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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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Spotlight

100 most recent
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A centralised European Medical Devices Agency, and soon!

Editorial In July 2025, the national authorities for health products of 17 EU countries called for the creation of a centralised European agency for medical devices. They argued that it would strengthen cooperation between countries, by coordinating their vigilance and risk-assessment activities in an increasingly complex market. This would make it possible to better protect patients, while being more cost-effective for member states, and reducing the administrative burden on medical device companies. The hopes raised by their remarkable position statement were immediately dashed by the European Commission's announcement of a reform with quite different aims.
Full article available for download (FREE)

1 March 2026

Bempedoic acid (Nilemdo°) or bempedoic acid + ezetimibe (Nustendi°) in cardiovascular prevention

Marketing Authorisations Bempedoic acid has been authorised in the European Union, alone or as part of a fixed-dose combination with ezetimibe, for use in primary or secondary cardiovascular prevention, either as monotherapy or in combination with other cholesterol-lowering drugs, when statins are considered insufficiently effective or cannot be used, which is often due to their adverse effects.
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1 March 2026

Trastuzumab emtansine (Kadcyla°) in certain breast cancers, after neoadjuvant treatment with trastuzumab + chemotherapy and surgery

Marketing Authorisations Trastuzumab emtansine (Kadcyla°) has been authorised in the European Union since 2019 for use as monotherapy after surgery in women or men with breast cancer overexpressing HER2 who have residual invasive disease despite treatment with a combination of chemotherapy + HER2-targeted therapy before surgery. This marketing authorisation was based on data from an interim analysis of a non-blinded randomised trial. In light of current data, does trastuzumab emtansine compared with trastuzumab extend survival in this situation? Does it have fewer or milder adverse effects?
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1 March 2026

Azithromycin: some indications refined and others removed due to increased bacterial resistance

Marketing Authorisations Due to an increase in bacterial resistance to azithromycin, the European Medicines Agency has reviewed the harm-benefit balance of this macrolide antibiotic. As a result, certain indications have been refined, some have been removed, and warnings about the risk of bacterial resistance have been added. Rational measures for an antibiotic that is useful in a variety of situations.
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1 March 2026

GLP-1 agonists in pregnancy: poorly elucidated risks that warrant a highly cautious approach

Adverse effects Dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide and tirzepatide are all teratogenic and fetotoxic in animal models. What about in humans? This article summarises the data on in-utero exposure to GLP-1 agonists identified through our literature search. Do these drugs increase the risk of malformations or have other fetal, neonatal or obstetrical consequences? And what are the long-term effects on children exposed in utero?
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1 March 2026

Countering the influence of the pharmaceutical and medical devices industry in Europe

Advancing Healthcare Policy Prescrire signed joint letters to the British, Irish and European authorities calling on them to prioritise the interests of patients over those of industry.
Full article available for download (FREE)

1 March 2026

Drug shortages: proposed European legislation

Advancing Healthcare Policy Prescrire has suggested improvements to the European Commission's Critical Medicines Act.
Full article available for download (FREE)

1 March 2026

EMA: electronic product information

Advancing Healthcare Policy Prescrire contributed to a consultation by the European Medicines Agency on the content, delivery, publication and use of electronic product information (ePI).
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1 March 2026

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.
Full article available for download (FREE)

1 February 2026

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.
Full article available for download by subscribers

1 February 2026

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