Archives : 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 June 2025

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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1 May 2025

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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1 May 2025

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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1 May 2025

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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1 May 2025

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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1 May 2025

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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1 April 2025

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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1 April 2025

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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1 April 2025

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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1 April 2025

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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1 April 2025

Artificial intelligence: critical thinking is lacking

Outlook A risk of large-scale disinformation, yet wholly inadequate safeguards.
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1 April 2025

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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1 March 2025

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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1 March 2025

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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1 March 2025

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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1 March 2025

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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1 March 2025

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.
Full article (3 pages) available for download (FREE)

1 March 2025

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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1 February 2025

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)

1 February 2025

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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1 February 2025

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

1 February 2025

Spotlight: Archives

Spotlight

2025

Management of conflicts of interest at the EMA: chronic failure

GLP-1 agonists: depression, suicidal thoughts or behaviour (continued)

Calcium supplementation: cardiovascular risks (continued)

Tirzepatide in heart failure in adults with obesity

Melatonin (Adaflex°, Voquily°) in insomnia in children with ADHD

Update to the Declaration of Helsinki

A "prescription" from French civil society for a new pharmaceutical policy

French Senate resolution on the European "pharmaceutical package"

The finances of Association Mieux Prescrire: 2024 annual report

Why drugs should be evaluated in several randomised comparative trials

The Prescrire Drug Awards for 2024

Linzagolix (Yselty°) in uterine fibroids

Cabotegravir (Apretude°) in HIV pre-exposure prophylaxis (PrEP)

Myocarditis linked to messenger RNA covid-19 vaccines (continued)

Sagas

Fexinidazole (Fexinidazole Winthrop°) in sleeping sickness caused by Trypanosoma brucei rhodesiense

Esketamine (Spravato°) in depression after failure of several antidepressants or with a high risk of suicide?

SSRI antidepressants and venlafaxine: increased risk of injuries

Prescrire's ratings of new drugs in 2024

Artificial intelligence: critical thinking is lacking

Public- versus private-sector research: what do they bring to the table?

Exagamglogene autotemcel (Casgevy°) in beta-thalassaemia or sickle-cell disease

Ritlecitinib (Litfulo°) in severe alopecia areata in adults and adolescents

Children exposed to progestogens in utero: excess cancers?

Anticoagulants and heavy menstrual bleeding

Errors related to brand names: the EMA can still do more

Take action

Drugs to avoid in the name of better patient care: 2025 update

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

Mavacamten (Camzyos°) in hypertrophic cardiomyopathy?