-profit group "Preventing Overdiagnosis", dedicated to "winding back the harms of too much medicine", has announced plans for its 2016 conference.

Liraglutide (Saxenda°) and obesity: there are still no satisfactory weight loss drugs

FEATURED REVIEW On average, daily liraglutide injections for one year help patients lose only a few kilograms compared with placebo, and weight is gradually regained after treatment discontinuation. Patients who are overweight or obese should not be exposed to the frequent gastrointestinal disorders and the risk of pancreatitis associated with long-term, high-dose liraglutide therapy.
Full review (4 pages) available for download by subscribers.

In the January issue of Prescrire International: gestodene + ethinylestradiol (Apleek°). No place for a patch containing a third-generation progestin

FREE DOWNLOAD Delivering the gestodene and ethinylestradiol combination via fancy transparent patches in no way avoids exposing women to the higher thrombotic risk associated with third-generation progestin contraceptives.

Full text available for free download.

Nonsteroidal anti-inflammatory drugs (NSAIDs): avoid cox-2 inhibitors, diclofenac and high-dose ibuprofen

When pain medication is required, paracetamol (alias acetaminophen) is the reference drug. Among the nonsteroidal anti-inflammatories (NSAIDs), naproxen or ibuprofen (not exceeding 1200 mg a day) are the drugs that carry the least exposure to cardiac disorders.

Menopausal hormone therapy: in addition to other risks, an increased risk of ovarian cancer

The harm-benefit balance for hormone replacement therapy in menopause is unfavourable due to an increased risk of cardiovascular disease and of breast cancer. It also exposes women to ovarian cancer.

Helicobacter pylori and gastric or duodenal ulcer: treatment

In 2015, for cases of gastric or duodenal ulcer with proven Helicobacter pylori infection, the evaluation data indicate a probabilistic treatment with three antibiotics rather than two.

"Adaptive licensing": the European Medicines Agency's unwise proposals

Under the guise of speeding up access to new drugs, the European Medicines Agency is planning to carve up the marketing authorisation process, compromising the pre-marketing evaluation of new drugs, especially the evaluation of harms. A discussion-debate (in French) on this topic will be organised by independent medical journal Prescrire on Thursday 28 January 2016, from 9.45am on, at the Espace Saint-Martin in Paris.

Ledipasvir + sofosbuvir (Harvoni°): a therapeutic advance in genotype 1 hepatitis C virus infection, despite uncertainties

FEATURED REVIEW In seven trials including over 3000 patients with chronic HCV genotype 1 infection, the ledipasvir + sofosbuvir combination yielded a sustained virological response in nearly every case, while avoiding the use of peginterferon alfa and ribavirin, two drugs with numerous adverse effects and constraints. The adverse effects of the ledipasvir + sofosbuvir combination are still poorly assessed, calling for rigorous pharmacovigilance.
Full review (5 pages) available for download by subscribers.

In the December issue of Prescrire International: misoprostol vaginal insert (Misodel°)

FREE DOWNLOAD In this sample page from the New Products section of the December issue: misoprostol vaginal insert (Misodel°) is riskier than dinoprostone for inducing labour.

Full text available for free download.

Smoking cessation with nicotine replacement products: cardiac adverse effects, often benign

When drug treatment is deemed necessary to assist smoking cessation, nicotine replacement products are the first-line drugs. They expose patients to benign palpitations but not to severe cardiovascular harms.

Depression: rule out agomelatine

At the beginning of 2015, the European health authorities decided to allow agomelatine to remain on the market, subject to producing a patient follow-up booklet. A palliative measure to enable this drug to remain on the market, whereas it is better to rule it out altogether.

Gastro-oesophageal reflux and pregnancy: various treatment options

Non-drug measures can often make the symptoms of gastro-oesophageal reflux during pregnancy acceptable to patients. The reference drugs are the same both during and outside pregnancy.

E-cigarettes: similar efficacy to other nicotine delivery devices, but many uncertainties

FEATURED REVIEW How effective are e-cigarettes as an aid to smoking cessation, and what are their known adverse effects? To answer these questions, we conducted a review of the literature using the standard Prescrire methodology.
Full review (6 pages) available for download by subscribers.

In the November issue of Prescrire International - Ivabradine: European authorities have instituted precautionary measures, but stopped short of withdrawing this drug

FREE DOWNLOADIvabradine offers no advantages over other options and is known to have sometimes fatal cardiovascular adverse effects. Since European health authorities have not yet decided to withdraw this drug from the market, it is advisable to simply avoid it.

Full text available for free download.

Pharmacovigilance: don't rely on pharmaceutical companies

Various scandals have shown that pharmaceutical companies sometimes hush up data on adverse effects. And these scandals are not one-offs, as a US study shows.

Atypical neuroleptics: renal failure in elderly patients

In addition to their many known adverse effects, neuroleptics expose elderly patients to renal failure.

Pharmacovigilance: the contribution of France's regional centres

France's annual event "Les journées françaises de pharmacovigilance" allows a glimpse into the adverse effects reports gathered by the country's regional pharmacovigilance centres, and into the country's national database of pharmacovigilance information. Information that is useful for improving patient care.

The 2015 "Prescrire Prize" is awarded in Paris to
5 noteworthy books about health and healthcare

The recipients of the 2015 "Prescrire Prize" book awards were announced on 1 October 2015. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Naltrexone + bupropion (Mysimba°): too risky for only modest weight loss

FEATURED REVIEW On average, obese or overweight patients taking naltrexone + bupropion lose only a few kilograms. In contrast, its neuropsychiatric adverse effects are numerous and potentially severe. There is also a risk of hypertension, cardiac arrhythmia and gastrointestinal adverse effects.
Full review (4 pages) available for download by subscribers.

In the October issue of Prescrire International: Regorafenib (Stivarga°) and gastrointestinal stromal tumours after treatment failure

FREE DOWNLOAD In this sample page from the New Products section: regorafenib has no proven impact on overall survival for patients with unresectable or metastatic gastrointestinal stromal tumours in whom imatinib and sunitinib have failed.

Full text available for free download.

Cancers treated in childhood: long-term adverse effects

People treated for a cancer in childhood are exposed to adverse effects occurring years later, and should be monitored appropriately.

Drugs: exorbitant prices harm research

Inflated prices are not a sufficient incentive for drug research that is in the public interest, but conversely can be counter-productive.

Hypothyroidism in adults: treat patients exhibiting symptoms

Monitoring without treatment is an option in the case of a moderately high TSH levels with no clear clinical manifestations.

In the wake of France's Mediator° (benfluorex) disaster, a "manifesto" in favour of medical ethics

30 physicians, philosophers and activists have launched "Le Manifeste des 30", a manifesto to remind the drug company Servier and the medical profession of their legal and moral obligations.

Drug-induced lesions of the oesophageal mucosa

FEATURED REVIEW Drugs provoke oesophageal lesions through a variety of mechanisms. Which drugs expose patients to the risk of oesophageal mucosal lesions?
Full review (4 pages) available for download by subscribers.

In the September issue of Prescrire International:
Aflibercept (Eylea°) and diabetic macular oedema

FREE DOWNLOADAflibercept (Eylea°), a VEGF inhibitor, is authorised for intravitreal administration in the treatment of diabetic macular oedema. How does it compare to other VEGF inhibitors in this setting?

Full text available for free download.

Age-related macular degeneration: do not take risks in order to cut costs

In the best interests of patients suffering from age-related macular degeneration (AMD), it is better to prescribe ranibizumab, despite its inflated price, which must be challenged and reduced, as opposed to bevacizumab.

Type 2 diabetes: Mediterranean diet helps delay drug treatment

A trial has shown that if patients suffering from recently discovered type 2 diabetes switch to a Mediterranean diet, this appears to delay the need for treatment with glucose lowering drugs as opposed to a low-fat diet.

Drugs sold cheaply to hospitals push up prices in pharmacies

Hospital prescriptions have a major impact on prescriptions in the community. Pharmaceutical companies sell some drugs cheaply to hospitals in order to increase sales in pharmacies.

French non-profit medical journal Prescrire devotes its special summer edition to "Therapeutic advances that benefit patients"

Genuine therapeutic advances are few and far between, and they can be difficult to spot. The independent journal Prescrire helps to single them out.

Therapeutic advance: orienting research for the benefit of patients

Pharmaceutical research is oriented towards the most profitable markets. Most of the clinical trials financed by drug companies do not allow for the best therapeutic choices to be made. In its special edition devoted to "Therapeutic advances that benefit patients", the French non-profit journal Prescrire calls for a reorientation of research.

Making drugs more convenient to use: progress that often goes unnoticed

Convenience, in other words the ease and safety of use, is a factor in a drug's harm-benefit balance. This important source of therapeutic progress is examined in the special issue of non-profit French journal Prescrire devoted to "Therapeutic advances that benefit patients".

Decisive advances for patients: achieved over time

Therapeutic advances both great and small, for many patients or for just a few, have accumulated over the past several decades. In a special summer edition, the French non-profit journal Prescrire sums up the "Therapeutic advances that benefit patients".

Propranolol (Hemangiol°): the drug of first choice for severe infantile haemangiomas

FEATURED REVIEW Haemangiomas are benign vascular tumours that generally arise in the skin during the first days of life. When an infant requires medical treatment for haemangioma, oral propranolol is the drug of first choice.
Full review (3 pages) available for download by subscribers.

In the July issue of Prescrire International: adverse effects of galantamine, topiramate and cotrimoxazole

FREE DOWNLOAD All in one sample page: from serious skin reactions with Alzheimer's drug galantamine and visual field defects with topiramate to the potentially deadly effects of the antibiotic cotrimoxazole, either alone or when coadministrered with an ACE inhibitor or ARB.

Sample page available for free download.

Breast cancer screening and mammography: inform women

Information must be shared with women to help them decide whether or not to take part in breast cancer screening.

New drug pricing: does it make any sense?

Marc-André Gagnon of Carleton University asks "Why are drugs so expensive?". His analysis exposes the dangers that a business model gone adrift poses to healthcare systems and, ultimately, to patients.

Urinary incontinence: can be drug related

Some drugs cause urinary incontinence, which can have a significant impact on quality of life. Patients should be informed before these drugs are prescribed.

Hydroxyzine: other options are preferable

Hydroxyzine, an antihistamine, is not a first-choice drug. Other drugs have a more favourable harm-benefit balance in some of its approved indications (urticaria, anxiety, insomnia).

Smoking cessation during pregnancy

FEATURED REVIEW Smoking during pregnancy is harmful to the health of the unborn child. When a pregnant woman needs help to stop heavy smoking, nicotine replacement therapy is a reasonable choice. There is no evidence that electronic cigarettes are less harmful for the unborn child than traditional cigarettes.
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International: Dabigatran (Pradaxa°) in deep vein thrombosis and pulmonary embolism

FREE DOWNLOAD In the New Products section of the June issue: compared with adjusted-dose warfarin, dabigatran provides no tangible advantages for patients with pulmonary embolism or deep vein thrombosis. Warfarin remains the standard drug.

Full text available for free download.

Prescrire: financial independence and transparent accounts

Prescrire, financed solely through subscriptions, publishes its accounts each year.

Methylphenidate: adverse cardiovascular effects

Methylphenidate (Ritalin° and other brands) exposes patients to severe adverse effects. It should only be envisaged in cases of severe behavioural disorder, at the minimum effective dose and under supervision.

Epicondylitis (tennis elbow) and corticosteroids: less success than physiotherapy

A local corticosteroid injection gives short-term relief, but increases the risk of recurrence, in contrast to physiotherapy.

International nonproprietary names (INNs): participating in their creation, in order to make them safer

Since 2007, Prescrire has taken part in the World Health Organization’s public consultations on international nonproprietary names, with the aim of making INNs safer.

Human papillomavirus vaccines: 2014 safety review

FEATURED REVIEW The efficacy of HPV vaccines has still not been adequately determined, apart from a preventive effect on precancerous cervical lesions in the years following vaccination. This makes it all the more important to thoroughly assess the adverse effects of HPV vaccination.
Full review (8 pages) available for download by subscribers.

In the May issue of Prescrire International - Simeprevir (Olysio°) in chronic hepatitis C: an option for some patients

FREE DOWNLOAD When triple-drug therapy is considered for chronic hepatitis C due to HCV genotype 1 but sofosbuvir cannot be used, simeprevir seems preferable to other viral protease inhibitors when the virus does not harbour the Q80K substitution.

Full text available for free download.

Prescrire's annual review of drug packaging: Authorities should direct more efforts towards medication safety

In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety.

Hypoglycaemic agents and type 2 diabetes: metformin should be the first-line drug treatment

Metformin is the only drug that appears to prevent some complications of diabetes and reduce the mortality of type 2 diabetes patients.

Being pragmatic

To determine what it will offer in a given clinical situation, three aspects of a drug must be examined: its efficacy, its adverse effects and how easy it is to use in the reality of everyday health care.

Links between experts and drug companies: because they can!

Revelations by French investigative website Mediapart about connivance between senior drug regulators in France and pharmaceutical companies call for a strong response from the government and the medical/pharmaceutical world. One first step would be to ensure that France's version of the "Sunshine Act" actually enables the public to know about the most serious links that exist between health professionals and the drug and device industry, as well as the smallest links.

Glucose-lowering drugs in type 2 diabetes

FEATURED REVIEW Despite the high incidence of type 2 diabetes, the benefit of available glucose-lowering drugs remains very poorly documented. There are no published trials demonstrating that drugs other than metformin reduce either overall mortality or diabetes-related mortality.
Full review (4 pages) available for download by subscribers.

In the April issue of Prescrire International: Green tea leaf extract (Veregen°) - an aggressive topical treatment for anogenital warts

FREE DOWNLOAD In this sample page from the New Products section: while drugs obtained from plants have the reputation of being innocuous, they sometimes provoke serious adverse effects.

Full text available for free download.

Prescrire's yearly review of new drugs and indications in 2014

In its annual recap of drugs reviewed over the past year, independent French medical journal Prescrire points to some advances, but many drugs are poorly evaluated, too expensive or more dangerous than useful.

Osteoarthritis: avoid diacerein

Despite an unfavourable harm-benefit balance and demands by the medicines agencies of several EU Member States for diacerein to be withdrawn, the drug is still on the market.

Epilepsy drug Kaneuron°: hazardous packaging

Because of medication errors, the dosing syringe of the drinkable phenobarbital solution has been replaced. But the packaging is still hazardous: two dosing devices are presented side by side and the bottle has no child-proof cap.

A conference on "The Real Risks of Prescription Drugs" will be held in Washington, D.C. on 11-12 June 2015

Organised by the non-profit group PharmedOut, the conference will include discussions on "Deprescribing", "Misuse of antipsychotic drugs" and a variety of related topics.

"Pay for talk": innovative new programme in France aims to invest in better communication between healthcare professionals and patients

NEWS FLASHDateline Paris, 1 April 2015. France's healthcare system is about to put its money where its mouth is. Independent medical journal La revue Prescrire has revealed that French health authorities are launching a ground-breaking new pilot project called "Pay-for-talk" (P4T). The new "VerbaMed°" application will track how much time healthcare professionals spend actually talking to patients, and the national insurance system will compensate them accordingly.
> For full details, click here

• Decline in vigilance: talk is cheap!

You can say that again! Our desire to communicate more, better and faster can end up bankrupting our sense of what is truly important. We all need an annual April "booster shot", to take a good, hard look at our perception of information.

"Biosimilars": towards fewer obstacles to their use

FEATURED REVIEW The revised guideline on "biosimilars" proposed by the European Medicines Agency in 2013 dispenses with the excessive requirements of the prior version. These copies of biotechnology-derived drugs are a means of driving down the cost of treatment, which in turn helps ensure the sustainability of universal health care.
Full review (4 pages) available for download by subscribers.

In the March issue of Prescrire International: Drugs to avoid in 2015

FREE DOWNLOAD This is Prescrire’s third consecutive annual review of "drugs to avoid". The listed drugs are clearly more dangerous than beneficial and should therefore not be used in any circumstance. The aim is to help healthcare professionals to choose safe, effective treatments and thereby avoid harming their patients.
Full text available for free download.

Multiple sclerosis: neither natalizumab nor alemtuzumab

With the benefit of hindsight, natalizumab (Tysabri°) has proved even more toxic than expected in multiple sclerosis patients. Evaluation of alemtuzumab (Lemtrada°) is too biased for its potential usefulness to be judged, however it exposes patients to severe adverse effects.

Teriflunomide (Aubagio°) is or will soon be on the market in several countries

Teriflunomide (Aubagio°) in the treatment of relapsing-remitting multiple sclerosis is reviewed in the March 2015 issue of Prescrire International The article includes a round-up of reviews from independent editorial teams in various countries.

Prescrire's Drug Awards for 2014: a good vintage

Independent French medical journal Prescrire held its annual awards in Paris on 29 January. This year a "Pilule d'Or" ("Golden Pill") was handed out for the first time in six years, with three drugs added to the "Honours List" and one deemed "Noteworthy".

Prescrire's Drug Packaging Awards for 2014: one winner, but still too many dangerous flaws

The annual packaging awards by independent French medical journal Prescrire demonstrate that quality drug packaging is within reach for drug companies. But too much drug packaging is dangerous and too many leaflets are incomplete.

Prescrire's annual Information Awards: several firms are commended, but too many have underperformed

Pharmaceutical companies' transparency, essential to their credibility, is a critical component in the choice of a drug. The annual Awards from non-profit French medical journal Prescrire reveal which companies practice transparency and which fall short.

Drugs to avoid in the name of better patient care: 2015 update

Too many drugs with an unfavourable harm-benefit balance are on the market. Independent French medical journal Prescrire has updated its list of drugs that ought to be avoided and be replaced by better options.

New drug pricing: does it make sense? A discussion-debate at the annual Prescrire Awards ceremony

Skyrocketing prices for new drugs call for a strong response from citizens, healthcare professionals and health authorities. On 29 January 2015, at its annual "Pilule d'Or" ("Golden Pill") drug awards ceremony, the independent French medical journal Prescrire organised a discussion-debate on new drug pricing.

Imatinib (Glivec°) and acute lymphoblastic leukaemia in children: prolonged survival in Philadelphia chromosome-positive cases

FEATURED REVIEW In children with acute lymphoblastic leukaemia harbouring the Philadelphia chromosome, historical comparisons suggest that adding imatinib to chemotherapy significantly increases the 5-year overall survival rate. Imatinib must continue to be evaluated in this setting but clearly represents a therapeutic advance.
Full review (2 pages) available for download by subscribers.

In the February issue of Prescrire International: Sciatica and epidural corticosteroid injections

FREE DOWNLOADWhat is the analgesic efficacy of epidural corticosteroid injections in patients with sciatic pain? And what are their adverse effects? This sample page from the "Reviews" section explores the harm-benefit balance of this treatment option.

Full text available for free download.

Cholic acid (Orphacol°): major improvement in some bile acid deficiencies

Cholic acid treatment prevents premature death in patients suffering from some hereditary deficiencies and leads to the disappearance of most symptoms.

Serving patients' best interests

Agreeing treatment goals with patients and sharing information without prejudicing their choices is fundamental for enabling patients who so wish to be involved in treatment decisions.

Type 2 diabetes: canagliflozin (Invokana°) should be ruled out

Canagliflozin has an unfavourable harm-benefit balance, as does dapagliflozin. It is best to avoid using these drugs.

Dental caries: can be drug related

Some drugs expose patients to dental caries due to their composition or their action.

Inhibiting onset of lactation: women should opt not to take bromocriptine

Women well informed of the adverse effects generally prefer not to take bromocriptine and are satisfied with their decision.

Semen abnormalities with SSRI antidepressants

FEATURED REVIEW Several studies have found altered semen parameters after exposure to SSRI antidepressants. Although the role of SSRIs is uncertain, it is justified to take into account the observed effects on sperm quality and to inform exposed patients.
Full review (2 pages) available for download by subscribers.

In the January issue of Prescrire International: Strontium still authorised despite an unfavourable opinion of the European pharmacovigilance committee

FREE DOWNLOAD Strontium ranelate (Protelos° - Servier), a drug authorised in the European Union for severe osteoporosis, has at best only modest efficacy in secondary prevention of vertebral fractures. In stark contrast, it carries a risk of disproportionate adverse effects.

Full text available for free download.

Hepatitis C: sofosbuvir, some benefit but minimal evaluation

Sofosbuvir (Sovaldi°) offers an improvement in the treatment of hepatitis C. But its clinical evaluation has been minimal.

Psychiatry: DSM-5 fraught with conflicts of interest

The drawing-up of the American Diagnostic and Statistical Manual of Mental Disorders (DSM) is marred by conflicts of interest.

Ensuring the quality of articles published in Prescrire: the important role of reviewers

All draft articles intended for publication in Prescrire are first reviewed by a diverse panel of professionals. Their comments and suggestions, and the additional references they sometimes provide, help to guarantee the quality of the published articles.

Acute simple cystitis in women: fosfomycin trometamol is the first-choice antibiotic

Single-dose oral fosfomycin trometamol is the first-choice antibiotic for acute simple cystitis.

European pharmacovigilance: increasingly outsourced to drug companies

FEATURED REVIEW New EU regulations on pharmacovigilance were adopted in 2010 and at the end of 2012, following the Mediator° disaster in France. Do these new regulations better protect patients? What are the practical consequences for the various actors in the healthcare system?
Full review (6 pages) available for download by subscribers.

In the December issue of Prescrire International: Trastuzumab emtansine (Kadcyla°). An inadequately assessed combination of two cytotoxic drugs

FREE DOWNLOAD In the "New Products" section of this month's issue, an abstract summarising Prescire's analysis of this combination, which has received EU marketing authorisation in certain types of breast cancer.

Abstract available for free download.

Emergency contraception: an intrauterine device is preferable in cases of overweight and obesity

For overweight or obese women requiring emergency contraception, the fitting of an intrauterine device (IUD) is the first choice.

Hearing loss: sometimes drug related

Some drugs are toxic for the ear. Knowing about them and taking risk factors into account can help prevent the occurrence of sometimes irreversible deafness.

Antibiotic treatment of uncomplicated pyelonephritis in non-pregnant women

The choice of antibiotic treatment for acute uncomplicated pyelonephritis in women should take resistance to antibiotics into account.

Type 2 diabetes and metformin. First choice for monotherapy: weak evidence of efficacy but well-known and acceptable adverse effects

FEATURED REVIEW The efficacy of metformin in type 2 diabetes is still thinly documented in 2014. However, an abundance of data is now available on its adverse effects. The evidence is relatively weak, but long experience with the use of metformin has shown that its adverse effect profile is acceptable.
Full review (4 pages) available for download by subscribers.

In the November issue of Prescrire International: Artesunate - the standard intravenous treatment for severe attacks of malaria

FREE DOWNLOAD Plasmodium falciparum malaria can be life-threatening, particularly in young children, migrants, travellers and pregnant women. This sample page from the "New Products" section of the November issue sums up the factors that make intravenous artesunate the treatment of choice for severe attacks of Plasmodium falciparium malaria.

Full text available for free download.

Telithromycin: too many adverse effects

Telithromycin is an antibiotic that should be avoided due to its disproportionately severe adverse effects.

Harm-benefit balance: a fundamental concept that needs to be grasped

The choice of a medical, diagnostic, therapeutic or preventive intervention is determined by its harm-benefit balance. This concept needs to be fully grasped in order to obtain the maximum benefit that medicine and pharmaceuticals can provide.

Gabapentin and pregabalin: major adverse effects

To reduce the consequences of some severe adverse effects associated with gabapentin or pregabalin, it is advisable not to expose patients to them other than in situations where these drugs have proved to be highly effective.

The 2014 "Prescrire Prize" is awarded in Paris to 5 noteworthy books about health and healthcare

The recipients of the 2014 "Prescrire Prize" book awards were announced on 2 October 2014. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Rivaroxaban 2.5 mg (Xarelto°): no justification for using this anticoagulant after an acute coronary syndrome

FEATURED REVIEW It has not been demonstrated that adding rivaroxaban to aspirin alone or to aspirin plus clopidogrel benefits patients who have had an acute coronary syndrome. The risk of serious and fatal bleeds is probably underestimated. Caution dictates that rivaroxaban should not be added to established antithrombotic therapy in this setting.
Full review (4 pages) available for download by subscribers.

In the October issue of Prescrire International:
adverse effects of boceprevir, colchicine and fluourouracil

FREE DOWNLOAD In this sample page from the Adverse Effects section, haematological disorders with boceprevir, deaths linked to colchicine, and dosing errors with flourouracil.

Full text available for free download.

Metastastic prostate cancer: enzalutamide is useful for some patients

In some cases of advanced metastastic prostate cancer, enzalutamide prolongs survival by around 5 months. It is an alternative to abiraterone especially for patients suffering from cardiac or liver disorders.

Drug authorisations: too few patients involved in trials

Evaluation of new drugs prior to marketing authorisation is inadequate to ensure patient safety.

Tuberculosis: difficult to treat in the case of multidrug-resistance

Tuberculosis caused by mycobacteria that are multidrug-resistant is difficult to treat. The choice of antibiotics is limited and not properly evaluated.

Mr Juncker, medicines are not just a commodity...

Prescrire and the British Medical Journal send a letter to Jean-Claude Juncker, President of the European Commission

Crushing tablets or opening capsules: many uncertainties, some established dangers

FEATURED REVIEW For patients who have difficulty swallowing, a common solution is to crush tablets or open capsules. Before crushing a tablet or opening a capsule, it is better to consider and research the impact it will have on the drug's effects. It is sometimes preferable to use a different dosage form, or a different active ingredient.
Full review (6 pages) available for download by subscribers.

In the September issue of Prescrire International:
Raltegravir in HIV-infected children at least 2 years of age

FREE DOWNLOAD This sample page from the "New Products" section takes a look at raltegravir, now authorised in the EU for HIV-infected children aged at least 2 years. This integrase inhibitor may be a useful addition to optimised antiretroviral treatment for children in treatment failure.

Full text available for free download.

Sofosbuvir (Sovaldi°): dangerous pricing

Clinical evaluation data that are less substantial than had previously been announced, and a wildly excessive turn in the setting of drug prices.

Essential hypertension: in 2014, a thiazide diuretic is the first choice

In 2014, the first-choice treatment for arterial hypertension in non-diabetic patients with no cardiovascular or kidney involvement, is still a thiazide diuretic.

Meningitis B vaccine: useful in the event of an epidemic but adverse effects need to be more clearly identified

The first vaccine against meningitis B has been authorised within the EU. This vaccine may be useful in the event of a meningitis epidemic, but further evaluation is required.

Smoking cessation: varenicline has too many adverse effects to be used or... reused

Varenicline is authorised as a smoking cessation treatment despite its unfavourable harm-benefit balance. Regrettably, this authorisation has now been extended, encouraging varenicline to be reused after the failure of an initial course.

