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In Prescrire's Spotlight

Victims of health products: a European opportunity to be seized  Editorial  The 1985 Product Liability Directive established the rules to be followed by member states of the European Union regarding the liability of health product companies when a safety issue arises with their products. The new 2024 version of this directive is more favourable to the victims of such products. Full article available for download (FREE) 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Bedaquiline (Sirturo°) in first-line treatment for pulmonary multidrug-resistant tuberculosis  Marketing Authorisations  During the initial evaluation of bedaquiline in patients with pulmonary multidrug-resistant tuberculosis, the main trial had shown bacteriological efficacy, but also higher mortality. Since then, several randomised trials in hundreds of patients have shown that, compared with the drug combinations previously recommended by the WHO, the use of combinations including bedaquiline make it possible to shorten the duration of treatment by several months, while providing similar bacteriological efficacy and resulting in similar mortality.  Full article available for download by subscribers 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Insulin icodec (Awiqli°) in type 1 or type 2 diabetes  Marketing Authorisations  Insulin icodec is a long-acting analogue of human insulin, designed for once-weekly subcutaneous injection. It differs from human insulin by a few amino acids and the addition of a fatty acid to one of the insulin chains. It has been authorised in the European Union for use in adults with type 1 or type 2 diabetes. Does insulin icodec represent a therapeutic advance over the long-acting insulins available for once-daily use?  Full article available for download by subscribers 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Caftors: liver function abnormalities and possibly cataracts in breastfed infants  Adverse Effects  In 2024, a French team reported elevated plasma levels of liver enzymes, and sometimes bilirubin, in 3 exclusively breastfed infants whose mothers had taken the combination of ivacaftor + tezacaftor + elexacaftor throughout pregnancy and continued treatment while breastfeeding. Full article available for download by subscribers 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Drug-induced sleep apnoea  Adverse Effects  Sleep apnoea is sometimes caused by drugs, but there has been little evaluation of this adverse effect. When a patient develops sleep apnoea, it is important to ask oneself whether a drug could be responsible, and whether their current treatment should be modified. Full article available for download by subscribers 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ European drug regulatory agencies: strategy through to 2028  Advancing Healthcare Policy  The proposed priorities focus too much on new technologies, and not enough on seeking therapeutic advances for patients.  Full article available for download (FREE) 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ EMA: handling the competing interests of its experts  Advancing Healthcare Policy  Prescrire has contributed to a public consultation organised by the European Medicines Agency on its new policy for handling the competing interests of scientific committee members and experts. Full article available for download (FREE) 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Enjoy these features, and more, in our upcoming issues COMING SOON• Gefapixant in refractory or unexplained chronic cough • Semaglutide in excess body weight: new data • Drug-induced impulse control disorders • Minimal clinically important difference > Subscribe now 1 October 2025

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ 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 - 2025 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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