Archives : 2022

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.

1 December 2022

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.

1 December 2022

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.

1 December 2022

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.

1 December 2022

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.

1 December 2022

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.

1 December 2022

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.

1 November 2022

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.

1 November 2022

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.

1 November 2022

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.

1 November 2022

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?

1 November 2022

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.

1 November 2022

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.

06 October 2022

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.

1 October 2022

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.

1 October 2022

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.

1 October 2022

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.

1 October 2022

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.

1 October 2022

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.

1 October 2022

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.

1 September 2022

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.

1 September 2022

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.

1 September 2022

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?

1 September 2022

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.

1 September 2022

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.

1 September 2022

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.

1 September 2022

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.

1 September 2022

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.

1 July 2022

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.

1 July 2022

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.

1 July 2022

Spotlight: Archives

Spotlight

2022

Dapivirine vaginal ring in the prevention of HIV

Europe and medicines

Opioids: endocrine disruptors

Impending changes to European pharmaceutical regulations: part 1

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

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

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

A change of paradigm

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

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

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

Etifoxine: a dangerous drug still on the market

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

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

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

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

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

Antibiotic resistance: a growing threat

Oral use of injectable drugs: uncertain efficacy and known risks

Mycophenolic acid and pregnancy: genotoxicity, malformations, spontaneous abortions

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

Moderate use of medicines

Imiquimod 3.75% cream (Zyclara°) in actinic keratosis

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

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

The European Implementing Regulation on Pharmacovigilance Activities

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

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

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

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