French non-profit journal Prescrire devotes its special summer edition to the theme "Preparing for the future, in the name of better healthcare"

The biennial "Prescrire Encounters" organised by non-profit French medical journal Prescrire were held on 23 and 24 May 2014 at the Bichat medical school in Paris. "Preparing for the future, in the name of better healthcare", the theme of this year’s Encounters, is also the theme of Prescrire’s summer special issue, dated August 2014.

Healthcare professionals and patients: sharing decision-making

Shared decision-making requires healthcare professionals to inquire about their patients' goals and preferences, after having provided them with the information they need.

Patients as agents of improved healthcare quality

From yesterday's "patently incompetent" user of the healthcare system to the knowledgeable patient who is an agent for better health, patients are taking the initiative to participate actively in healthcare.

In the name of better healthcare: different professions training together, in all independence

By participating in education programmes together, healthcare professionals from different fields of practice get to know one another and learn to work together.

Head lice: Dimeticone is the pediculicide of choice

FEATURED REVIEW Pyrethroids are no longer the first-choice treatment for head lice: they are losing effectiveness and may be toxic in the long term. Dimeticone is a better choice, because it has few known adverse effects and proven efficacy.
Full review (4 pages) available for download by subscribers.

In the July issue of Prescrire International: Canakinumab for gout attacks

FREE DOWNLOAD Given its uncertain efficacy on gout-related pain, canakinumab is too risky to use for treatment of gout attacks. Its price is also exorbitant. It is better to stick with existing symptomatic treatments, which should be initiated as early as possible.

Full text available for free download.

"Partnerships" with pharmaceutical companies: treat with scepticism

The various stakeholders in the health sector do not all have the same goals and interests. It is better for each one to advocate a clear position rather than to enter into risky partnerships.

Nail damage: sometimes due to medication

Various drugs cause nail damage, mainly cosmetic but sometimes functional. The damage is generally reversible.

Intravenous iron: pretence on the part of the European authorities

The European Medicines Agency (EMA) has allowed iron dextran, the most dangerous alternative, to remain on the market. The French authorities have had to resort to stratagems to protect patients.

EMA's new policy on access to clinical data: About to privatise pharmaceutical knowledge? The proof will be in the pudding

EMA's controversial policy on access to clinical data is to be adopted by mid-July 2014 while restrictive measures and legal loopholes are left unaddressed. AIM, ISDB, MiEF and the Nordic Cochrane Centre call on the EMA to not succomb to pressures from pharmaceutical companies and the European Commission.

Antibiotic therapy for acute appendicitis in adults

FEATURED REVIEW How effective are antibiotics in adults with uncomplicated acute appendicitis, and what is the risk of complications? To answer these questions, we conducted a review of the literature using the standard Prescrire methodology.
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International -
Towards better patient care: drugs to avoid in 2014

FREE DOWNLOAD In order to help healthcare professionals and patients choose high-quality treatments and avoid harms, we have updated our list of drugs to avoid in early 2014.

Full text available for free download.

Prescrire: financial independence and transparency

Prescrire, financed solely through subscriptions, publishes its accounts each year.

Violent behaviour towards others: sometimes caused by medication

Certain drugs expose patients to violent behaviour, sometimes with tragic consequences.

Alzheimer's: too many patients exposed to drug interactions

A study has shown that many Alzheimer’s patients being treated with an acetylcholinesterase inhibitor are exposed to dangerous interactions with other drugs.

Multiple sclerosis: a cannabis-based drug for some patients

When traditional treatments are deemed unsatisfactory, a combination of cannabis extracts offers an improvement in around 10% of patients with spastic movement disorders.

Insulin degludec: no better than other insulins, and an ill-defined cardiovascular risk

It is better to rule out insulin degludec as a diabetes treatment since it exposes patients to too many uncertainties concerning its adverse effects. Isophane insulin or even insulin glargine, both tried-and-tested, are preferable.

Backpedalling on EMA’s "proactive publication of clinical-data" draft policy: Was it all just a window-dressing exercise? Who or what is the EMA afraid of?

In a Joint Press Release, AIM, ISDB, MiEF and the Nordic Cochrane Centre call on the European Medicines Agency to ensure that its long-awaited policy on proactive publication of clinical data actually improves public access to scientific evidence about the effects of medicines on human health.

Tapentadol: no therapeutic advance for acute or chronic pain

FEATURED REVIEW Tapentadol is an opioid similar to tramadol. For patients with acute or chronic pain, its analgesic efficacy is unknown, due to the lack of high-quality evaluation, but it provokes the adverse effects common to all opioids. It is better to continue relying on better-established opioids.
Full review (4 pages) available for download by subscribers.

In the May issue of Prescrire International: infection-causing antiseptics, rhabdomyolysis with mirtazapine, and a French study of fatal ADRs

FREE DOWNLOAD This sample page from the Adverse Effects section for May gives a taste of the broad variety of crucial information published in every issue of Prescrire International.

Full text available for free download.

Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant

It is unjustifiable to expose patients to the dangers of lorcaserin, which has no tangible effect on the complications of obesity or even on weight. The European Medicines Agency was right to refuse it a marketing authorisation.

Prescrire's yearly review of drug packaging: small changes would reap big benefits

In its yearly review of drugs packaging, the independent French journal Prescrire noted several improvements in 2013, but too many cases of poor-quality or even dangerous packaging.

Diabetes: too many severe adverse effects with gliptins

Gliptins have no proven efficacy in preventing diabetes complications and can cause severe, even fatal, adverse effects, including pancreatic and skin disorders. It is better to avoid these drugs.

Drug-induced corneal damage

FEATURED REVIEW A wide variety of drugs can damage the cornea, with effects ranging from simple asymptomatic deposits to irreversible, sight-threatening damage.
Full review (4 pages) available for download by subscribers.

In the April issue of Prescrire International: a warning on the dangers of insulin at 200 units per ml

FREE DOWNLOAD This sample article from the "Outlook" section explores the ramifications of the recent European decision to authorise insulin at twice the usual strength.

Full text available for free download.

Drug developments in 2013: little progress, but French authorities take a few positive steps to protect patients

2013 saw minimal therapeutic advances, with 15 new drugs or new therapeutic indications deemed dangerous.

Acute pancreatitis: sometimes caused by medication

Many drugs expose patients to sometimes severe damage to the pancreas.

Ties between pharmaceutical companies and regulators: too close for comfort

Pharmaceutical companies have imposed their commercial interests and values, to the detriment of pharmaceutical policies and medical practices.

Mild arterial hypertension: antihypertensive drugs have no proven benefits

Non-drug options are preferable for treating mild arterial hypertension.

Hormone treatment promises to shorten time of pregnancy, yielding cost savings, productivity gains

NEWS FLASHDateline Paris, 1 April 2014. Many drugs have a proven benefit in shortening the natural cycle of illnesses. This phenomenon has now been applied to physiology. A multieccentric growth hormone study versus nocebo in 22 512 pregnant women has shown a reduction of more than 2 months in the length of pregnancy, with no adverse effects reported. The discovery is being hailed as a way to further decrease medical consultation times and hospital stays. The savings to France’s national health insurance system should be substantial. Labour authorities also expect a surge in productivity.
> For full details, click here

• Decline in vigilance: ever a fertile ground for misconceptions!

Not so fast! Our desire for ever greater speed can give birth to some horrendously premature conclusions. We all need an annual April "booster shot", to take a good, hard look at our perception of information.

EU Regulation on clinical trials: close to the finish line

If adopted in early April 2014, the new Regulation on clinical trials should bring greater transparency concerning clinical trial data and results. However, the proposed Trade Secrets directive (published in November 2013) may curb the advances gained in the Clinical Trials regulation.

Vitamin D and rickets: supplementation for some children

FEATURED REVIEW To identify the safest and most effective strategies for preventing rickets due to vitamin D deficiency in France and other Western European countries, we reviewed the available literature using the standard Prescrire methodology.
Full review (6 pages) available for download by subscribers.

In the March issue of Prescrire International: Tenofovir and chronic hepatitis B

FREE DOWNLOAD In the New Products section of the March issue, Prescrire International examines the new indication for the antiviral drug tenofovir (Viread°) in adolescents.

Full text available for free download.

Lithium for bipolar disorder: prevent adverse effects

Lithium is the reference drug for stabilising the mood of patients suffering from bipolar disorder. But it needs to be carefully dosed since there is a very narrow margin between the therapeutic dose and the appearance of sometimes severe adverse effects. With careful adjustment of the dosage the risk of adverse effects remains low.

Sclerotherapy: rare but sometimes severe adverse effects

Injecting sclerosing agents into veins exposes patients to rare but severe adverse effects, generally disproportionate to the desired outcome of treatment.

The anti-inflammatory drug nimesulide has been withdrawn from sale in France, at long last

Patients could have been protected sooner from this drug, which is no more effective than others but can cause serious liver damage.

Is the EMA's window of opportunity as widely open as described?

In a published response to the article in the BMJ "Clinical trial data: get them while you can" (BMJ 2014; 348 g63), Prescrire observes that the European Medicines Agency is not fully meeting its transparency obligations established in EU legislation.

Nausea and vomiting: stop the use of domperidone once and for all

Domperidone (Motilium° or other brands) has modest efficacy against nausea and vomiting. It increases the risk of heart rhythm disorders and sudden death. Based on data on reimbursements paid by the French health insurance system and the incidence of sudden death in France, Prescrire has shown it to be a likely hypothesis that as many as 25 to 120 sudden deaths were linked to domperidone in 2012 in France. It is high time the European health authorities withdrew this drug from the market.

• Domperidone should not be used: 9 articles from Prescrire's ongoing analysis

Prescrire has followed and regularly updated its analysis of domperidone (Motilium° or other brands). The injectable form was withdrawn from the market in 1986 following serious cardiac rhythm disorders, some fatal. Since then, the profile of cardiac adverse effects of the oral forms of domperidone has become clearer: this drug should not be used.

Prescrire's 2013 Drug Awards announced in Paris: just one drug, representing a minor advance, is deemed "Noteworthy"

The independent French medical journal Prescrire held its annual awards in Paris on 30 January. There was no "Pilule d'Or" ("Golden Pill") awarded, and no new additions to Prescrire's "Honours List". Just one drug was deemed to have made a positive, if modest, contribution to patient care.

Prescrire announces its Drug Packaging Awards for 2013: three winners, but many dangerous flaws as well

The independent French medical journal Prescrire announced its annual awards in Paris on 30 January. Three winners for the Packaging Award demonstrate that quality drug packaging is indeed within reach for pharmaceutical companies. But a flurry of "Yellow Cards" and "Red Cards" point to a multitude of dangers from poor packaging and incomplete leaflets.

Independent French medical journal Prescrire announces its Information Awards for 2013: a handful of companies are honoured, but too many lag behind

Pharmaceutical companies' transparency, essential to their credibility, is a critical component in the choice of a drug, ranking just behind efficacy, adverse effects, ease of use and price. The annual Information Awards from the editors of the non-profit French medical journal Prescrire reveal which companies practice transparency and which ones fall short.

"Towards better care: drugs to avoid": the February 2014 update from independent French medical journal Prescrire

Too many drugs with a negative harm-benefit balance are on the market. The independent French medical journal Prescrire has updated its round-up of drugs that ought to be avoided when caring for patients and should be replaced with better options.

Victims of adverse drug reactions;
coming out of denial as a society, in the name of better care

In 2014, in Europe, victims of serious adverse drug reactions are still having huge difficulties in being recognised as such. It is time to point out the inacceptable nature of this situation, and to take action.
A conference-debate on this theme was held at Prescrire's annual "Pilule d'Or" ("Golden Pill") awards ceremony, which took place in Paris on 30 January 2014.

Apixaban (Eliquis°) and atrial fibrillation: no clear advantage

FEATURED REVIEW For the prevention of thromboembolism in patients with atrial fibrillation, there is no evidence that apixaban (Eliquis°) is more effective than well-managed warfarin therapy in patients with a high risk of thrombosis. And there is no antidote in case of overdose.
Full review (4 pages) available for download by subscribers.

In the February issue of Prescrire International: French data on the adverse effects of etoricoxib, and cardiac disorders with pregabalin

FREE DOWNLOAD This sample page from the Adverse Effects section reflects key data gained from reports generated by France's regional pharmacovigilance centres.

Full text available for free download.

Obsessive compulsive disorder: an adverse effect of some drugs

Some central nervous system drugs cause obsessive compulsive disorder. It is best to inform patients and their families, and to be on the lookout for behavioural changes.

Pregnant women: asthma treatment

In 2013, the available data suggest that pregnancy, confirmed or simply a possibility, need not affect the choice of first-line asthma drugs.

Artenimol + piperaquine in malaria

FEATURED REVIEW This fixed-dose combination based on an artemisinin derivative does not represent an advance in the treatment of uncomplicated P. falciparum malaria. When artemisinin-based combination therapy is warranted, it is best to use a better-known combination.
Full review (4 pages) available for download by subscribers.

In the January issue of Prescrire International: bowel cleansers; zolpidem's morning-after effects; the hazards of fentanyl patches

FREE DOWNLOAD This page from the Adverse Effects section of the January issue gives a cross-section of the crucial, independent information in every issue of Prescrire International, covering a wide range of products and situations.

Full text available for free download.

Multiple sclerosis: monitor for the cardiac risks of fingolimod (Gilenya°)

Starting a treatment with fingolimod, or resuming it after a break, exposes the patient to excessive slowing of the heart rate and requires close cardiac monitoring for several hours.

Lung cancer screening: adverse effects, and uncertain benefits

In 2013, to reduce lung cancer deaths, it is better to encourage non-smokers never to smoke, and to help smokers cut down or quit.

An approach to preventing adverse drug effects during pregnancy

Little is known about the risks of adverse effects of drugs during pregnancy. Armed with some basic information, it is possible to develop a practical approach that enables healthcare professionals to prevent these adverse effects.

Insulin use: numerous preventable errors

Insulin-related errors are frequent and often preventable. It is better for health professionals to listen to patients, who are often adept at managing their treatment.

Drug-related cardiac valve disease

FEATURED REVIEW Valve disease is often attributed to degeneration with no known cause. The frequency of drug-related valve disease has long been underestimated. The possible role of a drug should be considered whenever a new case of cardiac valve disease is diagnosed.
Full review (4 pages) available for download by subscribers.

In the December issue of Prescrire International - Ceftaroline fosamil: just another intravenous antibiotic

FREE DOWNLOAD There is no evidence that ceftaroline is more effective than tried and tested antibiotics used in patients with community-acquired pneumonia or serious skin or soft-tissue infections warranting hospitalisation. It is better to stick with established antibiotics.
Full text available for free download.

Domperidone and cardiac disorders: this drug should be withdrawn now

Domperidone can cause severe cardiac disorders. It is better not to use it.

Pharmaceutical marketing: scientific publications used for commercial purposes

Drug companies use various methods to sell their products, including the planned publication of articles in scientific journals, a little-known strategy for influencing healthcare professionals.

Breast cancer: ductal carcinoma in situ - a choice between monitoring and immediate surgery

In cases of asymptomatic ductal carcinoma in situ revealed through mammography screening, clinical monitoring rather than immediate surgery is one of the options to discuss calmly with the patient.

Devil's claw root: ulcers and gastrointestinal bleeding?

Devil's claw root is used in the symptomatic treatment of minor joint pains, even though its efficacy over and above a placebo has not been established. It appears to expose patients to sometimes severe gastrointestinal adverse effects. It is best avoided.

Placebo-Controlled trials

This letter from Prescrire to the Editor of Health Affairs, in response to "Decline in Placebo-controlled trial results suggests new directions for comparative effectiveness research" (Health Affairs, June 2013), was published in their October 2013 issue. In its letter, Prescrire argues that a drug approval system based on placebo-controlled trials does not encourage real therapeutic progress. Quite the contrary, it opens the door to therapeutic regression.

Axitinib (Inlyta°): No better than sorafenib in kidney cancer

FEATURED REVIEW In patients with metastatic kidney cancer in whom interferon alfa has failed, the only available comparative trial showed that axitinib did not prolong overall survival compared to sorafenib. Axitinib has a burdensome adverse effect profile and carries a risk of numerous drug-drug interactions.
Full review (2 pages) available for download by subscribers.

In the November issue of Prescrire International -
Piribedil: sleep attacks, also in patients without Parkinson's disease

FREE DOWNLOADUnnecessary exposure of patients to the adverse effects of piribedil is not justified. It is better to use drugs with demonstrated efficacy instead.

Full text available for free download.

Too much medicine is harmful

Knowing when not to prescribe, how to prescribe wisely and when to “deprescribe” are a challenge for healthcare professionals in which patients should be involved.

Contraception: second-generation pill rather than the contraceptive patch or vaginal ring

An ethinylestradiol and levonorgestrel combination pill remains the best option. Contraceptive patches and vaginal rings expose women to more thromboses.

Pharmacovigilance: the role of France's regional centres

France's annual "Journées de Pharmacovigilance" conference allows a brief glimpse into reports that healthcare professionals have filed with the country's regional pharmacovigilance centres, and into the contents of the country's pharmacovigilance database. Information that is useful for improving patient care.

Ischaemic stroke: sometimes thrombolysis and very often aspirin

In the acute phase of an ischaemic stroke, some patients benefit from thrombolysis when it is administered within 3 hours. Most patients are treated with aspirin.

Skin conditions: soft paraffin is the reference emollient

Soft paraffin is the reference emollient for skin conditions such as psoriasis and burns, because of its efficacy (softens and moisturises) and its minimal adverse effects.

Euthanasia: a practice that has been decriminalised in Belgium, the Netherlands and Luxembourg

In Belgium and the Netherlands, euthanasia accounts for 1 to 3% of deaths, especially in cancer cases.

"Safer naming, labelling and packaging of medicines": a conference in Paris organised by the International Medication Safety Network

Prescrire hosted the IMSN Satellite conference on Thursday 10 October. Representatives from 20 countries held a public debate on the role of drug regulatory agencies and health authorities in assessing and preventing the risks of medication errors.
> Click here for the press release and to download presentations from the conference

The 2013 "Prescrire Prize" is awarded in Paris to 3 noteworthy books about health and healthcare

The recipients of the 2013 "Prescrire Prize" book awards were announced on 3 October 2013. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Discussion-debate: "Self-medication: how much autonomy for patients? What is the role of healthcare professionals?"

On 3 October 2013 the editors of the independent French journal Prescrire will announce the winners of the annual Prescrire Prize, which recognises works that are of interest to the public at large and/or healthcare professionals. The awards ceremony will be followed by a discussion-debate (in French) on the theme of self-medication.

Vitamin D "insufficiency" in adults: beware of vague concepts with uncertain clinical relevance

FEATURED REVIEW There is no proof that measuring blood levels of vitamin D in the general population or in selected subgroups leads to an improvement in the health of those concerned.
Full review (4 pages) available for download by subscribers.

In the October issue of Prescrire International: adverse effects of strontium, SSRI antidepressants, terbinafine and...goji berries

FREE DOWNLOAD This sample page from the Adverse Effects section of the October issue gives a taste of the crucial, independent information in every issue of Prescrire International, covering a variety of topics from widely marketed drugs to alternative remedies.

Full text available for free download.

Pharmaceutical marketing: the harmful influence of pharmaceutical reps' visits on prescriptions

The harmful influence of pharmaceutical sales reps’ visits on prescriptions has long been established and should not be underestimated. Meanwhile pharmaceutical companies and the French Health Ministry are determined to legitimise these visits under cover of a Code of Conduct.

Osteoarthritis of the knee: avoid intra-articular hyaluronic acid injections

At best, intra-articular hyaluronic acid injections give modest relief to patients suffering knee osteoarthritis pain, at the price of local reactions and sometimes severe adverse effects.

Abdominal pain: beware of trimebutine overdose

Trimebutine can lead to abuse and addiction, and cause severe neurological and cardiac disorders in the event of overdose.

"Safer naming, labelling and packaging of medicines":
a conference in Paris on Thursday 10th October, organised by IMSN

The Paris Satellite conference of the International Medication Safety Network will feature a public debate on the role of drug regulatory agencies and health authorities in assessing and preventing the risks of medication errors.
> Click here for details and to register online.

Baclofen and severe alcohol dependence: an uncertain harm-benefit balance as of early 2013

FEATURED REVIEW More data are needed on the efficacy and adverse effects of baclofen in alcohol dependence, compared with other options. Patients who have received thorough, well-balanced information, and decide to try baclofen as a last resort should be included in comparative clinical studies.
Full review (4 pages) available for download by subscribers.

In the September issue of Prescrire International:
Ferumoxytol (Rienso°) - an intravenous iron, riskier than iron sucrose

FREE DOWNLOAD Pharmacovigilance data and the results of a clinical trial show that serious adverse events are more frequent with ferumoxytol (Rienso°) than with iron sucrose.

Full text available for free download.

Intranasal influenza vaccine for children (Fluenz°): it is better to keep to the injectable vaccine

In children where vaccination against influenza is advisable, the live attenuated influenza intranasal vaccine has not been evaluated in terms of influenza complications. It is better to keep to the injectable vaccine.

Peripheral neuropathy: sometimes medication-related

Numerous medicinal products (especially anticancer and anti-infective drugs) expose patients to damage of the peripheral nerves, resulting in highly debilitating disorders.

Bisphenol A: to be avoided

It is advisable to avoid canned food and plastic packaging for storing and re-heating food and beverages, especially for pregnant women and infants.

Self-screening for prostate cancer: ban in France is justified

Screening for prostate cancer by measuring PSA levels presents an unfavourable harm-benefit balance.

Omega-3: ineffective in preventing cardiovascular events

Omega-3 supplements have no proven efficacy in reducing the risk of a new cardiovascular event.

Providing care to pregnant women: do no harm

French medical journal Prescrire devotes its annual special issue to the prudent use of medicines by pregnant women.

Pregnancy: drugs to avoid

A special issue of French medical journal Prescrire examines the risks of medications during pregnancy. Some drugs are known to cause birth defects in the fetus (teratogenic), and are not compatible with pregnancy.

Choosing a treatment with a pregnant woman

In a special issue of French medical journal Prescrire: an approach aimed at avoiding adverse drug effects during pregnancy.

Medication during pregnancy: 10 principles to avoid adverse effects in the unborn child

In the special issue of French medical journal Prescrire: for a woman who is pregnant, or who might be or become pregnant, taking medications can expose the unborn child to harmful effects, often poorly known, and sometimes extremely serious and irreversible. A few principles can be useful in avoiding them.

Do not use drugs to prevent onset of lactation

FEATURED REVIEW We reviewed the available evidence on methods used to prevent onset of lactation. Breast discomfort, however intense, does not justify exposing women to the serious adverse effects linked to postpartum administration of dopamine agonists or oestrogens.
Full review (3 pages) available for download by subscribers.

In the July issue of Prescrire International: Quetiapine and cardiac muscle disorders

FREE DOWNLOAD Reports of myocarditis and cardiomyopathy in patients taking the neuroleptic quetiapine are a cause for concern. Quetiapine is chemically similar to clozapine and olanzapine, both of which are known to sometimes provoke these adverse effects.

Full text available for free download.

HIV: condoms remain the most effective means of prevention

In situations where there is a high risk of HIV transmission, the combination of emtricitabine + tenofovir reduces the risk of the virus being sexually transmitted, but only by half. The condom is a more effective means of prevention.

Meals, a powerful influence on healthcare professionals too

Gifts from pharmaceutical companies to healthcare professionals, particularly dinner invitations, influence them a great deal, even subconsciously. It’s important to know when to say no.

Traumatic bleeding: tranexamic acid reduces mortality

In victims of severe traumatic bleeding, the administration of tranexamic acid, preferably in the hour following the trauma, and in any case within 3 hours, has a favourable harm-benefit balance.

The debate over EU Clinical Trials Regulation: towards a model that meets real public health needs

In a text published in The Lancet (Vol 381, p1719-1720), Prescrire observes that the debate on proposed European clinical trials regulation offers a major opportunity to redirect clinical research and development towards a model that meets real public health needs. Improved access to clinical trial data would allow independent analysis and early detection of safety problems.

Bleeding with dabigatran, rivaroxaban, apixaban: no antidote, and little clinical experience

FEATURED REVIEW Dabigatran, rivaroxaban and apixaban are oral anticoagulants used to prevent or treat thrombosis. Difficulties in the management of bleeding weigh heavily in the balance of potential harm versus potential benefit of these drugs.
Full review (5 pages) available for download by subscribers.

In the June issue of Prescrire International - Strontium ranelate (Protelos°) for osteoporosis in men: more dangerous than beneficial

FREE DOWNLOAD Strontium ranelate is used to treat postmenopausal osteoporosis in women. Serious and even life-threatening adverse effects have been reported since market release in 2005. The drug is now also licensed for the treatment of osteoporosis in men.
Full text available for free download.

Prescrire: financial independence and transparent finances

Prescrire publishes its accounts each year.

Personalised medicine based on pharmacogenetics: a critical approach is called for

As of early 2013, real therapeutic advances in the field of pharmacogenetics are still few and generally modest.

Colorectal cancer: "antioxidants" have no preventive effect

"Antioxidants" have no place in the prevention of colorectal cancers. Furthermore, they may be harmful.

Guard against drug companies' influence on healthcare professionals, starting with medical students

Teachers and students in the healthcare field have a key role to play in keeping pharmaceutical companies at arm's length, so as not to jeopardise the quality of their training and their practice.

Washington conference produces a "Call to action on selling sickness"

Prescrire has endorsed the "Call to action on selling sickness", a statement that came out of the conference "Selling Sickness, 2013: People before Profits" held in Washington DC in February 2013. The statement is reproduced here.

Deep venous thrombosis and pulmonary embolism:
prevention of recurrences

FEATURED REVIEW After the initial phase of treatment for deep venous thrombosis or pulmonary embolism, the goal is to prevent recurrences, which can be fatal. In practice, it is best to choose between low-molecular weight heparin (LMWH) and warfarin, on a case-by-case basis.
Full review (5 pages) available for download by subscribers.

In the May issue of Prescrire International: Panitumumab (Vectibix°) as adjunctive therapy for metastatic colorectal cancer

FREE DOWNLOAD This text from the New Products section of the May issue of Prescrire International concludes that panitumumab has no place in either first- or second-line treatment of metastatic colorectal cancer.

Full text available for free download.

Prescrire looks back at drugs packaging in 2012: too many dangerous flaws

The analyses carried out over the past year by Prescrire's editors reveal that in too many cases, drug packaging is dangerous for children. Too many patient leaflets contain incomplete information on adverse effects, resulting in the most vulnerable patients being the least protected.

Oral methotrexate: risk of a fatal overdose

The packaging of oral methotrexate-based drugs should be improved so as to avoid fatal dosage errors.

Idiopathic pulmonary fibrosis: avoid pirfenidone (Esbriet°)

The lack of an effective treatment for idiopathic pulmonary fibrosis, a rare disease, does not justify the use of pirfenidone: this drug's harm-benefit balance is unfavourable.

