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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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100 most recent
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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?
Full article available for download by subscribers (2 pages)

1 May 2024

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

1 May 2024

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.
Full article (4 pages) available for download (free)

1 May 2024

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.
Full article available for download (free)

1 May 2024

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.
Full article available for download (free)

1 April 2024

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

1 April 2024

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.
Full article available for download (free)

1 April 2024

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.
Full article available for download by subscribers

1 April 2024

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)
Full article available for download by subscribers

1 April 2024

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.
Full article available for download (free)

1 April 2024

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