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In Prescrire's Spotlight

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.  Full article available for download by subscribers 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?  Full article available for download by subscribers 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. Full article available for download by subscribers 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? Full article available for download by subscribers 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

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Enjoy these features, and more, in our upcoming issues COMING SOON• Lecanemab in early Alzheimer's disease • A brief review of Prescrire's drug ratings in 2025 • Clomifene in utero • EMA's response to Prescrire on its handling of competing interests > Subscribe now 1 March 2026

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ 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 1 January 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Subscribe today for full access to top-quality content from Prescrire International  SUBSCRIBE NOW!  Enjoy access to subscriber-only content available on our website, including every article published in Prescrire International since 1992. Prices for a one-year subscription start at 165 euros (less for students and residents of lower-income countries). 1 January 2022

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Follow Prescrire International on LinkedIn and Facebook Keep up with the latest from Prescrire's editors, and support our values of independence and quality information, first and foremost in the interest of patients. Click here to > Follow us on LinkedIn or > Follow us on Facebook 1 January 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Receive the free, monthly "Independent Drug & Healthcare Newsletter" Click here to sign up for the free Newsletter from the editors of the non-profit journal Prescrire International, with highlights of the contents of the latest issue. 1 July 2022

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Drugs to avoid, in the name of better patient care   DRUGS TO AVOID - 2026 UPDATE  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. > Read more

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Read more All the subjects in Prescrire's Spotlight >

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