Health research: fraud is too widespread!

It is high time to put an end to the blind faith placed in researchers’ findings, and to make it possible for their results to be verified.

Mephenesin: abuse and dependence

Mephenesin is a muscle relaxant with psychotropic effects, leading to abuse and dependence. It is better to avoid mephenesin, especially in patients with a history of abuse and dependence.

Lessons learnt and to be learnt: PRAC and CHMP say no to dangerous drug

In a published response to Gary Taube's essay "The science of obesity: what do we really know about what makes us fat?" (BMJ online, 16 April 2013), Prescrire welcomes the European Medicines Agency's refusal to grant marketing authorisation to the fixed-dose combination of topiramate and phentermine.

ADR: a new global phenomenon, thanks to the ICH

EXCLUSIVE Dateline Paris, 1 April 2013. French journal Prescrire reports unbelievable news regarding the creation of the worldwide Agency for Drug Reconciliation (ADR).

• Decline in vigilance: worldwide epidemic!

Something fishy is going on here! In an increasingly interconnected world, we all need an annual April "booster shot", to take a good, hard look at our perception of information.

Bismuth + metronidazole + tetracycline (Pylera°) for peptic ulcer associated with Helicobacter pylori: why risk adding bismuth?

FEATURED REVIEW The standard treatment for peptic ulcer associated with Helicobacter pylori is a combination of omeprazole, amoxicillin and clarithromycin. The 4-drug regimen comprising omeprazole + bismuth subcitrate potassium + metronidazole + tetracycline is at least as active against the infection, but there are too many questions regarding its adverse effects. Better to avoid bismuth pending further evaluation.
Full review (4 pages) available for download by subscribers.

In the April issue of Prescrire International: Prescrire's editors look back at new drugs and new indications in 2012

FREE DOWNLOAD The therapeutic advances identified by the editors of independent French journal Prescrire in 2012 were minimal. And 15 new drugs or indications reviewed during the past year are actually dangerous.

Full text available for free download.

Towards better patient care: drugs to avoid

FREE DOWNLOAD The text published in the April issue of Prescrire International lists the principal drugs that Prescrire considers to be more harmful than beneficial, based on reviews published between 2010 and 2012 in the French edition. These drugs should not be used.

Full text available for free download.

Delayed wound healing: sometimes due to drug treatment

Some drug treatments slow down the healing process, especially if the wound is deep. These are best avoided if possible.

Deep venous thrombosis and pulmonary embolism: initial treatment

Patients suffering from deep venous thrombosis are exposed in the short term to a risk of pulmonary embolism, which is often fatal. A low-molecular-weight heparin (LMWH) injected subcutaneously is the first-line anticoagulant for this condition.

Topiramate + phentermine (Qsiva° and other brands): an excessively dangerous appetite-suppressant combination

FEATURED REVIEW Overweight and obese patients must not be exposed to the topiramate + phentermine combination. No beneficial impact on clinical complications of obesity has been demonstrated. A portion of the weight lost is regained after treatment withdrawal. And numerous serious adverse effects have already been observed.
Full review (4 pages) available for download by subscribers.

In the March issue of Prescrire International:
The dangers of vasoconstrictive decongestants

FREE DOWNLOAD A sample page from the Adverse Effects section of this month's issue of Prescrire International features two articles on this important subject.

Full text available for free download.

Health professionals and patients should be encouraged to report drugs' adverse effects

The reporting of adverse effects by health professionals is an activity of benefit to the community which takes little of their time. The health authorities should encourage them to do so, particularly by giving them feedback.

Anxiolytic drug etifoxine (Stresam°) causes too many severe adverse effects

The anxiolytic drug etifoxine causes adverse effects so severe that it should no longer be used.

Depression: avoid agomelatine (Valdoxan° and other brands)

The harm-benefit balance of the antidepressant agomelatine is markedly unfavourable.

Prescrire's 2012 Packaging Awards: too many dangerous flaws in drug packaging

In too many cases, drug packaging is dangerous for children. Too many patient leaflets contain incomplete information on adverse effects, resulting in the most vulnerable patients being the least protected.

The Prescrire Information Awards for 2012: a few companies to be commended, but too many "Red Cards"

The pharmaceutical company's transparency, as an indicator of its credibility, is one of the criteria in choosing a drug, along with efficacy, adverse effects, usability and price.

The 2012 Prescrire Drug Awards: too little genuine progress for patients

Two new drugs were rated “Noteworthy”, but the Prescrire Awards for 2012 included no “Golden Pill” award and no additions to the “Honours List”.

Dabigatran (Pradaxa°): life-threatening bleeding

FEATURED REVIEW Dabigatran is an oral anticoagulant that inhibits thrombin but not vitamin K. Pharmacovigilance studies have identified several situations in which patients have an increased risk of serious bleeding with dabigatran. Dabigatran should be reserved for patients at high risk of thrombosis in whom antivitamin K therapy poses difficult problems.
Full review (3 pages) available for download by subscribers.

In the February issue of Prescrire International: adverse effects of metformin, methylphenidate and benfluorex

FREE DOWNLOAD On this sample page drawn from the Adverse Effects section of Prescrire International's February issue: preventing adverse effects of metformin; methylphenidate abuse on the rise in Europe; and unsatisfactory delays in publishing the adverse effects of benfluorex.

Full text available for free download.

Psychomotor developmental disorders: a link to antidepressants?

It is best to avoid prescribing SSRI antidepressants (paroxetine and others) as a first-line treatment for pregnant women.

Pharmacovigilance by drug companies: mission impossible

Pharmaceutical companies cover up the adverse effects of their drugs, and fail to live up to their own claims of informing the public and carrying out pharmacovigilance

Drugs in wastewater: treatment plants are not eliminating them completely

Water treatment plants are not fully removing drugs from wastewater. Yet another reason to avoid the overconsumption of drugs and to return unused medications to the pharmacy for incineration.

Locally advanced prostate cancer: effective treatments, but many adverse effects

FEATURED REVIEW Before choosing between therapeutic options, it is crucial to take into account the patient’s priorities in terms of treatment efficacy and adverse effects, and reversibility of adverse effects.
Full review (6 pages) available for download by subscribers.

In the January issue of Prescrire International: adverse effects of corticosteroid injections, azithromycin and saxagliptin

FREE DOWNLOAD This sample page from the "Adverse Effects" section demonstrates just how much information on drugs and their adverse effects comes in every 28-page issue of the monthly journal Prescrire International.

Full text available for free download.

Type 2 diabetes: avoid intensive treatment

Clinical trials confirm that intensive treatment should be avoided in diabetic patients with a high cardiovascular risk. The aim should be to achieve an HbA1c level no lower than 7% to 7.5%.

Clinical research: access to raw data is essential

Too frequently, the pharmaceutical companies alone hold the individual patient data from clinical trials, with the risk that further analyses of the results will be distorted.

Surgery: patient mix-ups and wrong-site errors are preventable

The use of a safety checklist and the patient’s active involvement help avoid errors, in particular in communication and diagnosis prior to surgery.

Grapefruit and drug interactions

FEATURED REVIEW Numerous drugs interact with grapefruit juice. Although only a few reports involving severe clinical consequences have been published, they suggest that grapefruit juice should be avoided during drug therapy, especially when the drug has a narrow therapeutic margin or carries a risk of serious dose-dependent adverse effects. Patients should be informed of this risk.
Full review (5 pages) available for download by subscribers.

In the December issue of Prescrire International: Herpes zoster vaccine (Zostavax°) is poorly effective in those who need it most

FREE DOWNLOAD Vaccination of the elderly against zoster has a modest preventive effect, but apparently not in those at highest risk (age over 80 years, onset of immunosuppression).

Full text available for free download.

Immunoassay-based screening for colorectal cancer: cancers detected, at the cost of colonoscopy-related complications

Compared with the traditional Haemoccult° test, immunochemical tests seem to improve colorectal cancer screening. But they double the number of colonoscopies carried out, increasing the number of colonoscopies with no lesions detected and the number of colonoscopy-related complications.

Medicinal products packaging: too often overlooked

The packaging of medicinal products plays an important part in their correct use. Too often it is neglected by pharmaceutical companies and regulatory bodies, but healthcare professionals need to be aware of the issue and take action.

The origins of mental disorders: information is often biased

Scientific publications and the mainstream media alike exaggerate the role of biology and genetics in mental disorders.

Who benefits from the European Paediatric Regulation?

Prescrire's response to the European Commission’s public consultation on the lessons learnt from the first 5 years of application of the Paediatric Regulation (1).

European medical device regulation: an entire overhaul is urgently needed

In a published response to the article "Medical devices: EU approval system leaves door open for dangerous devices" (BMJ online, 24 October 2012), Prescrire, together with the AIM, ESIP, the ISDB and the MiEF, underlines the failings of the European device regulation as demonstrated by the recent BMJ investigation, and recommends several important changes if patient safety is to be at the heart of the new regulation.

Rivaroxaban (Xarelto°) and atrial fibrillation: continue to use warfarin or, in some cases, dabigatran

FEATURED REVIEW In patients with atrial fibrillation and a high risk of thrombosis, it is better to continue to use warfarin, a tried and tested drug, and to consider dabigatran when warfarin fails to maintain the INR within the therapeutic range.
Full review (5 pages) available for download by subscribers.

In the November issue of Prescrire International -
Orodispersible paracetamol tablets: danger of poisoning in children

FREE DOWNLOAD Overdose of paracetamol (also known as acetaminophen) can cause serious and sometimes fatal liver damage. It is essential to keep medicines out of reach of children and to warn relatives and carers that paracetamol is highly toxic in case of overdose. Safety of packaging remains a key factor.

Full text available for free download.

Tuberculosis: in case of exposure, monitor those who are most at risk

The care of a person who has been in contact with a tuberculosis patient generally requires simple monitoring for 2 years and sometimes prophylactic treatment.

European Medicines Agency: rife with conflicts of interest

An official audit has laid bare the European Medicines Agency’s irresponsible management of conflicts of interest both among its personnel and the external experts it consults.

Treatment objectives: should be shared with patients

The objectives of a treatment can depend on different approaches, which should be shared with patients.

Discussion-debate : "Is too much cancer screening hazardous to your health? The example of breast cancer"

Peter Gøtzsche, a world-renowned expert in the systematic review of clinical trial data, has for many years been studying the question of breast cancer screening. He came to the ceremony for the "Prescrire Prize" book awards in Paris on 4 October 2012 to present his analysis of the limited benefits of such screening, and the real and frequent harms that it causes.

The 2012 "Prescrire Prize" is awarded in Paris to 5 noteworthy books about health and healthcare

The recipients of the 2012 "Prix Prescrire" book awards were announced on 4 October 2012. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Asenapine (Sycrest°): a less effective, yet more dangerous, neuroleptic

FEATURED REVIEW Asenapine is no more effective or convenient to use than other neuroleptics, while it carries a risk of additional, sometimes severe, adverse effects. This drug should not be used.
Full review (4 pages) available for download by subscribers.

In the October issue of Prescrire International: adverse effects of nicorandil, varenicline, venlafaxine and benfluorex

FREE DOWNLOAD This excerpt from the latest issue demonstrates the variety of information on medicines and their adverse effects published every month in Prescrire International.

Full text available for free download.

Localised prostate cancer: treatment according to the risk of progression

Treatment of localised prostate cancer depends on its progression. Patients should be involved in the decision and well informed of the benefits and harms of the different options.

IUD insertion: possible immediately after an abortion

After an abortion in the first trimester of pregnancy, the immediate insertion of an IUD is at least as effective, and no riskier than a deferred insertion.

Methylphenidate: abuse and addiction

Methylphenidate is an amphetamine-type psychotropic drug often too widely used for treating "hyperactive" children. Its misuse therefore comes as no surprise and is a cause for concern.

Adrenaline self-injection: beware of accidental injection

Thorough and repeated training of healthcare professionals, patients and their carers in the use of an autoinjector is the main preventive measure against handling errors.

Pharmaceutical companies: a reliable investment

Pharmaceutical companies have remained relatively unaffected by the financial crisis. The drugs that generate the biggest profits are not always the first-line option for patients.

Homeopathy: still no proven efficacy

A review of clinical trials has not produced convincing evidence of homeopathy's efficacy.

Atopic eczema: avoid topical tacrolimus

France will not reimburse topical tacrolimus in prophylaxis of atopic eczema due to concerns about the risk of cancer.

"Medicinal" plants: severe hepatitis with Pelargonium

Sometimes commercialised as a simple food supplement, medicinal plants are not always harmless. This is regrettable, especially when they offer no proven benefits.

European Medicines Agency and pharmacovigilance: no to a fee-for-service system

In a joint press release, the International Society of Drug Bulletins, the Medicines in Europe Forum and HAI Europe argue that the European Commission’s proposed pharmacovigilance fee structure turns the European Medicines Agency (EMA) into a mere provider of services to the pharmaceutical industry . Other funding strategies need to be considered to safeguard the Agency’s independence.

Black triangle for medicines: Positive move but poor implementation plan

In a joint press release, the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) observe that the draft paper on the quality review of documents submitted for consultation by the European Medicines Agency (EMA) does not reflect the spirit of the new pharmacovigilance legislation, which is to prevent drug-induced harm.

Apixaban. After hip or knee replacement: low-molecular-weight heparin remains the standard treatment

FEATURED REVIEW In 3 trials including a total of nearly 12 000 patients undergoing hip or knee replacement surgery, apixaban was not more effective than enoxaparin on relevant clinical endpoints. The bleeding risk was not lower with apixaban than with enoxaparin. It is better to continue to use a low-molecular-weight heparin such as enoxaparin.
Full review (4 pages) available for download by subscribers.

In the September issue of Prescrire International - Management of serious adverse drug reactions: proposals from a victims' organisation

FREE DOWNLOAD The position statement on drug-related risks from the French victims' organisation Amalyste provides valuable food for thought, both for healthcare professionals and for drug regulatory agencies, and has the potential to improve practice.

Full text available for free download.

Prostate cancer: too many adverse effects from PSA-based screening

There is no evidence to support PSA-based testing to screen for prostate cancer, whereas the adverse effects have been demonstrated.

Amphetamine-based appetite suppressants: phentermine should not be authorised for sale

Phentermine could come back onto the French market, despite the risk of severe adverse effects.

Non-latex condoms: break more frequently

Latex condoms sometimes cause irritation and allergies, and so condoms made from other materials which do not have this drawback are used instead. However, non-latex condoms have been shown to break more frequently than latex ones.

Type-2 diabetes: self-monitoring of blood glucose levels not a key factor in reducing complications

Self-monitoring of blood glucose levels does not play a big part in preventing complications associated with type-2 diabetes, but it does increase anxiety and mood disorders.

Oral isotretinoin: patient information to prevent risks

It is crucial for patients and those around them to be given detailed information about the serious harms associated with oral isotretinoin. In France, a patient leaflet has been produced to add to this information.

The 2012 "Prescrire Encounters": working together in the name of better care

Posters and videos from the 2012 "Prescrire Encounters", which were held in Angers, France on 25-26 May 2012, are available online.

Improving healthcare by sharing patients' real-life experiences

Two UK websites allow patients and those close to them, as well as healthcare professionals, to share the diversity of personal experiences around health and illness.

Healthcare professionals: working together

Healthcare professionals are increasingly working together, with each other as well as with patients, in the name of better care.

Learning together: sharing continuing education with other healthcare professionals and with patients

For healthcare professionals, developing technical and interpersonal skills takes on a new dimension when continuing education is shared with members of different professions, or even with patients.

France's neighbourhood healthcare centres: easier access to quality care

In France the neighbourhood healthcare centres known as "maisons de santé" are gaining ground, often as a way to work collaboratively and to offer new services.

The International Nonproprietary Name (INN): numerous advantages

Using the INN (International Nonproprietary Name), a drug’s real name, ensures that key information gets across.

Subscribe online for easy access to our database of articles in English

Subscribe today and enjoy instant access to the full database of articles in English published in Prescrire International since 1992. Subscribing online is fast and easy.

Saying "no thanks" to the pharmaceutical industry's undue influence

In a published response to Andrew Jack's article "Mea culpa: are multi-billion dollar fines forcing drug companies to clean up their act?" (BMJ online, 18 July 2012), Prescrire points out that the need to root out undue influence does not stop there.

A missed opportunity to strengthen patient safety: not seeing the forest for the trees

In a published response to the article "New EU drug safety committee ends national reporting of drug reactions" (BMJ online, 9 July 2012), Prescrire argues in favour of a cautious approach.

Paracetamol during pregnancy: no particular danger for the child

FEATURED REVIEW Does paracetamol exposure in utero increase the risk of birth defects, particularly cryptorchidism persisting beyond one year of age? To answer this question, we conducted a review of the literature using the standard Prescrire methodology.
Full review (5 pages) available for download by subscribers.

In the July issue of Prescrire International: domperidone should be avoided

FREE DOWNLOAD It is unacceptable to expose patients with simple gastroesophageal reflux or nausea and vomiting to a risk of severe ventricular arrhythmia and sudden death.

Full text available for free download.

Anti-cancer drugs: exorbitant prices

The soaring prices of new anti-cancer drugs are unrelated to development costs or to the clinical benefits these drugs offer.

Alcohol-based hand sanitizers: serious intoxication in children

Alcohol-based hand sanitizers are in widespread use but can provoke serious alcohol intoxication when accidentally swallowed by a child.

Corporate influence over clinical research: considering the alternatives

This text in the July issue of Prescrire International is based on a lecture given at the annual Prescrire Awards ceremony in Paris by Marc-André Gagnon PhD, Assistant Professor in Public Policy at Carleton University (Canada) and Research Fellow in Ethics at Harvard University (USA).

• Videos of the lecture "Corporate influence over clinical research: considering the alternatives"

VIDEO View the presentation (in French) given by Marc-André Gagnon at the annual Prescrire Awards ceremony in Paris on 26 January 2012.

Arterial hypertension: don’t expose patients to the adverse effects of aliskiren

In the absence of proven efficacy based on robust clinical criteria, and given the risk of severe adverse effects, the use of aliskiren to treat arterial hypertension cannot be justified.

Atopic eczema in infants: avoid topical fluticasone

Given their adverse effects, topical corticosteroids should not become trivialised, especially in infants.

Period pains: no self-medication with flurbiprofen

Flurbiprofen is not the first-line nonsteroidal anti-inflammatory drug (NSAID) for treating period pains. The French drug regulatory agency was right to refuse to encourage its use as self-medication.

Ipilimumab in metastatic melanoma: more assessment is needed

FEATURED REVIEW Two trials in metastatic melanoma suggest that ipilimumab is beneficial. But the benefits in previously untreated patients are not particularly noteworthy, and serious adverse effects can undermine the quality of survival. Use of ipilimumab should be limited to clinical trials designed to better assess the harm-benefit balance and to determine the optimal dosage.
Full review (3 pages) available for download by subscribers.

In the June issue of Prescrire International:
Bevacizumab - lessons from the other side of the Atlantic

FREE DOWNLOADThe differences in the regulatory histories of bevacizumab in breast cancer between the United States and Europe clearly illustrate the issues associated with the evaluation of cancer drugs.
Full text available for free download.

Beware of abuse and dependence with gabapentin and pregabalin

Increasing the dose, withdrawal syndrome sometimes resulting in hospitalisation, and abuse: three good reasons for re-evaluating the harm-benefit balance on a case-by-case basis for these substances used to treat some forms of epilepsy, neuropathic pain and generalised anxiety.

Opinion leaders' brand image used to promote pharmaceutical companies

Pharmaceutical companies use key opinion leaders from the world of medicine in their promotional strategies.

Papillomavirus vaccine: no risks to the unborn child

The data available at the beginning of 2012 on women exposed to papillomavirus vaccines during the first three months of pregnancy do not give cause for concern. In the light of the global data available, severe adverse effects in women are rare.

International Society of Drug Bulletins holds its 9th General Assembly: "Fit for the future! Independence & sustainability"

The ISDB's 9th General Assembly in Vancouver affirms the organisation's continued vitality and its commitment to independent information.

Drug-induced colour vision disorders

FEATURED REVIEW Acquired colour vision disorders may be caused by ocular, neurological or metabolic disorders, but they can also be drug-induced. In some cases, these disorders may precede or reveal the onset of severe and sometimes irreversible eye damage. The drugs implicated mainly include: phosphodiesterase type 5 inhibitors such as sildenafil; digoxin; anti-infectives including interferon alfa; ethambutol; metronidazole; and some antimalarials.
Full review (3 pages) available for download by subscribers.

In the May issue of Prescrire International: 2011 drug packaging review.
Too many dangers and too many patients overlooked

FREE DOWNLOAD Every year, Prescrire's analysis of drug packaging confirms the importance of taking packaging into account in assessing a drug's harm-benefit balance.
Full text available for free download.

Warts: spontaneous healing is frequent

Plantar warts have a high healing rate over time. Treatments make little difference.

Tianeptine (Stablon°) as an antidepressant: too high a risk of dependence

Tianeptine (Stablon°), marketed as an antidepressant, should be avoided as it carries a high risk of dependence. The risks have been known for a number of years, but health authorities are still ignoring them.

Adverse effects: means of increasing reporting

Effective local initiatives have been set up in several French regions to improve the gathering of reports of adverse effects.

Prescrire: financial transparency, editorial independence

Prescrire makes its accounts public every year.

No grants. No advertising. No conflicts of interest.

Every year Association Mieux Prescrire (AMP), the French non-profit that publishes Prescrire and Prescrire International, publishes its accounts in full. This allows readers to see exactly where our money goes – and especially where it comes from.

A new drug treatment makes headlines in France:
olanzapine + topiramate (Obéfix°), maintains ideal weight without risk

BREAKING NEWS Dateline Paris, 1 April 2012. French medical journal La revue Prescrire has revealed unbelievable new results that will be welcome reading for medical professionals and patients alike. A new combination drug, soon to be launched under the brand name Obéfix°, promises to change the way we think about maintaining an ideal weight.

• Decline in vigilance: a danger to public health!

We all need an annual April "booster shot", to help us to take a good look at our perception of information.

Boceprevir (Victrelis°). In triple-drug combination: virological advantage in chronic hepatitis C

FEATURED REVIEW In chronic hepatitis C caused by genotype 1 virus, adding boceprevir to the standard combination of peginterferon alfa + ribavirin markedly increases the rate of sustained virological response, with acceptable adverse effects. Thus, the addition of boceprevir to standard therapy is justified, but evaluation must continue to determine long-term clinical outcomes.
Full review (4 pages) available for download by subscribers.

In the April issue of Prescrire International:
a look back at new drugs and new indications in 2011

FREE DOWNLOAD In their annual wrap-up, Prescrire's editors conclude that while France is better focused on patients' interests after the Mediator° scandal, there is stagnation elsewhere.The feature includes a too-long list of drugs with more harms than benefits that are still on the market in France. And sums up the timid progress made in France's new drugs policy initiative.

Full text available for free download.

Pharmacovigilance: databases accessible to the public

Full public access to pharmacovigilance databases is already in place in 4 countries, but is still a long way from being a reality in France.

Smoking and pregnancy: bupropion (Zyban°) should be avoided due to a risk of heart damage to the unborn child

Bupropion (Zyban°), an amphetamine used in smoking cessation, has an unfavourable harm-benefit balance. Increased frequency of cardiac malformations in babies born to mothers who took the drug during pregnancy is one more reason not to use bupropion.

Fingolimod (Gilenya°): EMA's lack of transparency spells danger for patients

The European Medicines Agency (EMA) refused to supply Prescrire with data on cases of death following the first dose of fingolimod (Gilenya°). Read on for a summary of the press release issued by Prescrire on 20 February 2012, and an update detailing EMA’S latest refusal.

Bleeding from ruptured oesophageal varices: propranolol for primary prevention

FEATURED REVIEW Oesophageal varices are a common complication of cirrhosis. Bleeding from ruptured oesophageal varices is fatal in about 20% of cases. Propranolol should be used for both primary and secondary prevention of bleeding from ruptured oesophageal varices, because of its favourable harm-benefit balance, convenience, and low cost. If propranolol has unacceptable adverse effects or is contraindicated, endoscopic ligation is the best alternative.
Full review (5 pages) available for download by subscribers.

In the March issue of Prescrire International:
healthcare products are involved in about half of all serious adverse events related to healthcare in France

FREE DOWNLOAD A French study revealed that healthcare products are involved in about half of all serious adverse events related to healthcare. These adverse events generally involve a drug, sometimes a medical device, and more rarely a labile blood product.

Full text available for free download.

Orlistat (Xenical°, Alli°): severe kidney and liver damage

Orlistat, a drug used for weight loss, can cause severe adverse effects, notably kidney and liver damage.

Osteoporosis : avoid strontium ranelate (Protelos°)

Strontium ranelate should be avoided as a treatment for osteoporosis due to its disproportionate adverse effects.

Research financed independently of drug companies: a timely debate

Regulatory agencies cannot properly evaluate medicines based on industry-generated data alone.

Fingolimod (Gilenya°): European Medicines Agency's lack of transparency spells danger for patients

The European Medicines Agency (EMA) has refused to supply Prescrire with the detailed data in its possession on cases of death which occurred following the first dose of fingolimod (Gilenya°). This lack of transparency spells danger for patients.

The 2011 Prescrire Awards are announced in Paris

This year's annual Drug Awards, announced on 26 January in Paris, included not a single winner: no "Golden Pill", no new entries to the "Honours List", not even a "Noteworthy" new drug. Prescrire's annual awards for Drug Packaging and Information were also announced.

Drug research financed independently of pharmaceutical companies: for better patient care

Financing of drug research by pharmaceutical companies has numerous drawbacks. Independent clinical trials should be developed, in the interest of patients. A conference-debate on this theme was held at Prescrire's annual "Pilule d'Or" ("Golden Pill") awards ceremony, which took place in Paris on 26 January 2012.

Pregnancy and alcohol: occasional, light drinking may be safe

FEATURED REVIEW There is a risk of cognitive and behavioural problems in children whose mothers regularly drank more than 2 standard units of alcohol per day during pregnancy. Fetal alcohol syndrome occurs in about 5% of cases of regular exposure to five or more standard units per day. Women must be informed, but the risks of minimal consumption should not be overstated.
Full review (7 pages) available for download by subscribers.

In the February issue of Prescrire International:
Mobility aid-related accidents in children

FREE DOWNLOAD Mobility aids for children can be a source of accidents. Wheelchairs are the devices most often involved, followed by crutches and walkers. Correct use of these devices should be explained to parents and children, and children using them should be supervised if necessary.
Full text available for free download.

Patients want to know

Less advice, more explanations! Many patients expect healthcare professionals to help them develop their skills so they can take an active part in making decisions affecting their health.

Smoking cessation: no varenicline

Varenicline is used as a smoking cessation drug. It exposes patients to neuropsychological adverse effects, including depression and suicide, and there is a risk of cardiovascular events in the long term. In practice, it is better to avoid prescribing varenicline as a smoking cessation drug and to keep to nicotine when a drug treatment is deemed necessary.

Outpatient care: preventable adverse events too frequent

At least 40% of severe adverse events related to outpatient care that have resulted in hospitalisation appear to be preventable. They are chiefly drug-related.

How a review in Prescrire is produced

Prescrire's reviews are produced through a complex, collective editing process, which has been fine-tuned over the years. The absence of any direct or indirect financial links to the phramaceutical industry is an absolute requirement to be a member of the Prescrire editorial team.

Sedation at end of life: When distress is unbearable despite treatment

FEATURED REVIEW The decision to begin terminal sedation is difficult; it should only be taken when the patient is in extreme distress. What are the principles, practices and ethics of palliative sedation in distressed terminally ill patients? To answer this question, we reviewed the relevant literature using the standard Prescrire methodology.
Full review (5 pages) available for download by subscribers.

In the January issue of Prescrire International:
fentanyl nasal (Pecfent°), still no tangible advantage

FREE DOWNLOAD Fentanyl intranasal proved no better than immediate-release oral morphine in a trial including 84 patients, but caused more frequent adverse effects. There is a risk of overdose due to confusion between the different forms and doses of fentanyl.

Full text available for free download.

Prostate cancer: too many unknowns with cabazitaxel

In patients with metastatic prostate cancer, when treatment fails, the emphasis should be on quality palliative care.

Migraine: sumatriptan remains available only on prescription in France

Oral sumatriptan for the treatment of migraine in adults remains available only on prescription.

Weight gain: drug treatment may be the cause

Drugs can sometimes disrupt one or several weight-regulation factors. Psychotropic drugs are most often implicated.

Prescrire International turns 20

Independent journal la revue Prescrire launched its English edition in March 1992. The goal was to achieve wider impact for Prescrire's views and reviews on drugs and therapeutics, especially outside France.

To promote better medical education, Prescrire publishes a new handbook devoted to pharmacovigilance and clinical pharmacology

The scandal caused in France by the deadly effects of weight-loss drug Mediator° is in part the result of healthcare professionals' insufficient training in clinical pharmacology and pharmacovigilance. In response to the need for better education in this area, independent journal La revue Prescrire has produced a handbook in French, available free of charge online.

Botulinum toxin type A for migraine: first, do no harm

FEATURED REVIEW Given its uncertain efficacy, at best only modest, botulinum toxin type A is simply too risky a treatment for migraine. It is better to focus on fine tuning of standard prophylaxis.
Full review (4 pages) available for download by subscribers.

In the December issue of Prescrire International:
Bleomycin in malignant pleural effusion

FREE DOWNLOAD Some cancer patients develop malignant pleural effusion that persists or recurs despite cytotoxic chemotherapy and drainage. For pleurodesis, it is better to choose talc rather than bleomycin, as it is safer and no less effective.

Full text available for free download.

To prevent repeats of the Mediator° (benfluorex) disaster:
attitudes need to change

Healthcare professionals and patients, as well as drug experts and health authorities, must learn to balance medicines’ harms against their benefits.

Small gifts: proved to have an influence, albeit often unconscious

Knowing that attitudes can be influenced by gifts – even small ones – and exposure to promotional items (posters, pens, etc.) helps to avoid being manipulated.

Pharmaceutical companies and patient groups: the influence of funding

Patients rely on patient groups to make their views heard, to participate in discussions and to defend their interests -- not those of firms.

Prescrire's "Non merci…" Charter = no conflicts of interest

In order to deliver the best possible care, healthcare professionals need to base their work and their decisions on reliable and independent information.

Gingival hyperplasia can be drug-related

Some drugs can cause gingival hyperplasia. Reducing the dose, halting treatment and good oral and dental hygiene are generally sufficient to reduce or stop the lesions.

Psychological consequences of DES exposure in utero

FEATURED REVIEW Between the 1950s and the late 1970s, millions of women worldwide took diethylstilbestrol (DES) during pregnancy. The data suggest that persons exposed to DES in utero have an increased risk of experiencing psychological disorders and should be monitored accordingly.
Full review (3 pages) available for download by subscribers.

In the November issue of Prescrire International:
marketing authorisation for Onsenal° (celecoxib) withdrawn in EU

FREE DOWNLOADAuthorisation was withdrawn after the company failed to supply required data. This example is representative of the drawbacks of the insufficiently demanding marketing authorisation procedure. Also featured on this page: the INN common stem "- conazole".

Full text available for free download.

The Mediator° scandal in France: key dates, key issues

Deaths caused by appetite suppressant Mediator° (benfluorex) made headlines in France last year, igniting a scandal that has led to a broad questioning of the country's medicines policy.

Diabetes: pancreatitis and pancreatic cancers with exenatide and sitagliptin

Exenatide and sitagliptin have adverse effects that are causing increasing concern.

A collective strategy for analysing and preventing healthcare-related adverse events

A collective multidisciplinary analysis of adverse events helps to improve patient safety.

European Medicines Agency's preference for placebo trials is misplaced

It is in the interests of healthcare professionals and patients for new drugs to be compared to existing therapies before being granted a marketing authorisation. However, the European Medicines Agency (EMA) is in favour of placebo-controlled clinical trials.

End of life: optimum pain management

In patients at the end of life, pain management is important for maintaining a certain quality of life.

The 2011 "Prescrire Prize" is awarded in Paris to 5 noteworthy books about health and healthcare

The recipients of the 2011 Prix Prescrire were announced on 6 October 2011. The prize is awarded to works of particular interest to the general public and/or healthcare professionals.

Psychological disorders and treatment of Parkinson's disease:
striking a balance in order to optimise antiparkinsonian treatment

FEATURED REVIEW When a Parkinson's patient presents with a psychological disorder, the first step is to optimise antiparkinsonian treatment by striking a balance between motor control and psychological adverse effects.
Full review (4 pages) available for download by subscribers.

In the October issue of Prescrire International:
Syncope with cholinesterase inhibitors

FREE DOWNLOAD Three cholinesterase inhibitors, donepezil, galantamine and rivastigmine, are widely used as symptomatic treatment of Alzheimer's disease. Their minimal benefits do not justify exposing patients to the risk of syncope and bradycardia, and their consequences. These drugs should simply be avoided and the emphasis placed on non-drug management, however difficult.

Full text available for free download.

European Medicines Agency still lags in providing key documents

Prescrire speaks out in favour of greater transparency, calling upon EMA to provide greater public access to scientific data, as well as information on conflicts of interest.

Methylphenidate and hyperactive children: stunted growth

If methylphenidate slows a child's growth, it may be advisable to halt or adjust the treatment.

Drug packaging: an important factor in the choice of treatment

A drug’s packaging – including the box, the dosing device and the patient information leaflet – is a key factor in its harm-benefit balance.

Child maltreatment through drug or alcohol use

A large number of children are affected by one form or another of maltreatment. One study in the USA found evidence of abuse with psychotropic drugs, analgesics and cardiovascular drugs as well as illegal drugs (marijuana, cocaine, metamphetamine).

France's "AME" programme to cover uninsured foreigners: restrictions contravene medical ethics and are detrimental to public health

In France, the recipients of a government aid programme known as AME ("Aide médicale d’état") must now pay a contribution to benefit from the scheme. This measure serves no financial purpose but restricts access to care and endangers public health.

Skin-lightening cosmetics: frequent, potentially severe adverse effects

FEATURED REVIEW Skin-lightening cosmetics are used by many women and men around the world. Users are often unaware of the risk of severe adverse effects associated with skin-lightening cosmetics. Users should be informed of these adverse effects and encouraged to stop using these products, especially when skin disorders appear.
Full review (7 pages) available for download by subscribers.

In the September issue of Prescrire International:
Does Prescrire's editorial staff have conflicts of interest?

FREE DOWNLOADPrescrire reader and longtime subscriber Francis Blanc learned that one member of Prescrire's editorial team also worked at the French National Authority for Health (HAS). He found this situation "problematic" and felt it could undermine his long-standing confidence in Prescrire...

Full text available for free download.

France's medicines policy: the proposed measures are positive, but need to go further, and above all need to be implemented

The scandal caused in France by the dangerous weight-loss drug Mediator° has resulted in a vast review of the country's medicines policy. Several institutions and official bodies have undertaken a broad debate aimed at proposing improvements in drugs policy.

Nonsteroidal anti-inflammatory drugs (NSAIDs): no routine use of
anti-ulcer drugs

When an NSAID is deemed necessary, it is better to prescribe those with the best risk-benefit balance, at the lowest effective dose and for the shortest period. Anti-ulcer drugs are only warranted when there is a serious risk of severe gastrointestinal adverse effects.

Social justice: a pillar of medical ethics that is often neglected

Given that there is a direct link between socioeconomic inequalities and health inequalities, it is the healthcare professional’s role to combat these inequalities too.

Prescrire's Solidarity Support Programme: helping individuals or organisations in countries with insufficient financial resources.

This Programme helps individuals or organisations whose goals are close to Prescrire’s, in countries with insufficient financial resources. No contributions are accepted from pharmaceutical firms or other sources which may present a conflict of interest.

The 2012 "Prescrire Encounters" to be held 25 and 26 May in Angers, France: working together in the name of better healthcare

The "Rencontres Prescrire 2012" will be held in Angers, France on Friday 25 and Saturday 26 May 2012. The event will be conducted in French, but European and international participants are encouraged to attend, and to contribute their experiences and viewpoints.

France's draft legislation on medicines policy: some progress, but some gaps

The new medicines bill before France’s National Assembly includes some positive measures, especially in terms of transparency and the management of conflicts of interest by regulatory agencies. But several important points are missing, most notably the need to strengthen pharmacovigilance at a local level, and requiring demonstrated therapeutic advance for marketing approval and for reimbursement by the national health insurance system.

Common ailments: building a solid base of knowledge

French journal Prescrire publishes a special issue devoted to the most common ailments.

What if it's the medication?

When confronted with a health problem, it is always useful to question whether the cause might be drug-related.

Drugs' adverse effects: listening to patients improves pharmacovigilance

When patients report adverse drug effects, and healthcare professionals listen to them, there is much to be learned.

Knowing the natural course of a disease makes for better decisions on whether or not to treat

Knowing how a disease is likely to develop in the absence of treatment helps to evaluate whether or not a treatment is useful, and whether its harm-benefit balance is favourable.

Dosing devices: beware of dosing errors

Taking certain precautions helps avoid errors related to dosing devices for oral medication.

Pioglitazone (Actos°): the European Medicines Agency (EMA) fails yet again to be transparent

The European Medicines Agency (EMA) has refused to provide Prescrire with the detailed data in its possession concerning the risk of bladder cancer with pioglitazone (Actos°).

Packaging for non-prescription medicines: the European Medicines Agency needs to rethink the regulations governing self-medication

In its response to the European Medicines Agency's public consultation on draft recommendations for packaging of non-prescription drugs, Prescrire makes the case for stronger regulation to protect the European public.

Medicines policy in France after the benfluorex (Mediator°) scandal:
the proposed measures are positive but still need work, and especially need to be implemented

NEWS ANALYSIS In the wake of France's Mediator° scandal, the country's medicines policy has been broadly called into question. Several institutions have joined in a debate aimed at proposing improvements to this policy. Today it is up to France's political establishment to avoid crushing the hopes that it has raised. What's more, it has an historic opportunity to set a new course in medicines policy, in France and in Europe, first and foremost in the interest of patients

Fingolimod: just another immunosuppressant for multiple sclerosis

FEATURED REVIEW Oral fingolimod appears to be only slightly more effective than interferon beta injections in relapsing-remitting multiple sclerosis, while many potentially serious adverse effects have already emerged. In the absence of anything better, interferon beta remains the best option.
Full review (5 pages) available for download by subscribers.

In the July issue of Prescrire International:
Ivabradine in heart failure

FREE DOWNLOADBeta-blockers used at optimal doses have documented efficacy in heart failure patients. This is not the case for ivabradine, whereas the drug's adverse effects have been confirmed.

Full text available for free download.

Prescrire's freedom to inform is upheld

The French medical journal Prescrire publishes critical information on medicines designed to help healthcare professionals make the best choices. Its right to do so has been upheld by a French court, which rejected a lawsuit by a pharmaceutical company which alleged that Prescrire had "denigrated" one of its products.

Hospital care and medication: frequent fatal adverse events that are often avoidable

A study in the USA has exposed the high frequency and severity of adverse events resulting from hospital care, especially due to medication. Nearly half of these cases could have been avoided.

Flu vaccination for the elderly: a favourable harm-benefit balance

Given the few adverse effects caused by the flu vaccine, the scales tip towards vaccination of the elderly.

Prescriptions using the international nonproprietary name (INN): good practice that is still all too rare in France

In France, too few doctors use the international nonproprietary name (INN) when prescribing drugs.

Subscribers: get the most out of Prescrire online

Paid subscribers can log in to the Prescrire in English website for instant access to every article published in Prescrire International since 1992.

Denosumab: limited efficacy in fracture prevention, too many adverse effects

FEATURED REVIEW In postmenopausal women with osteoporosis, denosumab is probably less effective than alendronic acid for fracture prevention. In contrast, denosumab increases the risk of cancer and infections. A trial of denosumab in men castrated for prostate cancer failed to show any preventive effect on symptomatic fractures, but highlighted the risk of adverse effects.
Full review (4 pages) available for download by subscribers.

In the June issue of Prescrire International: adverse effects of fluoxetine, bevacizumab and venous sclerosants

FREE DOWNLOAD A page selected from the Adverse Effects section this month includes reports on these three types of drug, demonstrating the wide variety of topics covered in Prescrire International.

Full text available for free download.

2010 packaging review: very few improvements and a prevalence of
poor-quality packaging

The overall quality of packaging still remains poor, to the detriment of quality care.

Cancer and end of life: sometimes it is in the patient’s best interest not to treat

Knowing when not to treat with cytotoxic chemotherapy is sometimes the best solution for patients.

Control of adverts for medicinal products in France: opaque and of dubious efficacy

The French Health Products Safety Agency has forced pharmaceutical companies to modify a number of advertisements aimed at health professionals, but there’s no way of knowing which ones.

Osteoporosis: strontium ranelate has too many adverse effects

Alendronic acid is the best treatment for osteoporosis.

Free content online at english.prescrire.org:
What, where, when, how… and why?

Much of this site's content is for Prescrire International subscribers only. But the site was also created to spread awareness about Prescrire’s values, objectives, and way of working, and to help Prescrire and its subscribers to communicate with patients and with the international community.

Prucalopride in chronic constipation: poorly documented risks

FEATURED REVIEW In women complaining of chronic constipation, prucalopride appears to have more risks than benefits: its modest efficacy must be weighed against poorly documented risks, including possible cardiovascular adverse effects and teratogenicity. Prucalopride should simply be avoided in the treatment of constipation, a troublesome but not life-threatening disorder.
Full review (4 pages) available for download by subscribers.

In the May issue of Prescrire International:
Nimesulide - patients still exposed to a risk of severe hepatitis

FREE DOWNLOAD It is unacceptable that nimesulide still remains on the market in France and other countries: reports of severe liver damage continue to accumulate, and many other therapeutic options are available.

Full text available for free download.

Prescrire: transparency and independence

Prescrire is financed solely through subscriptions.

Resistant depression: take adverse effects into account when prescribing treatment

There is still a great deal of uncertainty as to how to deal with persistent depression. The choice of treatment should take adverse effects into account.

Therapeutic patient education: take advantage of the best and steer clear of the worst

Therapeutic patient education is only beneficial to patients if programmes are properly supervised and all those involved remain vigilant to avoid potential abuse.

Poppers: dangerous adverse effects

The use of poppers (amyl nitrite, etc.) as sexual stimulants can result in visual, cardiac, respiratory and blood disorders.

Withdrawal of paracetamol + dextropropoxyphene in France:
about time too

Dextropropoxyphene has adverse cardiovascular effects even in cases of a slight overdose, and especially among the elderly and patients with renal failure. When an opioid is needed, it is better to replace this combination treatment with codeine rather than tramadol.

Prescrire maintains all 5 complaints filed with the European Ombudsman, following the response by the European Medicines Agency (EMA)

Prescrire filed 5 complaints with the European Ombudsman on 30 August 2010, citing repeated refusals by the European Medicines Agency (EMA) to provide documents and information, in particular concerning drugs with a negative risk-benefit balance. After EMA's response in January 2011, Prescrire has decided to maintain all 5 of its complaints.

Upholding ethical standards on comparative evaluation of medicines

The European Medicines Agency has launched a consultation about how new drugs should be compared with existing drugs to obtain marketing approval. Too often a new drug is only compared to placebo, or a non-inferiority trial is used. In a joint communiqué, AIM, the International Society of Drug Bulletins and the Medicines in Europe Forum demonstrate how EMA's stance falls far short not only of the "gold standard", but of the basic ethical principles set out in the Declaration of Helsinki.

Prescrire looks back at new drugs and new indications in 2010:
inadequate assessment; patients at risk

FEATURED REVIEW Prescrire's annual recap of new drugs and new indications reviewed last year in our French edition reveals that almost one-fifth of the new products approved were authorised in spite of a negative harm-benefit balance.
Full review (6 pages) available for free download.

In the April issue of Prescrire International :
Bradycardia due to cholinesterase inhibitors. Identify adverse effects
and take them into account

FREE DOWNLOADWhen an adverse effect has been identified and treated, this information must be shared and taken into account by all those involved in the patient’s subsequent management.
Full text available for free download.

HIV-infected children: few treatments that have been evaluated are both suitable and available

The choice of antiretroviral drugs for children is mostly extrapolated from evaluation in adults. Much progress remains to be made when it comes to the clinical evaluation and adaptation of pharmaceutical forms and fixed-dose drug combinations for children.

Vasodilators: too many fatal cardiac and neurological effects with buflomedil

Offering no proven therapeutic benefits, buflomedil causes sometimes fatal adverse effects. French authorities have finally decided to withdraw it from the market.

Prescrire turns 30

Founded in January 1981 by a group of French physicians and pharmacists, Prescrire is celebrating its 30th birthday.

Prescrire’s proposals to France’s national conference on medicines policy: patients' interests and public health should come first

In the wake of France's Mediator° scandal, Prescrire offers 57 proposals on how to get medicines policy back on course.

Astellas' lawsuit against Prescrire: French court rules that Prescrire did not "denigrate" Protopic° (tacrolimus)

A Paris court handed down its ruling on Wednesday 2 March, rejecting a suit brought by pharmaceutical company Astellas against the French journal Prescrire. At a time when French society is reeling in the wake of the scandal caused by weight-loss drug Mediator° (benfluorex), the 2 March ruling comes as very good news for healthcare professionals and for patients.

Preventing neonatal Group B streptococcal infection :
Intrapartum antibiotic prophylaxis in some high-risk situations

FEATURED REVIEWGroup B streptococci are the leading cause of life-threatening neonatal bacterial infections in developed countries. The first priority in prevention is to identify situations in which there is a high risk of neonatal infection, and to administer antibiotics during labour, after screening for GBS carriage, if possible.

Full review (6 pages, 29 references) available for download by subscribers.

In the March issue of Prescrire International:
Selected reports from the 31st French Pharmacovigilance Meeting

FREE DOWNLOAD The 31st French Pharmacovigilance Meeting took place in March 2010 in Bordeaux. Among the reports presented, the results of a French study on Inhibition of lactation, revealing the risks associated with dopamine agonists.

Prescrire's review of one such report is available for free download.

The 2010 Prescrire Drug Awards: significant progress in 2010,
but only for a few patients

The 2010 Prescrire Awards include 1 drug placed on the "Honours List", 2 others deemed "noteworthy", but none worthy of Prescrire’s "Pilule d’Or" ("Golden Pill").

Prescrire's 2010 Information Awards: a few companies are praised for their transparency, but others receive "Red Cards"

In addition to a drug's effectiveness, adverse effects, convenience and price, the pharmaceutical company’s transparency is a criterion to be taken into account when choosing a treatment.

Prescrire's ratings system: gauge the usefulness of new products at a glance

Since its creation 30 years ago, Prescrire has used a rating system to provide an at-a-glance estimate of the therapeutic progress (or lack thereof) of the new drugs and indications analysed each month.

Arterial hypertension: too many disadvantages with fixed-dose drug combinations

When a correctly followed anti-hypertensive treatment with a single drug proves ineffective, the combination of 2 even 3 anti-hypertensive drugs is sometimes successful, but it is better to avoid fixed-dose combinations.

Localised prostate cancer: inform patients of the long-term effects of various treatments

The treatments for localised prostate cancer vary in terms of how they affect a patient’s quality of life. Patients should be informed of these effects.

Type-2 diabetes: don’t aim for blood pressure that is unnecessarily low

Aiming for a systolic blood pressure below 120 mm Hg, rather than 140 mm Hg, is of little benefit in preventing cardiovascular complications and exposes patients to the risk of serious adverse effects.

Drugs placed on a watchlist by the French medicines agency:
Prescrire's analysis

At a press conference in Paris on 1 February 2011, Editorial Director Bruno Toussaint outlined Prescrire's position regarding the list of 77 drugs placed on a watchlist by France's medicines agency (Afssaps).

The results of the 2010 Prescrire Awards announced in Paris at
Prescrire's annual "Pilule d'Or" ceremony

On 27 January 2011, Prescrire presented the 2010 Prescrire Awards at the annual "Pilule d'Or" ("Golden Pill") ceremony in Paris. Prescrire's Drugs, Information and Packaging Awards were presented, followed by a debate on the theme of "Comparisons enable better treatment - evaluating therapeutic advances in patients' best interests".

Saxagliptin: no more effective than other gliptins, but a high potential for drug interactions

FEATURED REVIEW In patients with type 2 diabetes in whom metformin or glibenclamide monotherapy fails, saxagliptin is no safer or more effective than other gliptins. It has a worse safety profile, with many long-term uncertainties and a high potential for drug interactions. It is better to continue with better-assessed treatment strategies.

Full review (5 pages) available for download by subscribers.

In the February issue of Prescrire International:
deaths from benfluorex (Mediator°) + new data on dextropropoxyphene

FREE DOWNLOAD The appetite suppressant benfluorex (Mediator°) was withdrawn from the French market in 2009. The drug is currently the subject of intense controversy, sparked by a study from French health authorities, the findings of which are reported here. Sharing the same page from Prescrire's "Adverse Effects" section, an update on dextropropoxyphene, another dangerous drug finally on the way out in France.
Full reviews available for free download.

Monitor blood pressure during pregnancy

High blood pressure during pregnancy requires rest, and possibly medication, preferably with labetalol or nifedipine.

Oral contraception: reduce the risk of deep vein thrombosis

For women requiring a combined oestroprogestative oral contraceptive, the best options are ethinylestradiol + levonorgestrel or ethinylestradiol + norethisterone.

France's Mediator° scandal: take the high road

NEWs ANALYSIS The public health fiasco caused in France by Mediator° (benfluorex) has revealed grave deficiencies in the regulation of a drugs market that is under intense pressure from the pharmaceutical industry. This disaster also brings an historic opportunity to improve public health and to refocus priorities in pharmaceutical policy on patients' interests.

Adverse effects of cannabis: inform psychologically vulnerable patients of the risk of serious, dose-dependent disorders

FEATURED REVIEW The adverse effects of low-level, recreational cannabis use are generally minor, although they can apparently be serious in vulnerable individuals. The adverse effects of cannabis appear overall to be less serious than those of alcohol, in terms of neuropsychological and somatic effects, accidents and violence.
Full review (6 pages) available for download by subscribers.

In the January issue of Prescrire International:
Domperidone - QT prolongation in infants

FREE DOWNLOAD A French study of 31 newborns and infants receiving domperidone showed statistically significant QTc prolongation. These data confirm that domperidone should not be used to treat mild regurgitation in infants.

Full text available for free download.

Neuroleptics: potentially serious swallowing disorders

Swallowing disorders in a patient on neuroleptics could be caused by the medication.

Classification of mental disorders: beware of a dangerous trend

The upcoming draft of the DSM, published by the American Psychiatric Association and followed around the world, represents another step toward the medicalisation of emotions and of life.

Fraud by pharmaceutical companies: hit them in the wallet!

In the USA, a firm convicted of promoting a drug for indications other than those authorised has been fined more than 500 million dollars.

Mediator°: a book that spells trouble for one drug company

An exemplary book detailing a doctor’s battle against a dangerous drug.

Final proposals on pharmacovigilance: Some progress, but a missed opportunity to genuinely strengthen patient safety

In a joint communiqué, HAI Europe, the Medicines in Europe Forum and the International Society of Drug Bulletins analyse the pharmacovigilance proposals that were adopted by the Ministers for Health of the Member States on 29 November 2010.

Acute poisoning following ingestion of medicines: initial management

FEATURED REVIEW This review examines the initial management of patients with suspected acute poisoning, based on a review of the literature using the standard Prescrire methodology. It addesses the key issues of how to treat life-threatening complications and to evaluate the risk of delayed effects and psychological distress.
Full review (8 pages) available for download by subscribers.

In the December issue of Prescrire International:
Tibolone and breast cancer: evidence of increased risk

FREE DOWNLOAD Tibolone increases the risk of breast cancer and stroke. It is better to avoid it.
Full text available for free download.

"Mental health", emotions, psychological pain: just what are we trying to treat?

At the annual Prescrire Prize ceremony, a debate on the role of “mental health” and psychoactive medications in our society.

Type-2 diabetes: promote a Mediterranean diet

For overweight patients with recently discovered type-2 diabetes, a low-carbohydrate Mediterranean diet helps reduce blood-glucose levels.

Resumption of bowel movements after abdominal surgery is speeded up by chewing-gum

Chewing gum seems to be a simple way to speed up the resumption of bowel movements after abdominal surgery, and can even shorten a patient’s stay in hospital, with no major adverse effects.

Breast cancer: exercising the upper arm in cases of lymphoedema

In women suffering from lymphoedema after breast cancer surgery, regular exercise of the upper arm increases its muscle strength with no serious adverse effects.

Towards direct-to-consumer advertising for prescription drugs?
The autumn will be crucial (continued) (November 2010)

The European Commission's original proposals, though improved by the Members of the European Parliament, are still of little benefit and some provisions are even detrimental. Read on...

Maraviroc as first-line therapy for HIV infection: too risky

FEATURED REVIEW Clinical assessment of maraviroc in first-line therapy for HIV infection was not designed to show a therapeutic advantage over other first-line combinations. Maraviroc belongs to a new class of antiretroviral drugs, but the test used to identify viruses that are susceptible to this drug is unreliable. Its adverse effects are poorly documented. Maraviroc should continue to be reserved for patients with multiple treatment failure.
Full review (3 pages) available for download by subscribers.

In the November issue of Prescrire International:
Ulipristal and postcoital contraception (letter and response)

FREE DOWNLOAD In a letter to Prescrire's editors, André Ulmann, President of the monitoring committee for the firm HRA Pharma, protests against Prescrire's article on EllaOne° (ulipristal), but fails to cite so-called errors and omissions in Prescrire's assessment.
The full text of Ulmann's letter (Prescrire's translation) and the editors' response are available for free download.

Primary cardiovascular prevention: in the absence of risk factors, aspirin is not advisable

Aspirin has a very limited role to play in primary cardiovascular prevention. A Mediterranean diet, stopping smoking, and the control of risk factors (hypertension and hypercholesterolaemia) are the best preventive measures.

Fluindione: warfarin is a better option

When an oral anticoagulant is required, it is better to opt for one with a favourable risk-benefit balance such as warfarin. Fluindione should be avoided.

Nicorandil: stop!

The angina drug nicorandil should be banned due to its negligible efficacy and potentially severe toxicity.

Prescrire International is now published 11 times a year

In an international scene more and more dominated by continuing medical education that is financed by pharmaceutical companies – and more generally by information that is under the influence – monthly publication will reinforce Prescrire International’s role as a critical voice in the European medicines market, and as a reliable source of independent continuing education for healthcare professionals.

The 2010 Prescrire Prize: not just another book award

On 7 October, the Prescrire editorial staff announced the winners of the 2010 Prescrire Prize. The 2010 Prize was awarded to 5 books of interest to the general public and/or healthcare professionals. The Jury selected the winners from among the works reviewed in issues 312 (October 2009) to 323 (September 2010) of La revue Prescrire.

Drug-induced acneiform rash

FEATURED REVIEW Acne is a generally mild skin condition, common among adolescents and young adults. Certain toxins and drugs can aggravate pre-existing acne or cause acneiform rash. Various pharmacological classes can cause acneiform rash. The eruptions usually subside after drug withdrawal, but sometimes only after several months.
Full review (3 pages) available for download by subscribers.

In the October issue of Prescrire International:
ketoprofen gels, unfortunately back on the French market

FREE DOWNLOAD Ketoprofen gels are more harmful than beneficial, and their withdrawal from the French market in late 2009 was a welcome measure. Unfortunately, they were back on the market in early 2010 following legal action. Healthcare professionals and patients should rely on solid evidence rather than decisions made by regulatory agencies or the judiciary.

Full text available for free download.

Parecoxib and fatal skin reactions: when will this drug be withdrawn from the European market?

The risk-benefit balance of cox-2 inhibitor anti-inflammatories is unfavourable. The European Medicines Agency has merely indicated the risk of a potentially fatal skin reaction with parecoxib, instead of demanding its withdrawal from the market.

Research organisations: misleading press releases

Journalists writing for the consumer press should be wary of press releases from research organisations and researchers as they are often biased.

Reporting of errors by healthcare professionals: a source of information that is useful in improving patient care

It is not easy to report errors. Prescrire urges healthcare professionals to do so, to help others prevent the same errors.

Fatal hepatitis with nimesulide: the European Commission drags its feet

Rather than withdrawing nimesulide from the market, the European Commission is gathering reports of liver transplants.

Elderly patients with dementia: avoid neuroleptics if possible

Neuroleptics have an unfavourable risk-benefit balance for elderly patients with dementia.

Anaesthetic creams used cosmetically: risk of death as a result of overdose

Anaesthetic creams sometimes cause severe, even fatal, adverse effects when they are applied to large areas of skin.

Pharmaceutical companies' "sales reps": not to be relied on when it comes to quality of care

The French National Authority for Health (HAS) has made it clear to the healthcare community that it cannot control sales reps’ visits, which are a key means that pharmaceutical companies use to promote their products.

Cardiorespiratory arrest: resuscitate as quickly as possible without unreasonable obstinacy

In the event of cardiorespiratory arrest, the rapid application of resuscitation procedures determines the chances of survival without neurological after-effects.

Dextropropoxyphene + paracetamol to be withdrawn from the European market by September 2011 at the latest

The European Commission has decided to withdraw dextropropoxyphene-based drugs from the market by mid-September 2011 at the latest.

Direct-to-consumer advertising for prescription drugs: appeal to members of the European Parliament

MEPs must transform the European Commission’s dangerous proposals into progress for patients.

Rosiglitazone (Avandia°; and in combination with metformin in Avandamet°): a market withdrawal that has been 8 years in coming

The European Medicines Agency recommended on 23 September 2010 that rosiglitazone be withdrawn from the market. Yet the data published in 2010 have only confirmed the risks that were apparent as soon as rosiglitazone came onto the market in 2002.

Cervical cancer screening: organised screening to avoid unnecessary conisation

FEATURED REVIEW The incidence of cervical cancer and related deaths has fallen gradually since 1970 in several European countries. This article examines the role of screening in this reduced mortality, and the potential harms of cervical screening, based on a review of the literature using the standard Prescrire methodology.

Full review (8 pages) available for download by subscribers.

Poliomyelitis: spreading in Africa

Poliomyelitis has been eradicated in Europe since 2002, but has been on the increase in Africa since 2006. Vaccination of the entire world population remains a necessity.

Prescrire files a complaint against the European Medicines Agency (EMA)

Prescrire has filed a complaint with the EU Ombudsman, citing the European Medicines Agency’s repeated refusals to supply documents and information, particularly regarding drugs with an unfavourable risk-benefit balance. The complaint details 5 particularly unacceptable cases.

Treatment decisions: empowering patients

The patient's illness ought to be the core concern. Patients should be involved in the treatment, alongside healthcare professionals.

Treating hypertension: blood pressure targets should be tailored to each patient

In patients without diabetes or cardiovascular complications whose blood pressure is above 160/95 mm Hg, the usual goal of treatment is to reduce the blood pressure to below 140/90 mm Hg. But this should be adjusted in light of the patient’s clinical circumstances and preferences, since numerous trials have shown that reducing blood pressure even to 150/90 mm Hg is beneficial.

Combating socioeconomic inequalities to improve health

Inequalities in living conditions result in health inequalities. Improving health depends up on reducing these inequalities.

Vitamins and minerals: ineffective in preventing cancer and cardiovascular disease

No vitamin or mineral supplement has a proven benefit in preventing cardiovascular disease or cancer in adults in developed countries.

The hidden cost of poor-quality healthcare

Choosing the treatment with the best risk-benefit balance and eradicating harmful treatments is an individual and collective challenge.

For quality healthcare, free healthcare professionals and the health authorities from the influences that hinder them from acting in patients' best interests

The influence exerted by healthcare products manufacturers on the health sector is jeopardising the quality of care.

Access to healthcare: patients' individual needs should be taken into account

Being aware of patients’ specific difficulties makes it possible to improve their access to healthcare.

Dronedarone in atrial fibrillation: too many questions about long-term adverse effects

FEATURED REVIEW In patients with atrial fibrillation, dronedarone has less antiarrhythmic efficacy than amiodarone but fewer short-term adverse effects. Little is known of potential long-term adverse effects, but dronedarone has been linked to increased mortality in patients with heart failure. When antiarrhythmic drug therapy is needed, it is better to continue to use a beta blocker or, as a last resort, amiodarone, a drug with better-documented adverse effects, especially during long-term treatment.

Full review (4p) available for download by subscribers.

In the August issue of Prescrire International: Lyell syndrome and epileptic seizures due to confusion between Lamictal° and Lamisil°

FREE DOWNLOADErrors with serious consequences have resulted from confusion between the brand names Lamictal° and Lamisil°. Such errors have been reported in France and elsewhere for over 10 years, and continue to occur. To think, prescribe, and dispense drugs using the international nonproprietary name (INN) first could help prevent confusion between brand names.

Full text available for free download.

Subscribers, register now to receive your new online access codes

The Prescrire in English website has a new system, featuring a powerful search engine covering Prescrire's entire database of articles in English. To take full advantage of the new features, you will need to register online or confirm your registration.

Fears of increased medical litigation in France often exaggerated

French healthcare professionals are worried about increased litigation. This fear is created more by huge increases in insurance premiums than by a massive rise in the number of claims.

Conflicts of interest at the French drug regulatory agency:
progress too slow

Transparency in declaring experts’ connections with pharmaceutical companies is essential. But it is not sufficient to guarantee the impartiality of the agency’s decisions.

No authorisation for etoricoxib!

The harm-benefit balance of cox-2 inhibitor anti-inflammatory drugs is unfavourable. It is inexcusable for a new cox-2 inhibitor to have been authorised for sale and reimbursement in France.

Restless legs syndrome: can be caused by medication

Some drugs can cause or exacerbate restless legs syndrome. Reducing the dosage or halting the suspected drug often results in an improvement for the patient.

Marketing of pharmaceutical products: nurses now being targeted too

As nurses’ responsibilities expand to include the prescription of medical devices, pharmaceutical companies’ marketing strategies are increasingly targeting them.

Drugs reimbursed at 15%: inconsistencies in French policy

It is unacceptable to continue paying for drugs – even at the reduced rate of 15% – when their medical benefit rating is insufficient or their risk-benefit balance is negative.

Delisting in France of certain poorly effective drugs challenged by drug companies

Several pharmaceutical companies have succeeded, via a process which has not been revealed to the public, in securing the continued reimbursement of their drugs by France’s national health insurance system.

INR self-monitoring and oral anticoagulants

FEATURED REVIEW It appears that oral anticoagulant therapy can be optimised by INR measurement at least every two weeks, with immediate dose adjustment. INR self-measurement can help to ensure that these conditions are respected.
Full review (3p) in English available for download by subscribers.

Benfluorex (Mediator° or other brands): marketing authorisation withdrawn throughout the European Union

After years of dithering, Benfluorex’s European marketing authorisation has at long last been withdrawn, due to the drug’s serious adverse cardiovascular effects (valve damage in particular).

Smokers: no beta-carotene supplements

Beta-carotene supplements increase the risk of lung cancer in smokers, contrary to expectations.

Sibutramine: withdrawn from the European market at last!

Sibutramine is an amphetamine-based appetite suppressant with an unfavourable risk-benefit balance due to adverse cardiovascular effects.

Intramuscular injections: how to avoid adverse effects

Simply choosing the best injection site and the right needle helps reduce the risk of adverse effects from an intramuscular injection.

Arterial hypertension: sometimes caused by alcohol

Alcohol consumption raises blood pressure. It can also account for resistance to antihypertensive drugs.

Mean, median and mode: tools to enlighten patients

Healthcare professionals can use mean, median and mode observed during studies or trials to explain the expected outcome of treatment to patients in simple language.

EMA's policy on conflict of interest: improvements needed (June 2010)

In an open letter, ISDB and Medicines in Europe Forum (MiEF) draw the attention of the European Medicines Agency (EMA)’s executive manager to the need for the EMA to better implement its own basic rules on conflict of interest notably at the management board level. They also share more general comments on the need for the EMA to strengthen its policy on the conflict of interest of experts working with the Agency. Read on...

Liraglutide in type 2 diabetes: more prudent to continue using exenatide

FEATURED REVIEW Liraglutide has no advantages over exenatide in terms of the clinical complications of diabetes, weight loss, nausea after initiation of treatment, or the risk of pancreatitis. It is more prudent to continue using exenatide.
Full review (4p) in English available for download by subscribers.

In the June issue of Prescrire International:
Neuropsychological effects of macrolides

FREE DOWNLOADMacrolides can provoke neuropsychological adverse effects such as hallucinations, delirium, manic episodes and sometimes depression, in both adults and children.
Full text available for free download.

Prescrire's accounts: independence is possible

Financed solely through subscriptions, Prescrire is an information and training organisation that is fully independent, both from pharmaceutical companies and from health authorities. This financial independence is essential in order to maintain true independence of thought.

Direct-to-consumer advertising for prescription drugs: the European Commission persists

The Commission proposes to ease the ban on direct-to-consumer advertising for prescription drugs.

Automatic external defibrillators can save lives

The risk-benefit balance of automatic external defibrillators is favourable when they are used properly by trained people who follow correct procedures.

European Medicines Agency: more independence is needed

HAI Europe, ISDB and the Medicines in Europe Forum have jointly answered the EMA’s public consultation on its road map to 2015. They decry a number of practices that create conflicts of interest, and argue that the Agency’s financial and intellectual independence from pharmaceutical companies should be the priority if the EMA is to improve its accountability to citizens.

Visual disorders: sometimes drug-related

Visual disorders, such as myopia, hypermetropia and loss of the accommodation faculty (presbytia), are often caused by anatomical anomalies or ageing. However, they can sometimes be caused by medication, and in these cases are reversible when treatment stops.

Palliative care: the perverse effects of funding

Standardised hospital charges are not ideal for promoting quality palliative care.

France's "dossier pharmaceutique": patient information shared between pharmacists

Electronic files can contribute to the quality of care by giving a history of all drugs dispensed to the same patient from all pharmacies.

Formaldehyde: a new occupational disease recognised

Cancer linked to exposure to formaldehyde (alias formol in its aqueous form) has been recognised as an occupational disease.

Digoxin: serious drug interactions

FEATURED REVIEW Digoxin has a narrow therapeutic margin and frequent and potentially severe adverse effects. Close clinical monitoring is necessary to detect early warning signs. Special care is required for patients with renal failure, the elderly and patients receiving potentially interacting drugs.
Full review (3p) in English available for download by subscribers.

Statins: tendon damage rare but sufficient to warrant monitoring

Tendon damage caused by statins seems to be rare but warrants clinical monitoring during the first year of treatment, especially when there are risk factors.

Prescrire looks back at 2009: too little improvement and too many backward steps

The results of Prescrire's wrap-up of new drugs reviewed in 2009 are meagre and worrying.

Depression in children and adolescents: a few pointers for improved care

Carefully observing and listening attentively to children and those around them are vital for identifying depression and providing appropriate solutions.

Direct-to-consumer communication by pharmaceutical companies? Europeans deserve better

A joint press release from 29 organisations outlines proposals to improve access to independent and comparative health information.

Prescrire's 2009 drug review: a major sorting operation

Prescrire's annual review enables healthcare professionals to update their range of treatments and improve patient care, based on independent information.

Oral contraceptives: opt for tried-and-tested combinations rather than latest-generation pill

Levonorgestrel- or norethisterone-based combinations of oestrogen and progestogen are the first-choice oral contraceptives, because of their more favourable risk-benefit balance.

Pregnant women: continue to screen for syphilis

Routine screening of pregnant women for syphilis allows treatment and helps reduce the incidence of congenital syphilis.

Trimetazidine: unfavourable risk-benefit balance confirmed

Despite a markedly unfavourable risk-benefit balance, trimetazidine is still on the market in France for various situations.

Self-medication: "umbrella" brands with misleading names persist

"Umbrella" brands, which cover drugs with different compositions under a single brand name, are a potential source of patient error. But driven by pharmaceutical companies' marketing strategies, these brands are enjoying a growing presence in the self-medication market.

Ulipristal for postcoital contraception: no better than levonorgestrel

FEATURED REVIEW There is no firm evidence that ulipristal is more effective than levonorgestrel when used for postcoital contraception up to 5 days after intercourse. Similarly, ulipristal does not appear to be any safer than levonorgestrel. It is therefore better to continue to use levonorgestrel, a better-assessed drug.
Full review (3p) in English available for download by subscribers.

In the April issue of Prescrire International:
Telithromycin: visual disorders

FREE DOWNLOAD Visual disorders reported in a Finnish pharmacovigilance review add yet another reason to opt for a safer macrolide, such as spiramycin.
Full text available for free download.

Prescrire's annual Drug Awards: just two minor improvements in 2009

No "Pilule d'Or" ("Golden Pill") and no drugs placed on the "Honours List" in Prescrire's 2009 Drug Awards.

Prescrire's Packaging Awards: some improvements in 2009

All too often drug packaging is neglected by pharmaceutical companies and drug regulatory agencies.

Transparency in the pharmaceutical industry: Prescrire's 2009 Information Awards

Prescrire rewards the companies that act responsibly by making their full data available to the editorial staff, and reminds companies failing to do so that releasing this information is in patients' best interests.

Compare before deciding: Prescrire's annual review of new drugs

As always, Prescrire's year-end drug review provides impartial comparisons to help healthcare professionals sift through all the "innovations".

Acute rhinosinusitis in adults: antibiotics should not be prescribed from the outset

In adults presenting a moderate maxillary rhinosinusitis, with no particular risk of infection, complications are rare and there is no need for antibiotic treatment.

Acne: new measures concerning isotretinoin

In view of the major risk of fetal malformation, new measures have been introduced in France concerning the prescription of isotretinoin for women.

Self-medication: no to product ranges with misleading names

"Umbrella" brands include several medicinal products with different compositions and for different indications under the same brand name. A commercial practice that can result in patient medication error.

France's "long-term ailments" system: increased costs anticipated

France's full coverage for "long-term ailments" is not just another budget item, to be cut by any means possible.

Dapoxetine to treat premature ejaculation: not worth the risk

FEATURED REVIEW The four available placebo-controlled trials show that only a minority of couples perceive an improvement in their sex life due to a specific effect of dapoxetine on the time to ejaculation. In contrast, dapoxetine exposes men to the potential adverse effects. Psychobehavioural approaches should remain the cornerstone of treatment.
Full review (3p) in English available for download by subscribers.

Meprobamate (Equanil°): watered-down half-measures are not enough

The risk-benefit balance of meprobamate is unfavourable. Withdrawing it definitively from the market would be the best way of protecting patients.

MRI findings of meniscal damage in over-50s: frequent, but often asymptomatic

When MRI scans are carried out on people aged over 50, it is common to observe damage with no associated symptoms.

Heartburn: pantoprazole in some cases, but not during pregnancy

For some patients who suffer from heartburn, pantoprazole can be used. It is best avoided during pregnancy.

Atomoxetine: no better than methylphenidate in treating attention deficit-hyperactivity disorder

FEATURED REVIEW In children with attention deficit-hyperactivity disorder, two clinical trials showed that atomoxetine is probably less effective and no better tolerated than methylphenidate. It is better to continue to use methylphenidate for the few patients who really need drug therapy.
Full review (4p) in English available for download by subscribers.

In the February issue of Prescrire International:
drug-related memory loss; carbimazole and birth defects

FREE DOWNLOAD Two texts from the February "Adverse Effects" section. Dementia is not the only cause of memory loss : a drug-related cause should always be investigated, as revealed by data from France's regional pharmacovigilance centres. And reports of birth defects mean that it is better to use propylthiouracil rather than carbimazole to treat hyperthyroidism during pregnancy.
Full texts available for free download.

Prescrire's 2010 "Pilule d'Or" ceremony held in Paris:
the 2009 Prescrire Awards

At the annual "Pilule d'Or" ("Golden Pill") ceremony in Paris on 28 January 2010, Prescrire's editors announced the results of the 2009 Prescrire Drug, Packaging and Information Awards. The awards ceremony was preceded by a Conference-Debate on the subject of the adverse effects of drugs.

Too many pregnant women are exposed to contraindicated drugs

Many drugs are harmful to the unborn child. It is important to know what these are to avoid exposing pregnant women and fetuses.

Financing of patient groups must be clarified

Patients need independent groups to defend their interests. There is a clear conflict of interest when patient groups are funded by pharmaceutical firms.

Diabetes: monitor blood glucose levels and blood pressure, and check eyes regularly

Preventing blindness in diabetic patients requires monitoring blood glucose levels and blood pressure as well as regular eye check-ups.

Administering drugs to children: frequent errors

Administration of drugs to children by their parents is welcome in some cases, provided they check the composition of the medication, and the dosage.

Fentanyl patches: risk of fatal overdose

Fentanyl is a powerful analgesic. Due to the risk of overdose, precautions must be taken in using and disposing of fentanyl patches.

Bronchiolitis in infants: parents should exercise caution, but should not panic

This is a new entry in Prescrire's "Fiches Infos-Patients" series, which delivers information designed for healthcare professionals to pass along to their patients.

Evaluating drug risks: scientific evidence and case specifics must be taken into account

Three factors influence drug risk evaluations: evaluation data on the drug, pharmacological data, and the specifics of each patient’s case.

Assessing environmental health risks: managing uncertainty

Risk assessment is necessary in order to anticipate and reduce the health impact of exposure to various agents present in the environment. Managing the complexity and uncertainties requires transparency and consistency.

Valproic acid: long-term effects on children exposed in utero

FEATURED REVIEW Numerous follow-up studies show that valproic acid is more teratogenic than other antiepileptics. The use of valproic acid should be avoided throughout pregnancy, as well as by women of child-bearing age not using effective contraception.
Full review (4p) in English available for download by subscribers.

Pregnancy: no iron supplements if there is no anaemia

Excessive iron supplements taken by pregnant women increase the risk of premature birth, of hypotrophy of the newborn and hypertension in the mother.

Complex regional pain syndrome type 1: treatments ineffective

Pain-relieving drug and non-drug treatments may be offered to patients suffering from complex regional pain syndrome type 1, but they are not very effective. Others are to be avoided, as they are ineffective or even harmful.

French health authorities drag their feet: the example of nonsteroidal anti-inflammatories

Despite an unfavourable harm-benefit balance, two nonsteroidal anti-inflammatories, celecoxib and piroxicam, are still on the market in France — for the benefit of the pharmaceutical companies, and to the detriment of patients.

European Commission places medicines under DG-SANCO's competence

The President of the European Commission, José Manuel Barroso, has decided to transfer the management of pharmaceuticals and medical devices policies from the Directorate General-Enterprise (DG-E) to the DG-SANCO (Health and Consumer Policy).

H1N1 flu: vaccinate those at risk and those around them

Vaccination against H1N1 flu is advisable for those at risk of complications (especially pregnant women and infants), the people around them and those who take care of them.

H1N1 flu: mild severity confirmed

In mainland France at end November 2009, nearly 4 million people have had the H1N1 flu. There has been approximately 1 death per 40,000 cases of H1N1 flu. 8 out of 10 complications occurred in persons with known risk factors.

Multiple sclerosis: still no evidence that glatiramer is any more effective than interferon beta

In patients suffering from relapsing remitting multiple sclerosis, the reference treatment, for lack of anything better, is interferon beta, which reduces the number of relapses but does not diminish the worsening of disability.

Health and genetics: beware of over-simplification

Diseases that are highly genetically determined are rare. Most diseases have multiple causes. The association of diseases with genes does not necessarily mean that the cause is genetic.

Benfluorex: the appetite-suppressant amphetamine is finally suspended from sale in France

NEWS UPDATEBenfluorex's negative risk-benefit balance has been known for years. It took until late November 2009 for the French Health Products Safety Agency (AFSSAPS) to finally suspend its marketing authorisation.

Agomelatine for major depression in adults: adverse effects and no proven efficacy

FEATURED REVIEW Agomelatine, a melatonin receptor agonist, is approved in the European Union for the treatment of depression. Agomelatine has unproven efficacy and poorly documented adverse effects. It is better to continue to use older antidepressants such as tricyclics or selective serotonin reuptake inhibitors.
Full review (4p) in English available for download by subscribers.

In the December issue of Prescrire International:
Pantoprazole in gastroesophageal reflux

FREE DOWNLOAD Pantoprazole, available without a prescription for the symptoms of gastroesophageal reflux, has a better risk-benefit balance than H2 receptor antagonists, but should not be used by pregnant women.
Full text available for free download.

Pharmacovigilance in Europe: soon to be placed in the hands of pharmaceutical companies?

The European Commission is proposing to entrust pharmaceutical companies with the post-marketing monitoring of their own drugs – entailing the risk that firms will cover up evidence of adverse effects that might harm sales.

H1N1v flu vaccines
(Celvapan°, Focetria°, Pandemrix°, Panenza°)

Vaccinate people with a high risk of severe complications, and choose the vaccine best suited to each individual. Not all H1N1v vaccines are created equal, and their usefulness differs according to several factors.

Nimesulide: a nonsteroidal anti-inflammatory that can cause fatal hepatitis

When a nonsteroidal anti-inflammatory is necessary, it is best to avoid nimesulide in favour of another drug with a better risk-benefit balance.

Flu prevention: first and foremost, wash hands often

When infection must be avoided: frequent hand-washing, and surgical masks for patients.

More on the H1N1 flu: the truth about antivirals, and the risks for pregnant women and infants

Prescrire reports that antivirals should not be relied upon in combating the H1N1 virus, and summarises strategies for limiting the risks for pregnant women and infants.

Psoriasis in children: natural outcome often positive

Topical treatment of the symptoms is usually sufficient. Treatments with severe adverse effects should be avoided as far as possible.

The 2010 "Prescrire Encounters" in Brussels:
"For accessible quality healthcare"

The "Rencontres Prescrire 2010" will be held in Brussels Friday 28 and Saturday 29 May. The event will be conducted in French, but a broad range of European and international participants and viewpoints are expected, and encouraged.

Prasugrel after angioplasty and stenting: continue to use aspirin + clopidogrel

FEATURED REVIEWThe best-assessed treatment for preventing relapses is a combination of aspirin and clopidogrel. Whereas prasugrel, in one trial, was no more beneficial than clopidogrel in reducing mortality and increased the risk of bleeding and other serious adverse effects.
Full review (3p) in English available for download by subscribers.

Dealing with the H1N1 flu virus: step by step

As of October 2009, the H1N1v flu virus has barely spread in France, but things are still feverish as regards vaccines. Many of the questions still have no clear answers. Contradictory information is swirling around every which way. And probably disinformation as well.

Medicines: time to come clean

Transparency is the latest buzzword. But health agencies, the health industry and their intermediaries do not practise it.

Routine screening for prostate cancer is not justified

In 2009, the value of routine screening for prostate cancer has not been clearly proven, but its adverse effects have.

Pharmaceutical companies: anti-competitive practices jeopardise research

Pharmaceutical companies are using every trick in the book to delay competition from generics or new drugs.

2009 "Prix Prescrire" book awards announced

On 1 October, the French journal Prescrire announced the winners of its annual book award, the "Prix Prescrire". Four books in French were singled out by Prescrire’s Editorial Staff for the quality, impartiality and usefulness of their information.

Drugs' brand names are a source of confusion

The European Medicines Agency (EMEA) is allowing pharmaceutical companies to develop sales strategies based on drugs' brand names, at the risk of creating confusion for patients.

Type 2 diabetes: diet is important but should not be rigid

In type 2 diabetes patients, losing weight and adopting a "Mediterranean" diet, without being totally inflexible, reduces cardiovascular events and increases life expectancy.

Cough and cold medicines: some should be avoided

Cough and cold remedies have little effect and are little – if at all – better than a placebo. Some expose patients, children in particular, to severe and disproportionate adverse effects.

Prescrire's "Fiches Infos-Patients": reliable information for patients

Reliable, independently produced and regularly updated, Prescrire's new patient-information feature will help subscribers to get patients actively involved in decisions concerning their care.

Renal colic in adults: NSAIDs and morphine are effective for pain relief

FEATURED REVIEW After having considered other diagnoses and checked for signs of complication, the first step in treating renal colic is to control the pain. Which non-invasive treatments have a positive risk-benefit balance? We review the available evidence, based on standard Prescrire methodology.
Full review (5p) in English available for download by subscribers.

In the October issue of Prescrire International:
Fewer adverse effects with doxycycline than with minocycline

FREE DOWNLOADA French pharmacovigilance report reveals more frequent adverse effects and a higher proportion of severe adverse effects with minocycline than with doxycycline.
Full text available for free download.

Avoid errors in drug names: use the international nonproprietary name

Using a drug’s international nonproprietary name (INN) is particularly helpful in avoiding confusion between similar brand names.

H1N1 flu virus: moderate severity

Experience acquired around the world indicates that the H1N1 flu is of similar clinical severity to that of bad seasonal flu outbreaks.

H1N1 flu: keep cool

The political and media frenzy around the H1N1 pandemic is disproportionate, given the flu's only moderate severity.

Medications sometimes result in often preventable hospital admissions

Over the past decade, the number of patients admitted to hospital in France for adverse effects associated with drug treatments has not decreased. There are lessons to be learned and improvements to be made.

Etoricoxib: no to a drug with an unfavourable risk-benefit balance

Despite its unfavourable risk-benefit balance, etoricoxib, a nonsteroidal anti-inflammatory drug, is set to be marketed in France.

Cannabis: limited therapeutic benefit

Only one orally administered cannabis derivative, THC, is effective in providing a little relief from some pains associated with multiple sclerosis, at the cost of sometimes serious neuropsychological effects.

Food colouring increases hyperactivity in children

Some food colourings seem to increase activity in children diagnosed as hyperactive, but the same appears to apply to children not diagnosed as hyperactive. It is better to avoid exposing any children to food colourings.

European medicines agency: lack of transparency

The European Medicines Agency (EMEA) is reluctant to publish vital documents relating to drugs, in order to protect pharmaceutical companies' interests.

Fibromyalgia: poorly understood;
treatments are disappointing

FEATURED REVIEWSymptoms include muscle pain, fatigue and sleep disorders. The cause is unknown. Prescrire's review focuses on differential diagnoses and available treatments for fibromyalgia, based on a review of the literature.
Full review (5p) in English available for download by subscribers.

Cancer drugs: often insufficiently evaluated

Evaluation of a drug’s effectiveness must be based on rigorous and reliable data relating to clinical outcome that are tangible for patients. In the field of oncology, there is much room for improvement.

Pregnant women: detect and treat bacteriuria

In pregnant women, it is better to detect and treat the presence of bacteria in the urine, even if there are no clinical symptoms.

Pharmacovigilance: the European Commission loses sight of the public interest

A mission of vital public interest is farmed out to pharmaceutical companies, while misplaced priorities and conflicts of interest threaten to slow down decision-making in matters affecting public health.

Childhood obesity:
outweighed by economic interests

The French government has agreed a "code of conduct" with the media and food industries – a smokescreen to dissuade politicians from curbing advertising for sweets and high-fat foods aimed at children.

Breast-feeding: very few contra-indications

Situations where infant formula is preferable to breast-feeding are rare.

Pharmaceutical marketing:
congratulations to the doctors who resist!

Pharmaceutical companies classify doctors according to their relations with their sales reps. An attitude that is far removed from patients’ interests.

Do industrial interests take priority over
human health?

Specific interests have a considerable influence over health decisions. Economic interests can delay public health decisions, as seen in the past with asbestos, lead, silica, the REACH chemical safety regulations and benzene.

Seveso: an industrial accident that raised awareness

There is a real consciousness of the need to manage industrial risks. But the practical decisions taken are not always sufficient. The Seveso disaster was the wake-up call that made European countries aware of the need to improve the management and control of industrial risks. It led to the adoption of two EU directives known as the Seveso directives.

Waste disposal and environmental health risks:
a complex situation

Our environment is sensitive, and affects our health in numerous ways. Understanding environmental health issues helps us to improve protection.

Gefitinib in non-small cell lung cancer:
still very disappointing

FEATURED REVIEW In patients with non-small cell lung cancer, there is no firm evidence that gefitinib is effective as a first-line treatment. Similarly, it has not been demonstrated that gefitinib is as effective as docetaxel in second-line treatment. Gefitinib has severe adverse effects, including interstitial pneumonia.
Full review (3p) in English available for download by subscribers.

Panitumumab in metastatic colorectal cancer:
don’t make things worse!

FREE DOWNLOADAdding panitumumab to symptomatic treatment in patients with metastatic colorectal cancer who failed to respond to the two most widely used protocols scarcely increases survival or progression-free survival. Like other monoclonal anti-EGFR antibodies, panitumumab provokes sometimes serious adverse effects in most patients: epithelial toxicity (skin) and hypersensitivity reactions.
Full text available for free download.

Breast-feeding until 6 months should be encouraged in most cases

Breast milk is generally better for the child’s health than infant formula. Breast-feeding alone is sufficient for most infants until the age of 6 months.

Fever in children: paracetamol is the best treatment to relieve the symptoms

When medication is required to reduce fever in children, paracetamol alone is the best choice.

Asbestos: medical monitoring but
no routine screening

In France, screening for asbestos exposure can lead to financial compensation. But it has no proven effectiveness in improving patients' life expectancy or quality of life.

Controlling glucose levels in type 2 diabetes:
aim for an HbA1c level of around 7%

Controlling hyperglycaemia by keeping the HbA1c level at around 7% can result in a lower mortality rate.

Counselling encourages women to choose and persevere with breast-feeding

Giving women some simple, appropriate tips encourages them to choose breast-feeding from birth and to persevere with it.

Docosanol: barely more effective than an excipient against herpes labialis

FEATURED REVIEWDocosanol, a fatty alcohol, was recently authorised in France for treatment of episodes of herpes labialis. It is barely or no more effective than an excipient in treating acute episodes. Lifestyle measures are still the cornerstone of herpes management.
Full review (2p) in English available for download by subscribers.

Drug packaging in 2008: progress needed

Proper packaging, a key factor in the correct use of medications, is all too often neglected by pharmaceutical companies and drug regulatory agencies alike. But a few companies do prove that it is possible to do a good job.

Intra-uterine devices: highly effective contraception

In many cases, intra-uterine devices (IUDs) are an effective alternative to oral contraceptives.

Sildenafil in Europe: on medical prescription only

Erectile dysfunction requires investigation of the possible organic or psychological causes. Sildenafil causes sometimes severe adverse effects, particularly cardiovascular. Two good reasons to restrict its use and to maintain it as a prescription-only drug.

Pharmaceutical companies’ marketing budgets: bigger than estimated

The already hefty official figures for the pharmaceutical industry’s marketing expenditures are certainly underestimated. The end cost is borne by patients and by the health insurance system.

Programme for improving professional practice: Prescrire’s experience

"Avoid nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy" was the stated aim of the highest number of Prescrire subscribers.

Orlistat (Alli°) available without a prescription:
non-negligible risks for modest weight loss

When a person needs to lose weight, it is better to concentrate on non-drug methods.

Health authorities: hamstrung by their dependency on pharmaceutical companies?

Health authorities sometimes seem incapable of exerting their will, so dependent are they upon pharmaceutical companies.

Dextropropoxyphene-paracetamol combination (Di-Antalvic° and other brands): withdrawn from pharmacies in France

NEWS UPDATEOn 25 June 2009, the European Medicines Agency (EMEA) finally decided to "recommend" the withdrawal from the market of the dextropropoxyphene-paracetamol combination (Di-Antalvic° and other brands). The French Health Products Safety Agency (AFSSAPS) waited for this "recommendation" before deciding to withdraw the combination, unlike drug agencies in other European countries who had already effected the withdrawal, sometimes several years earlier.

Dabigatran in thromboembolism prophylaxis:
heparin is a better-known option

FEATURED REVIEWDabigatran, a specific thrombin inhibitor, was recently licensed for preventing thromboembolic events after hip or knee replacement surgery. It is better to continue to use heparins, at least pending more thorough evaluation of dabigatran.
Full review (5p) in English available for download by subscribers.

Prescrire's finances: total transparency

Financed solely through subscriptions, Prescrire publishes its accounts each year. Prescrire is one of the world’s few continuing education organisations for healthcare professionals that is completely independent both of the pharmaceutical industry and the health authorities.

In the June issue of Prescrire International:
adverse effects of sitagliptin, corticosteroids and mydriatic eye drops

FREE DOWNLOADMydratic eyedrops can cause severe adverse effects in children and the elderly. Corticosteroids, whether they are inhaled, injected or taken orally, have neuropsychiatric adverse effects. And the EMEA, at the express request of Prescrire, released a review of the allergic adverse effects of the blood glucose-lowering agent sitagliptin.
This sample page is available for free download.

Drug counterfeiting: false and genuine problems

Drug counterfeiting mainly affects poorly controlled pharmaceutical channels such as those in poor countries and on the internet. Some solutions currently being offered to combat counterfeiting are designed to strengthen the major pharmaceutical companies’ control over the markets in the face of the growing power of firms in the emerging economies.
Full text is available for download by subscribers.

Pregnancy: no nonsteroidal
anti-inflammatory drugs

Nonsteroidal anti-inflammatory drugs in any form should be avoided throughout pregnancy.

Health professionals and patients: the best alliance

The alliance of health professionals and health service users is the most promising approach to improve the quality of care and uphold patient choice.

Trimetazidine: unfavourable risk-benefit balance increasingly confirmed

Trimetazidine is still on the market as a treatment for various disorders, even though its efficacy is unproven and it can cause sometimes severe adverse neurological effects.

Irritable bowel syndrome: a mild disorder,
purely symptomatic treatment

FEATURED REVIEW The only available treatments have purely symptomatic effects and only limited efficacy. Patients with no other signs of a condition warranting specific treatment should be reassured as to the harmless nature of their disorder if a careful physical examination and basic laboratory tests are negative.
Full review (5p) in English available for download by subscribers.

Drugs: going back to essentials

It is increasingly rare that new drugs offer patients tangible improvements. But older, tried-and-tested essential drugs with a favourable risk-benefit balance continue to fulfil a wide range of needs. {{The Prescrire Drug Awards and a look back at 2008 are available online.}}

Household aerosols: risk of asthma symptoms

The use of household aerosols seems to be linked to asthma symptoms, even in the absence of pre-existing asthma.

Clinical practice guidelines from the French National Authority for Health need improving

Many of the clinical practice guidelines published by France's National Authority for Health leave much to be desired.

Hand-washing proves effective for preventing diarrhoea in children

Everywhere in the world, washing the hands is effective in reducing the frequency of diarrhoea in children.

Vitamin B and folic acid supplements do not prevent cardiovascular diseases

Despite the attractiveness of the hypothesis, folic acid and vitamin B6 and B12 supplements do not lead to a reduction in cardiovascular diseases.

Drug developments in 2008: a serious lack of quality

2008 was a poor year for drug developments. The results are worrying. Prescrire's annual review of new drugs and new indications turns up few positive assessments and a record number of "not acceptable" ratings.
Full texts in English available free online.

Drug-eluting coronary stents:
many meta-analyses, little benefit

FEATURED REVIEW Drug-eluting stents have been developed with the objective of reducing the risk of recurrent stenosis. We examined the available literature, based on the standard Prescrire methodology. Drug-eluting stents appear to be no more effective than bare metal stents in reducing overall mortality, cardiac mortality, the risk of myocardial infarction, or stent thrombosis.
Full review (5p) in English available for download by subscribers.

Too many new drugs with a disproportionate risk-benefit balance

In granting marketing authorisations to new drugs with an extremely unfavourable risk-benefit balance, drug regulatory agencies are not serving the interests of the population.

Self-medication: putting drugs back in their rightful place

Self-medication does not give more power to patients, but to the companies who market the drugs. A discussion-debate on the subject was held at Prescrire's annual "Pilule d'Or" ceremony.
Details of the discussion-debate available free online.

In the April issue of Prescrire International:
duloxetine in generalised anxiety too?

FREE DOWNLOADDuloxetine (Cymbalta°) in generalised anxiety? No thanks! There is no tangible efficacy but numerous and sometimes severe adverse effects.
Full text available for free download.

Obesity: diet, physical exercise and support
are the priorities

The treatment of overweightness and obesity involves a balanced, moderately low-calorie diet, regular, moderate exercise, and individual support.

Implantable port catheters for
intravenous infusion

Patients given an implantable port catheter for intravenous infusion should understand how it works and be taught how to operate it, above all to avoid complications.

The common cold

FEATURED REVIEW Since July 2008 some products can be sold over the counter in France for the self-medication of about 20 common medical conditions. Prescrire has decided to provide key information to healthcare professionals and the public in order to help them cope with these conditions. This review deals with the common cold.
Full review (2p) in English available for download by subscribers.

Pregnancy: avoid some antihypertensives

Some antihypertensives (ACE inhibitors and angiotensin-II receptor antagonists) expose unborn babies to the risk of severe malformation. There are numerous other antihypertensives which should be prescribed instead.

Swiss initiative:
a more active role for pharmacists

The involvement of pharmacists in good drug use in Swiss institutions for the elderly shows that spending on medicines can be reduced without diminishing the quality of care.

Combating medical disinformation:
the Reunion Island experiment

Healthcare professionals in the French overseas territory of Reunion Island have joined forces to provide the general public with reliable, independent medical information.

In the February issue of Prescrire International:
Rivastigmine patches

FREE DOWNLOADRivastigmine patches are marketed for symptomatic treatment of "mild to moderately severe Alzheimer’s dementia". However, the patches provide no practical advantages over rivastigmine capsules. It is therefore better to avoid using them.
Full text available for free download.

Fungal nail infections:
diagnosis and management

FEATURED REVIEW Fungal nail infection, or onychomycosis, mainly affects toenails. Discomfort and cosmetic complaint are occasionally reported. After a review of the literature based on the standard Prescrire procedure, we examined its diagnosis and management.
Full review (4p) in English available for download by subscribers.

Pharmaceutical quality: also an issue in Europe

In Switzerland, a production flaw resulted in the contamination of a drug by a potentially carcinogenic substance.

Duloxetine: to be avoided in all circumstances

Despite its many potentially severe adverse effects and its modest or rather dubious efficacy, duloxetine is marketed for a range of indications.

Improved care practice: the example of Tournus

The experience of a French hospital identifies success factors and obstacles to be overcome in the development and updating of reliable aids to therapeutic decision-making: a real collective, sustained means of improving professional practice.

Continuing education:
he who pays the piper calls the tune

Pharmaceutical companies make no secret of the fact that they invest in continuing education for health professionals so as to influence their practice. It is up to health professionals to refuse such compromises.

Drug evaluation: an ongoing process

Evaluating a drug does not simply involve applying for a marketing authorisation: confirmation of data at a later stage is needed.

Preventing mosquito-borne infections

FEATURED REVIEW Malaria is a major public health problem in 90 countries. Effective protection against mosquito bites is particularly important where there is a high risk of potentially severe infections. Prescrire conducted a review of the evidence to determine how to prevent mosquito bites both effectively and safely.
Full review (4p) in English available for download by subscribers.

Menopause: hormone replacement therapy
and breast cancer

Following a decline in hormone replacement therapy (HRT), a drop in the number of cases of breast cancer has been observed, particularly in France.

The cold: wrap up warmly

Cold weather causes excessive mortality of cardiovascular or pulmonary origin. The winter cold causes frostbite, which can be serious, and hypothermia. The most vulnerable should be protected. Special precautions should be taken when administering first aid.

Outstanding Prescrire readers:
congratulations to the class of 2009

Thousands of health professionals demonstrate their ongoing commitment to self-financing reliable training.

Health spending: a matter of choice

Winter cold: the cost of reducing some effects of social exclusion is modest, especially compared with some health spending whose benefits are sometimes extremely limited.

Intermittent claudication: smoking cessation, regular physical exercise and an antiplatelet drug

Smoking cessation and physical exercise, especially walking, and taking antiplatelet drugs are the priority measures for intermittent claudication.

In the December issue of Prescrire International:
Progestagen-only treatment before menopause

FREE DOWNLOAD There is widespread use of progestagen-only products before menopause, in spite of the lack of robust evidence concerning their risk-benefit balance. A recent French study showed an increase in breast cancer among women using an oral progestagen. It is advisable to evaluate drugs before their use provokes adverse reactions in patients.
Full text available for free download.

Dental amalgam: Few proven harmful effects
but many ongoing concerns

FEATURED REVIEW Dental amalgam is one of the main sources of exposure to mercury in industrialised countries. Evaluation of risk-benefit balances of alternatives to dental amalgam does not provide sufficient data to base an informed choice between available options.
Full review (5p) in English available for download by subscribers.

Smoking cessation: no to varenicline

When a smoking cessation drug seems advisable, nicotine is the drug with the best risk-benefit balance.

Pregnancy: beware of drugs,
even self-medication products

Many pregnant women self-medicate, but few are aware of the dangers some ordinary drugs can pose to the unborn baby.

Type 2 diabetes: pioglitazone still on the market despite its unfavourable risk-benefit balance

Although it offers no benefits to diabetic patients and can have sometimes severe adverse effects, pioglitazone is still on the market, and at a high price.

Newborns in intensive care:
too many painful procedures

In the care of newborns, pain and discomfort caused by some nursing procedures could be better prevented.

Sore throat: sucking sweets is sufficient

To relieve sore throats, no topical drug offers any tangible benefit over a sweet.

Ziconotide: limited analgesic efficacy,
too many adverse effects

FEATURED REVIEW Ziconotide is not an opiate and is not related to the usual classes of analgesic drugs. The efficacy of ziconotide in relieving neurogenic pain remains to be established. In cancer pain, the available evidence showing that ziconotide is effective after opiate failure is too weak in view of the potential risks.
Full review (4p) in English available for download by subscribers.

Cleaning wounds with tap water:
possible under certain conditions

In countries where the water is subject to strict bacteriological controls, wounds may be cleaned with tap water.

Self medication: putting drugs in their place

In some common situations, drugs are unnecessary. Prescrire’s information sheets outline these situations to help determine when it is necessary to seek the advice of a professional, which drugs should be avoided and which ones may be helpful.

Pergolide: an antiparkinson treatment
with cardiac risks

Pergolide offers no benefits and exposes to numerous risks, especially cardiac.

Benfluorex: still on the market, despite numerous severe adverse effects

New evidence confirms that benfluorex can cause severe adverse effects. Its unfavourable risk-benefit balance justifies its withdrawal from the market.

Duloxetine: to be avoided in all cases

Despite its unfavourable risk-benefit balance, duloxetine is marketed for a range of indications.

Vaccine advertising: no to abridged patient information

It is deplorable that vaccine advertising via the powerful media of TV and radio is allowed to contain abridged health information.

Dexfenfluramine:
law suits in France and elsewhere

Complaints by patients who have suffered adverse effects are investigated case by case in France, unlike in other countries where victims can bring class actions.

In the October issue of Prescrire International:
No glitazones for diabetic patients!

FREE DOWNLOAD There are still no data conclusively demonstrating that glitazones prevent clinical complications of diabetes. An increased risk of adverse effects has been confirmed in patients treated with pioglitazone. There is no justification for adding a glitazone to insulin in the treatment of type 2 diabetes.
Full text available for free download.

Sleep complaints: whenever possible,
avoid the use of sleeping pills

FEATURED REVIEW How can patients who complain of poor-quality sleep be helped, without resorting to treatments that can have adverse effects? Misconceptions and worrying over the lack of sleep and its consequences can contribute to reinforcing these disorders. We conducted a systematic review of the literature based on the standard Prescrire procedure.
Full review (7p) in English available for download by subscribers.

Osteoporosis: bisphosphonates can cause muscular, bone and joint pain

Bisphosphonates can cause incapacitating musculoskeletal pain.

Clinical practice guidelines:
useful when they are of high quality

Prescrire assesses the quality and consistency of the guidelines published by France’s main health authority, the Haute autorité de santé (HAS), applying an explicit marking system based on internationally recognised assessment criteria.

Nonsteroidal anti-inflammatories should be avoided during pregnancy, even topical gels

Any form of nonsteroidal anti-inflammatories (NSAIDs) taken in pregnancy expose the foetus to the risk of potentially severe disorders.

Diabetes: exenatide,
a worrying glucose lowering agent

Further to a request by Prescrire, the European Medicines Agency has published a list of sometimes severe adverse effects caused by exenatide. The benefits of this drug seem to be increasingly slender.

Drugs: don’t sidestep pre-approval evaluations

Marketing approval exemption procedures are fast-tracking some drugs to market, to the detriment of the evaluation quality.

Pharmacists are not obliged to sell drugs over-the-counter

Prescrire suggests that pharmacists who do want to make drugs available over the counter draw up a strict list.

Evaluation of new drugs:
no to "non-inferiority" trials

Drugs offering no proven therapeutic benefits are being approved thanks to so-called "non-inferiority" clinical trials.

Fentanyl by iontophoresis

FEATURED REVIEW A transdermal system for fentanyl, an opiate analgesic, will soon be marketed in France for patient-controlled relief of acute postoperative pain by iontophoresis, a needle-free technique. This system not particularly convenient and there is a risk of misuse and overdose.
Full review (4p) in English available for download by subscribers.

In the August issue of Prescrire International:
No to daily tadalafil (Cialis°)

FREE DOWNLOAD Tadalafil (Cialis°, Lilly) was first marketed in France in 2003. In 2007, Lilly added two lower dose strengths and promoted them for once-daily use. The lack of long-term safety data on daily use of tadalafil calls for caution. It is better to continue using tadalafil "on demand".
Full text available for free download.

Artemisinin derivatives and malaria

FEATURED REVIEW Plasmodium falciparum malaria can be fatal, especially in young children and non-immune persons. Several drugs are effective but emergence of parasite resistance limits the choice. We conducted a review of the literature, based on Prescrire’s standard methodology.
Full review (7p) in English available for download by subscribers.

Diabetes and alcohol: some useful pointers

FEATURED REVIEW Many diabetic patients, like the rest of the population, enjoy alcoholic drinks. We conducted a review of the literature for information on the possible risks of alcohol consumption for diabetic patients, based on Prescrire's standard in-house methodology. Drinking one standard unit a day seems to be an acceptable amount.
Full review (3p) in English available for download by subscribers.

Toxic chemicals:
little prevention or follow-up in France

In 2005 in France, around 2.5 million workers are reported to have been exposed to some 5 million tonnes of toxic chemical agents, with inadequate preventive measures or information.

Medicinal plants: frequent use in France

Plant-based products, often mistakenly considered as harmless alternative remedies, are sometimes the cause of severe adverse effects and can interfere with a number of drugs. Health professionals must be informed of the use of these products before prescribing or giving other medicinal treatments.

Listen to patients for a better understanding of drugs' adverse effects

Reporting of adverse effects by patients helps build an improved understanding of drugs.

Clinical trials should be registered to prevent data manipulation

Defining the protocols for clinical trials in publicly accessible registers prior to commencement of the trials would help identify drugs’ real risk-benefit balance.

Cramps: no to Okimus°

This quinine-based drug used to treat nocturnal leg cramps has a distinctly unfavourable risk-benefit balance. Its packaging and presentation are unsafe, making it look like a sweet, which poses a real danger to children.

In the June issue of Prescrire International:
Papillomavirus vaccine types 16 and 18

FREE DOWNLOAD The papillomavirus 16, 18 vaccine, like the papillomavirus 6, 11, 16, 18 vaccine, reduces the risk of high-grade cervical dysplasia due to all viral genotypes by about 40% in young women who are not yet infected at the time of vaccination. The vaccine does not seem to provoke any serious adverse effects, but there is no proof that it reduces the risk of cancer.
Full text available for free download.

Arterial hypertension: second-line treatment

FEATURED REVIEW Reliable evidence supports the use of thiazide diuretics as first-line treatment for uncomplicated arterial hypertension. When patients fail to reach blood pressure targets, or this treatment is poorly tolerated, what are the best second-line options? We reviewed the available evidence, based on our standard in-house methodology.
Full review (4p) in English available for download by subscribers.

Slight memory loss: cholinesterase inhibitors offer no proven benefit

In people over 50 presenting moderate memory loss, cholinesterase inhibitors, marketed as a treatment for Alzheimer’s disease, offer no proven benefit in preventing dementia, and cause numerous adverse effects.

Antioxydants: no proven preventive effect, and some even increase mortality

In the absence of an obvious deficiency, antioxydants (vitamin E, carotene, etc.) have no proven health benefits, and some are probably harmful.

SSRI antidepressants cause aggression

Treatment of depressive patients should start with non-drug measures. Antidepressants should be reserved for incapacitating disorders that are resistant to these measures, and patients should be closely monitored.

Depression in children:
drugs should not be a first-line treatment

Treatment of children and adolescents considered to be depressive should rely first and foremost on non-drug treatments. Currently there is no antidepressant that has a favourable risk-benefit balance in children.

Knowing a disease’s natural history helps make decisions

It is vital to be aware of a disease’s natural outcome in order to make pertinent treatment decisions, in particular to define the aim of treatment.

Aliskiren : no evidence of clinical efficacy

FEATURED REVIEW Aliskiren is the first renin inhibitor to reach the market for management of arterial hypertension. The adverse effect profile does not seem to be any better than that of other antihypertensive drugs, and better-assessed drugs with longer followup are available.
Full review (4p) in English available for download by subscribers.

No to pharmaceutical firms'
"compliance support" programmes

In spring 2007, following massive protests, the French Health Minister was forced to withdraw draft legislation allowing the pharmaceutical firms' "compliance support" programmes. The proposed law permitted staff on the firms' payroll to ensure that patients were following their treatment for chronic conditions.

Trimetazidine:
witholding information from patients

Trimetazidine has an unfavourable risk-benefit balance. Contrary to the information provided to health professionals, the patient information leaflet does not inform patients of the need to review the prescription after three months' treatment.

"Freely available" drugs: not compulsory

Some drugs are described as "freely available" to patients in pharmacies. But where will patients find reliable information enable them to make informed choices?

Self-medication: brand name mix-ups

Brand name extensions known as "umbrella" brands, created to bring several drugs under one name, reduce drugs to a mass-market product and patients to consumers who are unaware of what they are taking.

Osteoporosis and the prevention of fractures: bisphosphonates offer little benefit after 5 years

Bisphosphonate treatment for postmenopausal women with severe osteoporosis provides limited efficacy for the first 5 years, but can cause sometimes severe adverse effects. Beyond this period, the benefit is minimal given the adverse effects.

In the April issue of Prescrire International:
Budesonide + formoterol, a step backwards

FREE DOWNLOAD The budesonide + formoterol combination should not be recommended for "on demand" use to control asthma attacks. It exposes patients to an added risk of adverse effects, and undermines the clear distinction between maintenance treatment and control of attacks that has been found to help patients manage their asthma.
Full text available for free download.

Osteodensitometry in healthy
postmenopausal women

FEATURED REVIEW Osteodensitometry is the standard method for measuring bone mineral density. To determine whether measurement of bone mineral density is useful in the prevention of fractures in postmenopausal women, we reviewed the relevant literature using our established in-house methodology.
Full review (4p) in English available for download by subscribers.

Medical guidelines: pros and cons

Medical guidelines are a good thing if doctors are failing to provide optimum patient care. But they should not be allowed to hinder doctors seeking to identify the best care for each individual patient.

Helping smokers quit: avoid varenicline

More and more cases of gastrointestinal, neuropsychiatric and cardiovascular adverse effects linked to varenicline are being reported.

Cox-2 inhibitors: half measures

Although Cox-2 inhibitors present no demonstrable therapeutic advantages, they have been shown to cause serious adverse effects. Drug regulatory agencies have settled for half-measures that favour the interests of the pharmaceuticals industry.

Paediatrics: beware of unsuitable drugs and cosmetics

Some cosmetics and drugs used to treat benign disorders in children can expose them to potentially severe adverse effects.

Colchicine: interactions and severe, sometimes fatal adverse effects

The use of colchicine is controversial due to its severe, sometimes fatal adverse effects. It is best only to prescribe it for gout attacks if analgesics and antiinflammatory treatments prove ineffective.

Acne: danger of lesions of the mucous membranes with isotretinoin

In addition to the risk of teratogenic effects, oral isotretinoin can cause adverse effects to the mucous membranes, especially in the stomach.

Obesity: sibutramine linked to cardiac disorder

New evidence confirms that sibutramine has an unfavourable risk-benefit balance, with sometimes severe, even fatal, adverse effects.

Oral mucositis due to cancer treatments:
oral hygiene and ice cubes

FEATURED REVIEW Oral mucositis is a frequent adverse effect of cancer chemotherapy and radiotherapy, and can keep patients from drinking and eating normally. Prevention is based on orodental care and ice. Other treatments are no more effective and carry a risk of known or poorly documented adverse effects.
Full review (3p) in English available for download by subscribers.

Giving up smoking: varenicline linked to depression and suicidal thoughts

For smokers wishing to quit, if medical treatment is necessary, nicotine is the best option as it has a more favourable risk-benefit balance.

Taste disorders may be drug related

Numerous drugs can cause taste disorders, which can lead to anorexia and a deterioration in a patient’s general condition.

Compulsive behaviour can be drug related

Some drugs, particularly those used to treat Parkinson’s disease, cause pathological behaviour such as gambling or hypersexuality, which can affect a person’s family and social life and even have legal consequences.

Passive smoking: avoidable harm

It is now a fact that passive smoking is damaging.

Self-medication: speak the truth

Self-medication using drugs hyped by advertising but whose efficacy is limited is not beneficial to patients.

Alzheimer’s drugs: officially disappointing

The French National Authority for Health (Haute autorité de santé – HAS) has finally acknowledged that drugs used to treat Alzheimer’s disease do not deter its progression. Human and social care is crucial for patients suffering from this disease.

Prescrire's finances: total transparency

Prescrire, funded solely by subscriptions, publishes its accounts annually.

Olanzapine: one lawsuit after another in the USA

More than 28,000 people received compensation from Lilly for dropping suits relating to olanzapine.

In the February issue of Prescrire International:
Haemorrhage due to Ginkgo biloba?

FREE DOWNLOAD About 20 detailed reports of haemorrhage in patients using Ginkgo biloba extracts have been published. In practice, patients with risk factors for bleeding (anticoagulant or antiplatelet treatment,surgery, etc.) should avoid using Ginkgo biloba extracts.
Full text available for free download.

Mammographic screening for breast cancer

FEATURED REVIEW A new comparative randomised trial of mammographic screening for breast cancer showed no significant reduction in breast cancer mortality. After 7 screening mammograms, 23% of the women had at least one false-positive result. Healthcare professionals need to inform their patients of the many uncertainties concerning mammographic screening.
Full review (4p) in English available for download by subscribers.

Rare diseases: more new drugs, mixed results

Patients suffering from rare diseases are entitled to drugs that have been adequately evaluated, and that can give them concrete guarantees, not just hope.

Chemotherapy interferes with enjoyment of food

For many cancer patients undergoing chemotherapy, eating becomes an unpleasant, even fearful, experience.

Microwaveable gel packs can cause severe burns

The use of certain warming devices can be dangerous, especially for infants, the elderly or diabetic patients.

Sleep disorders: avoid medication if possible

Non-drug therapies should be offered as a first-line treatment for complaints of insomnia.

Transparency in the pharmaceutical industry: Prescrire's 2007 Information Awards

Prescrire rewards the companies that act responsibly by making their full data available to Prescrire editorial staff. And Prescrire reminds companies who fail to do so that releasing this information is in patients' best interests.

Prescrire's 2007 Packaging Awards:
good news and bad news

Good packaging is essential for a drug's correct use.

Prescrire's 2007 Drug Awards:
progress for patients

Prescrire's annual awards acknowledge drugs that demonstrate tangible improvements for patients.

Drug packaging in 2007:
better, but still many risks

All too often, pharmaceutical companies and drug regulatory agencies pay little attention to drug packaging. But some companies have shown that it is possible to do better.

Prescrire's annual medicines review:
health authorities are too lax

Pharmaceutical companies are not subjected to adequate controls.

Etoricoxib

FEATURED REVIEW Cox-2 inhibitors are no more effective than traditional NSAIDs and have no tangible advantages in terms of gastrointestinal tolerability. In contrast, they expose patients to an increased risk of cardiovascular adverse effects.
Full review (5p) in English available for download by subscribers.

Hepatitis B: continue vaccinating

In France, hepatitis B is a frequent viral infection with sometimes severe consequences. With vaccination, more than 90% of these infections are preventable. The risk-benefit balance is favourable.

Trouble falling asleep: no drugs for children

Treating sleeping disorders in children should rely on non-drug therapies, primarily on promoting healthy sleep habits.

2007: the therapeutic year in review

Prescrire's annual drug review is the opportunity for caregivers to update their latest treatment options, based on impartial information.

Evaluating a treatment: focus on clinical criteria reflecting patients' priorities

A treatment's efficacy must be measured according to pertinent clinical criteria, keeping in mind any adverse effects.

Stock market and society: conflicting values

Since they are both vital components of human health and industrial commodities, drugs are governed by sometimes contradictory principles and values.

Direct-to-public advertising of prescription drugs: harmful and unmanageable

It is contrary to the public interest for pharmaceutical companies to provide consumers directly with "information" on prescription drugs.

Conflicts of interest: not taken seriously enough

It would benefit the public if the interests of certain influential figures in French pharmaceuticals and healthcare were made known.

Self-medication: an undeserved second chance for drugs whose efficacy is questionable

It makes good sense that drugs whose efficacy remains unproven not be reimbursed by the national health insurance system. It makes no sense to promote the purchase of the same drugs by consumers, under the pretence of encouraging "self-medication".

NSAIDS: COX-2 inhibitors should be withdrawn

Celecoxib should be taken off the market, given its negative benefit-harm balance.

In the December issue of Prescrire International:
Risk of burns with some transdermal patches

FREE DOWNLOAD The waterproof outer layer protecting some transdermal patches is composed of aluminium. This creates a risk of burns, especially when the patient is exposed to electric shocks or intense magnetic fields. If in doubt it is best to temporarily remove all transdermal patches before MRI or external defibrillation.
Full text available for free download.

Multiple sclerosis: interferon beta for some serious forms

FEATURED REVIEW Multiple sclerosis is a neurological disorder with highly variable clinical repercussionsn ranging from minor deficits to severe disability and even death. This review article, based on Prescrire’s standard in-house methodology, examines treatments proposed to slow the progression of multiple sclerosis.
Full review (6p) in English available for download by subscribers.

Less salt, less risk of cardiovascular events

Reducing salt intake reduces the long-term risk of cardiovascular events.

Nimesulide: a nonsteroidal anti-inflammatory with serious hepatic reactions

Nimesulide exposes patients to fatal liver damage. When a non-steroidal anti-inflammatory is necessary, it is better to use one with a favourable benefit-harm balance, such as ibuprofen.

Post-market follow-up studies:
lack of transparency

It is essential to follow up on drugs after their release onto the market. However, very few results are ever published.

Drug information from regulatory bodies and health authorities: too confusing and incomplete

The summaries of product characteristics (SPC) produced by drug regulatory bodies are inadequate.

To avoid medication errors,
use the INN - a drug's real name

Brand names for drugs are not compulsory: they are nothing but marketing. Using the International Nonproprietary Name (INN) in patient care helps reduce the risk of medication error.

Long-term asthma therapy:
adapt steroid therapy to severity

FEATURED REVIEW Asthma's natural history varies over time. Clinically, it ranges from fleeting respiratory discomfort to incapacitating dyspnoea due to frequent and severe attacks. This article examines the general principles of long-term drug therapy for asthma patients, taking into account the results of clinical drug evaluation.
Full review (6p) in English available for download by subscribers.

Preventing foot problems in the elderly to maintain autonomy

Simple hygiene and foot care measures can help the elderly to maintain their independence.

Gout attack: ice and paracetamol, then a nonsteroidal anti-inflammatory drug

The first-line treatment for a gout attack is paracetamol and the application of ice. If this fails, it is best to resort to a nonsteroidal anti-inflammatory drug such as ibuprofen.

Adverse drug effects:
poor follow-up in hospital too

All too often, adverse effects are ignored in hospitals.

Zolpidem: risk of dependence

Like the classic benzodiazepines, zolpidem can also lead to dependence and withdrawal syndrome.

New Alzheimer drugs: serious, sometimes
fatal adverse effects

Drugs used to treat Alzheimer’s disease have serious adverse effects and only limited effectiveness.

Cisapride should be withdrawn from the market

Indicated for gastro-oesophageal reflux in young children, cisapride has serious adverse effects. French health authorities are being irresponsible in not completely withdrawing this drug from the market.

Adverse effects: children too

Studying the effects of drugs on children is a welcome move towards improved paediatric care. But that does not mean we should resort to drugs for every childhood illness.

Healthcare for illegal immigrants:
money well spent

A report from top-ranking French officials calls for increased state medical aid for illegal immigrants, citing both health and financial reasons.

Compliance support programmes:
don't confuse the issues

Pharmaceutical companies wrongly claim that their “compliance support” programmes are mandatory.

Drug regulatory bodies:
experts under the influence

Disclosure of their experts' links to pharmaceutical companies does not ensure that drug regulatory agencies' decisions are impartial.

Female sexual dissatisfaction

FEATURED REVIEW The causes of sexual dissatisfaction are as complex as sexuality itself. Many factors can have an influence, and there are no norms. We conducted a review of the literature based on standard Prescrire methodology, to see whether hormone therapy is appropriate for postmenopausal women seeking help with sexual dissatisfaction.
Full review (4p) in English available for download by subscribers.

In the October issue of Prescrire International:
Rituximab in lymphoma maintenance therapy

FREE DOWNLOADFavourable short-term results need longer-term confirmation in terms of effects on survival. They also need to be weighed against the risk of serious adverse effects: infections, cardiac and gastrointestinal disorders.
Full text available for free download.

Mammography and breast cancer screening: enabling women to make informed choices

Mammography screening for breast cancer does not offer any proven benefit for the general population under the age of 50, barring any particular risk. Between the ages of 50 and 69, the effectiveness of current screening is limited. Over the age of 70, there is not sufficient available evidence in support of screening.

Bisphosphonates and osteonecrosis of the jaw: insufficient risk warning

In autumn 2007, in France, the risk of osteonecrosis of the jaw (bone damage) is not always mentioned in regulatory information on bisphosphonates.

Hypnotic drugs and the elderly: to be avoided

It is better to avoid using hypnotic drugs for elderly people given the many adverse effects and difficulty in discontinuing treatment.

Quitting smoking:
varenicline causes myocardial infarction

When a drug treatment seems advisable to help a paient quit smoking, nicotine remains the drug of reference.

Parkinson's disease:
stick with conventional treatments

At the onset of Parkinson’s disease, dopaminergic agonists, in particular bromocriptine, remain the reference treatment.

Hay fever: no miracle cure

Hay fever treatments provide limited benefits and can cause major adverse effects. Subcutaneous desensitisation is inconvenient and not very effective. Sublingual desensitisation is no improvement.

Compliance: no simple matter

Patients sometimes have good reasons for interrupting their treatment, especially when it presents a negative benefit-harm balance.

Dextropropoxyphene: still on the French market, despite the risks

The combination of dextropropoxyphene + paracetamol was France's second most prescribed reimbursable drug in 2006. It has been withdrawn from the market in several European countries due to its serious adverse effects.

Drugs: don't be fooled by gimmicks

Pharmaceutical firms are reduced to promoting gimmicky drug formats that offer no additional patient benefits.

Obesity: weight loss without drugs

FEATURED REVIEW To determine which interventions have the greatest and most durable impact on weight, without a risk of serious adverse effects, we conducted a systematic review of the available evidence, based on standardised Prescrire methodology. A variety of non drug measures can help, but they only lead to modest enduring weight loss.
Full review (6p) in English available for download by subscribers.

World Health Organization:
inappropriate methods

The credibility of an organisation depends on the reliability of its working procedures, which must be transparent

Diethylsilbestrol (DES): damage after 30 years

DES, a drug at the centre of a very serious mass medical error, should be held up as an example to prevent similar medical errors continuing for so many years.

Schizophrenia: no to placebo-controlled
clinical trials!

In a serious illness such as schizophrenia, for which there are effective drugs, conducting placebo-controlled clinical trials is not ethically acceptable.

Anti-inflammatory drugs to be avoided

In treating pain, when a nonsteroidal anti-inflammatory drug is deemed useful, it is better to use ibuprofen and avoid anti-inflammatory drugs such as cox-2 inhibitors.

Eczema: no tacrolimus

Immunosuppressants in ointment form present a negative benefit-risk balance, and carry a risk of skin cancer in particular. It is better not to use them.

Weight loss: rimonabant causes depression and suicidal symptoms

Even when it is important to lose weight, it is better not to use rimonabant due to its numerous neuropsychiatric adverse effects.

French vaccination schedule: 2007 update

The 2007 French vaccination schedule takes into account the latest evidence on epidemiological evolutions.

Pharmaceutical firms' "compliance support programmes": a comeback

"Compliance support programmes" run directly or indirectly by pharmaceutical firms should not be legalised but quite simply prohibited, in patients’ best interests.

In the August issue of Prescrire International:
Clopidogrel in addition to aspirin

FREE DOWNLOAD In myocardial infarction not treated with angioplasty, the addition of clopidogrel to aspirin seems to benefit some patients. Unfortunately, no evidence is available beyond 4 weeks indicating a better risk-benefit balance for aspirin plus clopidogrel as compared to aspirin alone.
Full text available for free download.

Chronic hepatitis B: a wider range
of therapeutic options

FEATURED REVIEW The treatment options for patients with chronic hepatitis B have improved significantly. This article examines the results of trials of peginterferon and nucleoside/nucleotide analogues (adefovir, entecavir, lamivudine), through a systematic review of the literature based on standardised Prescrire methodology.
Full review (6p) in English available for download by subscribers.

Human papillomavirus vaccine for
genotypes 6, 11, 16 and 18

FEATURED REVIEW The clinical results are promising but further follow-up is needed to answer ongoing questions, including the duration of protection. Cervical cancer screening remains necessary, even for vaccinated women, and a continued need exists for measures designed to prevent all sexually transmitted diseases.
Full review (4p) in English available for download by subscribers.

Obesity: gastric surgery complications

Gastric surgery to treat morbid obesity involves risks and complications that should be discussed in detail with patients.

Nutritional warnings: a sham

Nutritional messages carried by food ads will not have a sufficient impact. More energetic measures are required to combat obesity.

EU directive on medicinal products: progress transposed into French law at last

The progress made thanks to campaigning by civil society needs to be defended in the face of the industry lobby and ambivalence on the part of the government.

In the June issue of Prescrire International:
Atorvastatin + amlodipine: just a commercial ploy

FREE DOWNLOAD The apparent convenience of the fixed-dose combination of atorvastatin + amlodipine might lead prescribers to overlook the fact that other statins and antihypertensive drugs have better risk-benefit balances. Introducing this type of product to the market is a step backwards, not forwards, in overall healthcare quality.
Full text available for free download.

Human papillomavirus: often harmless but in some cases carcinogenic

FEATURED REVIEW Papillomavirus infections are very widespread in the general population worldwide. This article describes the clinical manifestations, prevalence and modes of transmission of human papillomavirus infections, and the role of HPV in human cancer. A systematic literature review was carried out based on methods developed by Prescrire.
Full review (5p) in English available for download by subscribers.

Macular degeneration: photodynamic therapy, even ranibizumab for some patients

In some patients with age-related macular degeneration, the first-choice treatment is verteporfin, despite its modest efficacy. If it fails, ranibizumab is a second resort, as long as there is no risk of stroke.

Pharmaceutical residues in the water

Too many medicines are now being found in surface and ground water.

French drug regulatory agency and health authority: insufficient transparency

The French drug regulatory agency and health authority, slow to enforce transparency obligations, are ducking their responsibilities.

Colds: no to decongestants!

The presence of vasocontrictors in cold remedies is unacceptable, given their sometimes serious, even fatal, adverse effects.

Media: greater transparency concerning health professionals' links with pharmaceutical firms

French health professionals now have an obligation to declare their links with pharmaceutical companies when they speak in public or appear in the media.

Continuing education for health professionals must come from independent sources

The financial stakes being so vast, and yet so often hidden, health professionals must demand that providers of continuing education be independent.

Ivabradine: best avoided in stable angina

FEATURED REVIEW Ivabradine has been approved in Europe for second-line treatment of stable angina. In trials, ivabradine was no more effective than the comparators in preventing angina attacks. For long-term preventive treatment it is better to use better-documented treatments: a betablocker, or, if a betablocker cannot be used, verapamil or amlodipine.
Full review (4p) in English available for download by subscribers.

French practice guidelines for drug treatment of type 2 diabetes: best ignored

In these guidelines, the French drug regulatory agency AFSSAPS and the main health authority, the Haute autorité de santé (HAS), set unacceptable levels and treatment aims and give equal weight to first-line drugs and drugs with an unfavourable benefit-risk balance.

Osteoporosis: oral ulceration caused by bisphosphonates

Bisphosphonates cause painful oral ulcerations when the tablets are sucked or chewed. This adverse effect is avoidable if certain precautions are taken.

Antihypertensive drugs during pregnancy:
no ACE inhibitors and no angiontensin II receptor antagonists

ACE inhibitors and angiotensin II receptor antagonists cause serious adverse effects in the unborn child when administered during pregnancy. It is better to opt for other antihypertensives in women of reproductive age.

Rimonabant: expensive, only partially reimbursed and with an unfavourable benefit-risk balance

Rimonabant should be avoided due to its unfavourable benefit-risk balance in obese patients, whether they are diabetic or not.

"New" diseases: the power of marketing

Labelling people as "sick" does them no favours and needlessly exposes them to potentially serious risks.

Self-medication: a proposal that benefits pharmaceutical companies rather than patients

In France, there are a growing number of initiatives to "open up" the self-medication market. Patients’ real needs are not the main consideration.

Second-line drugs: no to second-rate evaluations

It is not acceptable that second-line treatments should be even more poorly evaluated than first-line drugs.

Methotrexate: avoiding deadly errors

Doctors, pharmacists, pharmaceutical companies and drug regulatory agencies must do everything in their power to put a stop to methotrexate dosage errors.

Flu: reimbursement of Tamiflu° extended to children, despite serious, even fatal risks

Tamiflu° is now reimbursed in France for flu prevention in infants over the age of 1 year, even though its benefit-risk balance is increasingly uncertain.

In the April issue of Prescrire International:
Rivastigmine

FREE DOWNLOAD The adverse effects of rivastigmine outweigh its benefits. It is better to carefully adjust ongoing antiparkinsonian treatments than to add an anticholinesterase. What is the point of exposing patients to a risk of adverse effects and drug-drug interactions when there is little if any chance of a therapeutic benefit?
Full text available for free download.

Arterial "prehypertension": a useful concept for drug companies, useless for patients

FEATURED REVIEW "Prehypertension" is not a useful concept for patient management. The thresholds above which the risk-benefit balance for some treatments becomes positive remain at 160/95 mmHg (140/80 mmHg for patients with diabetes or a history of stroke).
Full review (3p) in English available for download by subscribers.

Cancer therapy: prevention of oral mucositis

The prevention of oral mucositis, a frequent adverse effect caused by some cancer treatments, relies on oral care and, in particular, the sucking of ice cubes before and during chemotherapy sessions.

Dextropropoxyphene: more deaths

Dextropropoxyphene is still being sold in France, even though it has caused deaths and its combination with paracetamol has not been proved any more effective as a painkiller than paracetamol alone.

Severe asthma: omalizumab is not appropriate

The effectiveness of omalizumab is dubious and it can cause serious adverse effects. It is preferable not to use it as a long-term treatment for asthma.

Risk management plans: far from reassuring

Drug risk management plans lack transparency and contain ambiguities.

Clinical practice guidelines: be selective

Prescrire examines clinical practice guidelines, to help readers identify which ones will help them to improve patient care.

Rotavirus vaccines

FEATURED REVIEW Two new oral rotavirus vaccines for immunisation during infancy are being marketed in France. Rotavirus vaccination during infancy is not a public health priority in western countries, but vaccination of individual infants may be useful when access to healthcare is difficult.
Full review (3p) in English available for download by subscribers.

Post-marketing studies: broken promises

Pharmaceutical companies rarely fulfil their promises to conduct trials after a marketing authorisation has been granted. All the more reason to demand full evaluation data before granting approval.

Drug packaging: some progress
but still too much unsafe packaging

A look at well-designed drug packaging shows just how unacceptable poorly designed packaging can be.

Radiotherapy:
serious but preventable adverse effects

Reporting adverse effects suffered by a patient undergoing radiotherapy means that possible errors are remedied faster and won't be repeated on other patients.

Pregnancy: nonsteroidal anti-inflammatory drugs (NSAIDs) must be avoided at all costs

NSAIDs should be avoided in the early stages of pregnancy due to the increased risk of miscarriage or malformation. Paracetamol should be used instead.

Aggressive sexual behaviour: management is difficult and has not been thoroughly evaluated

Managing aggressive sexual behaviour is difficult. While psychotherapy has not been thoroughly evaluated, it seems to be the best option to try first, with patients prepared to cooperate.

Sleep apnoea: some cases should be investigated

Some cases of obstructive sleep apnoea syndrome should be investigated, due to the risk of complications or accidents.

Medical ethics: a U.S. university refuses gifts from pharmaceutical companies

Healthy relations between health professionals and pharmaceutical companies should be taught at university, by example.

Self medication: too much confusion!

The massive outcry over self medication overshadows essential questions, in particular that of weaning the French off of too much medication.

Prescrire is financed entirely by subscribers

Prescrire has been funded solely by its subscribers since 1993. It has been making its accounts public since 1992.

In the February issue of Prescrire International: Pramipexole

FREE DOWNLOAD Restless legs syndrome does not lead to any physical complications. Various treatments have been tried but none has shown any substantial efficacy in the few available comparative trials. It is better to avoid treating patients with restless legs syndrome with pramipexole (or with ropinirole). It’s better to wait until a satisfactory treatment is available.
Full text available for free download.

Alcohol withdrawal syndrome: how to predict, prevent, diagnose and treat it

FEATURED REVIEW When people who are physically dependent on alcohol stop drinking, they experience alcohol withdrawal syndrome. Severe forms may include seizures, hallucinations and delirium tremens, which can be fatal. Patients who are attempting to stop drinking need close personal support, and should be monitored for early signs of withdrawal syndrome.
Full review (8p) in English available for download by subscribers.

Drugs: brand names risk causing confusion

Highlighting the risk of confusion between drugs’ brand names should result in a name change for the brands concerned. This risk underscores the importance of using a drug’s international nonproprietary name (INN) when prescribing.

2006 drug review: advertising
takes precedence over innovation

Pharmaceutical companies are failing to come up with any real innovations, and are spending more and more money on advertising, particularly to the consumer.

Drugs: the 2006 awards

Every year, Prescrire recognises the new drugs that offer the greatest tangible improvements for patients.

Pharmaceutical companies and transparency:
the 2006 Information Awards

Prescrire encourages pharmaceutical companies to present clinical evaluation data in a transparent fashion.

Drug packaging: the 2006 awards

Although packaging plays an important part in good drug use, it is often neglected by pharmaceutical companies and drug regulatory agencies.

Simple bacterial urinary infections often clear up spontaneously but slowly

In general, simple acute cystitis clears up on its own without complications, but slowly. Antibiotic treatment reduces the duration of the discomfort. The complications of kidney infections are rare but serious, and justify early recourse to antibiotic treatment.

Corticosteroids: adverse cutaneous effects,
even when inhaled

The adverse cutaneous effects of corticosteroids are not restricted to oral administration. The minimum effective dose of inhaled corticosteroids should be prescribed, especially in older patients.

Mental health: putting patients first

The current emphasis on mental health should not be seen as an opportunity to medicalise everything or to propose insufficiently evaluated drugs.

Manufacturing diseases in order to sell drugs

It is in the interest of pharmaceutical companies for more and more of life’s events to be deemed to require drug treatment.

Pharmaceutical companies' "compliance support programmes" should not be legalised

Pharmaceutical companies are offering more and more drug "compliance support programmes". These industry-driven programmes should be banned.

Type 2 diabetes in children:
prevention is a priority

Type 2 diabetes is currently on the increase in children and adolescents in rich countries, in parallel with the rise in obesity. The treatment of this serious disease is poorly evaluated in children. Prevention is a priority.

Arterial hypertension:
how do you define normal levels?

Defining normal levels to assess risk or to decide on drug treatment is of no value unless the effectiveness of prescribing treatment above these levels is proven.

Alzheimer's drugs: can cause trembling and aggravate parkinsonian symptoms

In patients with Alzheimer's-type dementia taking cholinesterase inhibitors, treatment should be halted if falls, difficulties in walking or Parkinsonian symptoms occur, given the limited and short-lived benefits of these drugs.

Relevant health information for empowered citizens

Citizens need health information that enables them to make informed choices. They do not need ads from pharmaceutical companies disguised as "information".

Disaster relief: donations of medicines
do more harm than good

Many of the drugs donated following the disasters in Pakistan and Indonesia were unusable and had to be incinerated. It is better to help countries to buy the drugs they need.

Serious post-traumatic stress: improvement often occurs without drug treatment

In cases of stress as a reaction to a serious trauma, listening, moral support and, for some patients, psychotherapy, are the main measures to take.

Drugs for rare diseases:
contrasting results in Europe

The EU Regulation on "orphan drugs" signals progress, but with strong limitations.

Pharmaceutical companies' compliance support programmes: no thank you!

Pharmaceutical companies are really not the best people to remind patients to take their medicine. A French proposal for companies to be allowed to run compliance support programmes must be defeated.

Direct-to-consumer advertising for prescription drugs: abuse and confusion

By definition, and as long experience has proved, pharmaceutical companies cannot provide impartial information on their products. They advertise them.

Drugs: not enough comparative data

Pharmaceutical companies and public authorities sometimes connive to cover up an unfortunate truth: the lack of comparative data on new drugs.

The medicalisation of life: drugs and more drugs!

With their "disease information campaigns", pharmaceutical companies have just one aim, and that is to increase their drug sales. Even if it means exaggerating the seriousness of illnesses or going so far as to "invent" new ones.

Conflicts of interest within the French drug regulatory agency: much remains to be done

It is imperative that French drug regulatory agency experts remain impartial in fulfilling their public service role.

Omega-3: no reduction in the risk of cardiovascular disease, cancer or dementia

Omega-3 fatty acids are thought to help prevent numerous diseases, but their effectiveness in preventing cardiovascular disease, cancer and dementia has not been clinically proven.

Cholesterol: pravastatin and simvastatin
are the first-line drugs

In cardiovascular prevention, pravastatin and simvastatin are the cholesterol-lowering statins that have the longest track record and whose effectiveness is the most convincing.

Type-2 diabetes: diet and physical activity can prevent or delay onset

In people at high risk of type-2 diabetes, the most effective means of prevention are losing weight and increasing physical activity.

Pharmacovigilance: valuable data from the French regional centres

The annual French pharmacovigilance conference gives a glimpse of the reports made by health professionals to the regional pharmacovigilance centres, and a peek into the French pharmacovigilance database.

Cholesterol: a new drug combination brings no proven clinical benefit but an additional risk

In cardiovascular prevention, simvastatin is a first-line cholesterol-lowering drug. The combination of ezetimibe and simvastatin has no proven additional clinical benefit, but carries an increased risk of muscular damage.

Giving up smoking: motivation and moral support first, and then, if necessary, nicotine

The role of drugs in helping smokers quit remains secondary. If medicinal aid is deemed necessary, it is best to keep to nicotine.

Nutritional supplements: caution!

There is an urgent need to evaluate nutritional supplements before they are put on the market.

Herbal capsules: warning

Capsules containing powdered crushed plants are different from powders for herbal teas and tea bags.

Application of the World Trade Organisation
drugs agreement: still nothing

The World Trade Organisation (WTO) stated that it had introduced the necessary flexibility to patent laws to give poor countries access to recent drugs. Three years later, nobody has yet made use of this "flexibility".

Neuroleptics: the cause of deep vein thrombosis and pulmonary embolism

The risk of deep vein thrombosis should be taken into account before deciding to prescribe treatment with neuroleptics, and patients should be monitored.

Hyperactivity in children: risk of hallucinations with methylphenidate

In children with attention deficit hyperactivity disorder (ADHD) who continue to exhibit disturbed behaviour in spite of non-drug treatment, methylphenidate is a last-resort symptomatic treatment. The usual dose sometimes causes visual and tactile hallucinations. If this occurs, treatment should be halted immediately.

Nicotinic acid for lowering cholesterol:
too many drawbacks

Short- or long-acting nicotinic acid causes too many adverse effects to be used as a treatment for high cholesterol.

Inhaled insulin: no proven benefits and too many unknowns concerning risks

Subcutaneous injection remains the standard way of administering insulin to diabetics.

Increase in congenital malformations with some antidepressants, in particular paroxetine

Antidepressants are implicated in the risk of congenital malformation. Given the extent of the risk, especially with paroxetine, the treatment of pregnant women should be carefully weighed.

"Metabolic syndrome": an artificial construct
that does not improve treatment

The diagnosis of "metabolic syndrome", whose definition varies from one source to another, is of no use when it comes to improving patients' treatment. It is better to tackle each component of the "syndrome": obesity, diabetes, arterial hypertension and lipid disorders.

Rimonabant for the treatment of obesity:
a few kilos less but too many unknowns

Rimonabant, widely trumpeted in recent months as the miracle cure for obesity, "metabolic syndrome" and tobacco dependency, has turned out to be much ado about nothing.

Oral medicine syringes graduated by weight:
not such a good idea after all

Syringes graduated according to the child's weight seem convenient, but they are a source of error. It is time to promote more reliable systems.

A drug's brand name gives little indication
of the substance(s) it contains

By looking for the International Nonproprietary Name (INN) on the packaging or in the patient leaflet, it is possible to identify whether a drug contains several substances or not, irrespective of the commercial name.

Restless leg syndrome: unpleasant but benign

Treatment of restless leg syndrome is based on simple ways to improve patients' sleep and comfort. The drugs currently on offer have a negative benefit-harm balance.

Food irradiation:
no proven risk but doubts remain

All the published data on the harmlessness of food irradiation is reassuring. But there are still unanswered questions which should incite caution.

Clinical drug trials in France:
all too often results not published

All too often, clinical trial results remain unpublished, especially if they do not confirm the authors' premise. Increased transparency is crucial.

Acupuncture and headaches: no specific effect

Three trials have shown that acupuncture using the traditional pressure points is no more effective in preventing headaches than needles being applied at random.

Fatal slimming aid sold in pharmacies:
bending the spirit of the law

Slimming aids based on a compound containing powdered thyroid extracts, sold under a distorted interpretation of a 1980 law, are implicated in a death.

International nonproprietary name (INN):
to identify a drug with certainty

The International Nonproprietary Name (INN) is a drug's real name, making it possible to identify a drug, irrespective of its commercial name.

Down's syndrome: appropriate monitoring
can improve the quality and length of life

It is possible to facilitate the social integration of people with Down's syndrome, and to increase their life expectancy by treating their cardiac and infectious problems.

Intense phototherapy treatment for newborns:
monitor temperature closely and often

A child died from excessive heat in a phototherapy device. This death could have been avoided by close monitoring of the infant's temperature.

Vaccine against pneumococcus:
from the age of two months

In France, routine vaccination of children against pneumococcus would avoid more than 10 deaths, several dozen cases of meningitis and hundreds of hospitalisations each year, at the cost of one case of serious allergic reaction.

Cholesterol: watch out for the adverse effects
of rosuvastatin

A review of the adverse effects of rosuvastatin shows that this drug has given rise to more reports of adverse effects on the kidneys and muscles than other, currently available drugs in the same class.

Isotretinoin and acne: prevent major risks
to the foetus

The use of isotretinoin is heavily circumscribed, so as to limit the major risk of foetal malformation.

Hyperactivity in children with attention deficit disorder: methylphenidate only as a last resort

Behaviour therapy is effective in most cases of hyperactive children with attention deficit disorder. Methylphenidate must remain a last resort, particularly because of the risk of serious adverse effects, including fatal cardiac effects.

Trimetazidine: a trigger for parkinsonism

New cases of Parkinsonism caused or aggravated by trimetazidine have been reported in Spain and France. These disorders are reversible, which justifies halting this treatment and not prescribing it for new patients.

Pharmaceutical sales representatives: no hopes for improved care

Prescrire is suspending its sales rep monitoring network: it has done its job in proving that doctors must seek their drugs information elsewhere.

French drug regulatory agency:
the battle for transparency

Transparency is making slow progress at the French Health Products Safety Agency … and some bad habits are coming to light.

Wear gloves during nursing care,
as well as washing hands

Wearing gloves is essential in many nursing situations to protect patients and those caring for them, but hand washing is important too.

Migraine: which preventive treatment?

Depending on the frequency of migraines and their effects on day-to-day life, a preventive drug treatment, notably propranolol, can be prescribed on a case-by-case basis.

Mammography screening:
adverse effects warning

Breast cancer screening by mammography can lead to serious adverse effects.

Drugs authorisation: what's the rush?

It is in patients' best interests for drugs to be properly evaluated before being put on the market.

Pharmaceutical companies' compliance aid programmes: no to trickery

Companies are trying to get a new form of advertising legalised in France, on the sly.

Don't confuse the I.N.N. with generic drugs

The International Nonproprietary Name (INN) is a drug's real name. A generic is simply a copy of a drug.

Menopause: hormone treatment aggravates urinary incontinence

Contrary to current thinking, hormone replacement therapy for menopausal women does not afford protection against urinary incontinence, which appears in fact to be an adverse effect of this treatment.

Adverse drug effects in children too

Adverse drug effects are as frequent in children as in adults. It is vital to detect and report them to regional pharmacovigilance centres to foster an improved understanding of drug use in children.

Menopause: risk of breast cancer and
uterine cancer with tibolone

Tibolone has no advantage over combined oestrogen and progestogen therapy for the treatment of disorders associated with the menopause. It carries an increased risk of breast cancer, cancer of the uterus, and stroke.

Pregnancy: beware of nonsteroidal anti-inflammatory drugs

No nonsteroidal anti-inflammatory drugs should be taken, even briefly, in the second half of pregnancy. Pregnant women should be prescribed painkillers that do not put the foetus at risk, paracetamol in particular.

Cardiovascular prevention and omega-3s:
no proven benefits

Omega-3s have no proven cardiovascular prevention benefits. Changing to a "Mediterranean diet" is preferable.

Control of chemical substances:
the EU's "REACH" regulation

In 2006, Europe will have to strike a balance between the chemicals industry and public health.

Breast cancer screening in France

In 2003, mammography screening led to some 43,000 diagnoses of breast cancer in France. Around 70,000 women had abnormal results which subsequently proved to be a false alarm.

Incentive gifts to health professionals: conditioning begins at university

Medical students, regrettably, grow accustomed to accepting gifts from pharmaceutical companies.

Prescrire: independent and transparent

Prescrire has relied solely upon its subscribers for funding since 1993, and has been making its accounts public since 1992.

Alzheimer's disease:
drugs cause a number of adverse effects

Anticholinesterase inhibitors are not very effective in treating Alzheimer's disease. They expose the patient to potentially serious adverse effects, which are often similar to the symptoms of the illness itself, and which can appear or be exacerbated as a result of drug interactions.

International nonproprietary names:
for a safer medicine chest containing fewer drugs

Using a drug's International Nonproprietary Name (INN) is a valuable aid to patients, carers and medical staff. In particular it makes it possible to sort out the medicines in the medicine chest safely.

Transparency regarding conflicts of interest:
who benefits from the delay?

"Experts" speaking about drugs in a public gathering or in the media should divulge any links with the pharmaceutical companies concerned. This French measure dating back to 2002 is not scheduled to be implemented until 2007, or even 2008!

French drugs regulatory agency still
dragging its feet on transparency

The French drugs regulatory agency is dragging its feet with regard to its obligations to be transparent. But the delay in implementing the European Directive into French law does not exonerate the agency from its obligations, since European Directives are deemed to have a "direct effect" in the countries that are late in incorporating them.

The 2005 information awards

Prescrire encourages pharmaceutical companies to share all the clinical evaluation data.

Drugs packaging: still too much evidence
of poor quality in 2005

There has been no overall progress in the field of packaging, even though it is a vital factor for the correct use of drugs.

2005 drugs review in France:
a high price to pay for non-progress

2005 was remarkable for its lack of therapeutic improvements and persistent governmental failings.

2005 drugs review: insufficient progress

Tangible therapeutic improvements for patients were few and far between in 2005. And too many new drugs have a markedly negative benefit-harm balance.

Gastroesophagal implants: a medical device causes serious adverse effects

The regulations governing the sale of medical devices are less stringent than those for medicines.

I.N.N.: for a better knowledge of drugs

A drug's International Nonproprietary Name, or INN, is a valuable aid for patients and doctors. Identifying drugs by their real name helps to avoid the re-use of contra-indicated drugs or medicines associated with sometimes serious adverse effects.

Herbal remedies:
patients do not always inform their doctors

According to a German study, patients rarely inform their doctors that they are taking herbal remedies. And yet there is a real risk of interactions between herbal remedies and drugs.

Fentanyl patches:
safe disposal after use is essential

Fentanyl is an opiate-based analgesic, and fentanyl patches still contain the substance after use. Procedures for their safe disposal must be followed to avoid the risks associated with this opiate.

Hot flushes during menopause: dubious benefit of some phytoestrogens and risks for the uterus

Phytoestrogens, sold as a treatment for menopausal hot flushes, have not been adequately evaluated. Confirmed risks, especially for the uterus, need to be weighed up against a limited benefit.

Drugs advertising: increasingly costly

Advertising, as opposed to research, is eating up a growing proportion of pharmaceutical companies' budgets.

Medicines and public health risks: the European Commission is not demanding enough

The European Commission has adopted a minimalist definition of the risk posed to public health by insufficiently evaluated drugs.

Treatment options:
tangible improvements for patients

The publication of Prescrire's 2005 report gives health professionals the facts they need to update the list of drugs available for use.

First major French study on serious adverse events related to healthcare

Every year in France 70,000 to 110,000 hospitalisations, as well as 120,000 to 190,000 serious adverse events in hospitalised patients, appear to be preventable.

Adverse effects of healthcare:
learn from mistakes to improve care

Identifying, describing and understanding healthcare-related errors allows lessons to be learned, in order to improve patient care.

International nonproprietary name:
the campaign goes on

The INN, or international nonproprietary name, is a drug’s real name. Including it on medicine packaging can only help improve the use of drugs.

Pregnancy in an opiate-dependent patient:
preventing complications

Monitoring a patient dependent on opiates (heroin, etc.) during her pregnancy requires cross-disciplinary collaboration. Heroin replacement therapy (methadone or buprenorphine) improves the prognosis for both mother and child.

Nonsteroidal anti-inflamatory drugs:
adverse effects in all parts of the intestine

Nonsteroidal anti-inflamatory drugs (NSAIDs) have adverse digestive effects that affect the stomach and the entire intestine, not just the duodenum.

Transparency of the drug regulatory agency:
France drags its feet

The incorporation of a major EU Directive on medicines into French law has been delayed. This delay particularly affects measures aimed at improving the transparency of the French drug regulatory agency’s activities and decisions.

Clinical trials in France:
new rules for the protection of subjects

The ethical issues related to clinical trials are not just confined to participants’ informed consent.

New drugs: prices bear no relation to reality

Prices of new drugs often have nothing to do with assessment data or sales volumes.

Diabetics : self monitoring of blood glucose
can be useful

Self-monitoring of blood glucose is a useful tool for diabetics who are motivated to manage their illness.

Foods enriched with phytosterols or phytostanols:
no place in cardiovascular prevention

People concerned about cardiovascular prevention would do better to follow a Mediterranean diet than to eat foods enriched with phytosterols.

Psoriasis treatment in adults:
a shared decision with a well-informed patient

The various treatments for psoriasis do not guarantee recovery, and some expose the patient to potentially serious adverse effects. The choice of treatment should be discussed with the patient.

Immunostimulants, Biostim° and others:
finally taken off the market

Drugs based on bacterial extracts and sold as "immunostimulants" have at last been withdrawn from sale, since they have no proven efficacy and can cause sometimes serious adverse effects.

The French drug regulatory agency:
unacceptable delays

The French drug regulatory agency denies dragging its feet and favouring the interests of pharmaceutical companies. And yet its slowness in making decisions benefits drug companies rather than public health.

Sick leave: restrictions ill-founded

Monitoring of sick leave is being further reinforced as part of a drive to clamp down on "abuses". And yet there are no absolute medical rules on the ideal amount of time off work for illness.

Medicines for paediatric use:
a move towards better European regulation

MEPs improved the proposed European Regulation on Medicinal Products for Paediatric Use on its first reading. But the European Commission and national governments can still challenge these measures.

Gene patenting: the legal battle goes on

Several European patents on genes linked to hereditary cancers have been revoked or restricted, following complaints from cancer research institutes.

Drugs advertising:
the influence of opinion leaders

Pharmaceutical companies like to get influential members of the medical profession – opinion leaders – involved in their sales effort.

Tuberculosis: the use of masks
in preventing transmission

In situations where there is a high risk of transmission of serious infections via the respiratory tract, masks offer protection to nursing staff and the patient’s entourage.

Dextropropoxyphene combined products: withdrawn in a third European country

After Switzerland and the United Kingdom, now it is Sweden's turn to announce the withdrawal of the combined products paracetamol + dextropropoxyphene. What is France waiting for?

Alprazolam: patient information leaflet ambiguous concerning use in children

The patient information leaflet accompanying alprazolam-based anxiolytics in France mentions use in children, despite the lack of a specific evaluation for this group of patients.

Antiviral agents in flu prevention:
possibly in addition to vaccination in some cases

Vaccination is the prophylaxis against flu. Antiviral agents could possibly be prescribed as well when there is a very high risk of complications in those whose health is fragile.

International nonproprietary name (INN):
calling a drug by its real name

The Association Mieux Prescrire, the Fédération Nationale de la Mutualité Française and UFC - Que Choisir, launch the campaign "INN (international non-proprietary name): calling a drug by its real name".

Pharmaceutical companies in crisis:
a global phenomenon

Growing numbers of observers, critical of pharmaceutical companies' excesses, are demanding new regulations.

Sales reps: a charter with no visible impact

Pharmaceutical companies have made a lot of noise about adopting a "sales reps' charter". But according to independent observers, this charter has had no effect on sales reps' practices.

Drugs advertising to consumers: on the increase

In France, pharmaceutical firms are now allowed to advertise to the consumer drugs that will no longer be reimbursed, as early as six months before actual removal from the list.

Drug prices and reimbursement:
making better use of public funds

Public funds should be used in service of quality care, not to purchase "new" drugs at any price.

Topical immunosuppressants:
increased risk of cancer

The negative benefit-harm balance of picrolimus and tacrolimus applied topically in the treatment of atopic dermatitis (alias atopical eczema) is confirmed by the onset of sometimes fatal cancers, including in children.

Bupropion: not during pregnancy

The overall benefit-harm balance for bupropion, sold as an aid to stop smoking, is negative. New data reveal a risk of cardiac malformation in newborns as a result of exposure during pregnancy. Yet another reason not to use it.

A generous price for a drug that offers no therapeutic advantage

A hefty price has just been agreed for ximelagatran, a new anticoagulant, whereas older anticoagulant treatments are better evaluated and have a favourable benefit-harm balance.

Pharmaceuticals advertising: proven to promote prescription of the newest drugs

Pharmaceuticals firms invest huge sums in advertising to persuade doctors to prescribe their new drugs. A strategy that pays off for the industry, but not for patients and public health.

Arterial hypertension: diuretics as a front-line treatment for diabetics too

The treatment of arterial hypertension with diuretic drugs improves hypertensive patients' overall cardiovascular prognosis, in diabetics as with others.

After a myocardial infarction:
a Mediterranean diet is recommended

A diet rich in cereals, fruit and vegetables can reduce the risk of another coronary event.

Emptying injectable solutions into basins:
another fatality

Pouring injectable solutions into a basin carries the risk of contamination, and of mixing up different products. Some simple measures would help prevent potentially fatal errors.

Piracetam: not for use on stroke patients

Piracetam's official indication as a treatment for the after-effects of stroke has at last been withdrawn. The drug is still on sale however, and is refundable in other situations, even though its medical benefit is insufficient.

AIDS: a fake drug banned at last

Thanks to the vigilance of patients' groups, Viralgic° has at last been banned by the French drug regulatory body. Since 2001, this plant-based product had been sold as a drug against the AIDS virus, without a marketing authorisation for this purpose.

Type 2 diabetes: in some patients, statin therapy reduces cardiovascular risk

Statin cholesterol-lowering therapy reduces the cardiovascular risk in some type 2 diabetes patients. It should not be routinely prescribed and it is important to take into account the adverse effects of statins, the patient’s cholesterol level and the presence of other risk indicators.

Stress urinary incontinence in women:
pelvic muscle training is the first option

The initial treatment for stress urinary incontinence in women is pelvic floor exercises. Surgery should be considered on a case- by-case basis, generally as a last resort. Drug treatment is not appropriate.

Celecoxib still on the market: for whose benefit?

Patients are still exposed to the dangers of a drug that offers no therapeutic advantage.

Euthanasia: the case of Belgium

In Belgium, around twenty deaths by euthanasia take place monthly, some in the home. The doctor can get the necessary drugs in a "kit" from the local pharmacy.

Diagnostic tests: improved interpretation
when accompanied by a clinical report

When the prescription of a diagnostic test is accompanied by a clinical report, the interpretation of the results is improved.

Excessive alcohol consumption:
brief interventions can reduce consumption

General practitioners are well placed to identify people whose alcohol consumption is excessive, or who are at risk, and to intervene to help them reduce their alcohol consumption.

Type 2 diabetes:
insulin treatment is no cause for alarm

Insulin treatment to prevent hyperglycaemia and its related complications may be necessary in some uncontrolled type 2 diabetes patients. Patients are more likely to accept and continue the treatment if it is not made to sound alarming and they are well informed.

Stroke: prevent recurrences

After a stroke, there is a high risk of a recurrence or of a cardiovascular event. This risk can be averted through treatment with the usual cardiovascular prevention drugs or, in some cases, carotid surgery.

Parkinson's disease:
hypersexuality under dopaminergic drugs

Dopaminergic drugs used to treat Parkinson's disease sometimes cause a huge increase in libido, leading to inappropriate behaviour. The problem is resolved when treatment is stopped.

Analgesics: reducing the number of tablets
per packet reduces overdoses

Following the example of Finland, and then France, in 1998 the UK reduced the number of analgesic tablets per packet. A 30% drop in the number of deaths shows the effectiveness of this measure.

Neuroleptics:
increased mortality among elderly patients

Deaths among patients being treated with newer neuroleptics are higher among the elderly. This increased mortality could also apply to other, less recent neuroleptic drugs.

Nutrition: reduce consumption
of added simple carbohydrates

Excessive consumption of added simple carbohydrates damages health, contributing especially to overweight and obesity. A drop in consumption is desirable, especially among young people.

Drug regulatory agencies:
their public role should be reinforced

Irish citizens ask their prime minister to restore the drug regulatory agency's role as defender of the public interest.

INN: for the best use of drugs

Thinking in terms of International Nonproprietary Names (INN) is essential for the best use of drugs.

Antioxidants: ineffective in preventing cancer
and cardiovascular disease

"Antioxidant" treatments have no proven effectiveness against cancer or cardiovascular disease. There is no justification for their routine use in a population that enjoys a varied diet.

Bupropion: not recommended,
especially during breastfeeding

Bupropion passes into breast milk and exposes the breastfed baby to the risk of convulsions. One more reason not to use this drug, which is intended to help people quit smoking.

Bipolar disorder: lithium is the best treatment

A long-established drug, lithium, remains the leading treatment for preventing the recurrence of manic episodes in patients suffering from bipolar disorder, even though more recent drugs are available.

Pharmaceutical sales reps: no thank you!

The more visits French doctors receive from sales reps, the more likely they are to prescribe antibiotics for acute rhinopharyngitis.

Irradiation:
a controversial food preservation method

Although strongly advocated by international organisations, food irradiation is proving unpopular, mainly because of the hostility of consumer organisations.

Levonorgestrel: the best morning-after pill

A single dose of 1500 micrograms of levonorgestrel in the hours following unprotected sexual intercourse is the best morning-after contraception method.

Anti-allergy drugs:
beware of confusion with brand names

Three drugs containing cetirizine are available over the counter in France. Their brand names, which have no connection with the international nonproprietary name (INN), risk confusing patients.

Head lice and scabies: avoid lindane

Lindane, still used in some head lice and scabies treatments, does more harm than good. There are other, better alternatives.

Pharmacovigilance:
independent recommendations

A group of independent drug bulletins has published the "Berlin Declaration", a series of recommendations to highlight and especially to prevent adverse drug effects.

Female condoms: a welcome alternative

Female condoms enable women to be in control of their own sexual protection. Their effectiveness as contraceptives and in preventing infection, especially against HIV, is comparable to that of the male condom.

Visits from sales reps: still misleading

Pharmaceutical firms' sales reps' visits to health professionals have changed little: they exaggerate the drug's benefits and gloss over the risks

Chickenpox vaccine: should not be systematic

Chickenpox vaccination should be restricted to certain people.

School canteens: no to salt on the tables

Children eat enough salt already. Salt on the table, especially in the school canteen, is not good for them.

Drug interactions: a new source of information

A new information resource helps Prescrire's subscribers to understand and prevent adverse effects caused by drug interactions.

Paediatric drugs: Europe can and must do better

The European Commission's draft Regulation on paediatric drugs needs amending.

Drugs: the implications of pricing freedom

In the USA, a pharmaceutical company raised the price of one drug five-fold.

Pharmaceuticals advertising: a bitter blow

Pfizer has been sanctioned in France for sending out a misleading letter to health professionals. The letter has been banned and Pfizer was forced to send out a rectification.

Treatment options: drugs to be avoided

Every January, Prescrire publishes an independent review of therapeutic advances made over the previous year.

The pharmaceuticals industry and patients’ groups: dangerous liaisons

It is not in the best interests of patients’ groups to rely upon the pharmaceuticals industry for their funding and information.

Poliomyelitis: vaccinate adults too, even in Europe

Children must be systematically vaccinated against poliomyelitis, and adults should be given boosters every 10 years.

Dermatology and pregnancy: no retinoids,
not even topical

Oral retinoids, used in particular against acne, must absolutely be avoided during pregnancy as they can cause foetal malformation. As a precaution, it is wise to steer clear of topical retinoids too.

Drugs packaging: all too often ignored

The quality of drugs packaging, too often ignored by pharmaceutical companies and drug regulatory agencies, fluctuates from one extreme to the other.

Drugs in 2004: irresponsible risks being taken

Drug regulatory agencies must not lower their standards for new medicines in response to the lack of therapeutic advances.

New drugs in 2004: a lack of innovation

In 2004, therapeutic advances were rarer and less significant than in 2003.

Therapeutic advances: the industry is at a loss

Real therapeutic advances are increasingly hard to come by. Now is perhaps the time to consider new avenues.

Piracetam: risk of haemorrhage

The risk of haemorrhage with piracetam argues against use of this drug, which has no proven clinical benefits.

Trimetazidine: risk of Parkinsonism

Cases of Parkinsonism have been attributed to trimetazidine. With no proof of the drug's effectiveness, there is no justification for running such a risk.

Nutrition-based disease prevention: let's act now

The French public health law paves the way for preventing the development of diet-related chronic illnesses. But it is only the first step.

Coxibs: the ongoing saga

Cardiovascular, renal and cutaneous effects… the scale of adverse effects of coxib NSAIDs is becoming increasingly apparent.

Treatment options: Prescrire's detailed review

A recap of the therapeutic advances made in 2004, culled from hundreds of pages of reviews.

Medicines for paediatric use: meeting real needs

One of many problems: an analgesic for children was approved on the basis of an inadequate clinical evaluation.