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In Prescrire's Spotlight

Phasing out patient leaflets in paper form: eco-responsible or irresponsible?  Editorial  In 2023, the European Commission embarked on a thorough revision of Europe's pharmaceutical legislation. One of the proposed changes is to gradually phase out package leaflets in paper format and replace them with an electronic version. Full article available for download (free) 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Selinexor (Nexpovio°) in relapsed or refractory multiple myeloma: not acceptable  Marketing Authorisations   For patients with relapsed or refractory multiple myeloma, various combinations of antineoplastic drugs extend survival. Selinexor, an exportin-1 inhibitor, has been authorised in the European Union for use in multiple myeloma: in combination with bortezomib and dexamethasone after at least one line of treatment; and in combination with dexamethasone after at least four lines of treatment. Full article available for download by subscribers (3 pages) 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Bupropion + naltrexone (Mysimba°) for weight loss: set to be withdrawn from the market in the European Union?  Marketing Authorisations   The pharmaceutical company Orexigen Therapeutics has failed to fulfil its obligation to conduct a post-authorisation trial to assess the long-term cardiovascular adverse effects of the fixed-dose combination of bupropion + naltrexone (Mysimba°), which is authorised in the European Union for use in patients with obesity or who are overweight. Now, 9 years after its authorisation, the European Commission has asked the European Medicines Agency to review its harm-benefit balance. Full article available for download by subscribers 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ In-utero exposure to corticosteroids: increased risk of serious infections during the first year of life  Adverse Effects   A study using Taiwanese healthcare databases, including about 2 million children, assessed the risk of infection linked to in-utero exposure to a corticosteroid prescribed to prevent prematurity-related respiratory distress syndrome. The risk of hospitalisation for a serious infection during the first year of life appeared to be about 25% greater in the exposed children. Full article available for download by subscribers 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Prescrire's review of drug packaging in 2023: reconciling ease of use with safety is an ongoing challenge Drug packaging can be considered high quality if it makes the drug safer and easy to use, and if it is designed to protect people who come into contact with the patient from the risk of poisoning, especially children. Full article (4 pages) available for download (free) 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Prescrire's contribution to the EMA's consultation on the "Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials"  Advancing Healthcare Policy   In the interests of patients, Prescrire's contribution emphasises two points that are fundamental to the quality and safety of health care, and that the EMA must take into account while developing its forthcoming guideline on "non-­inferiority" trials. Full article available for download (free) 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Enjoy these features, and more, in our upcoming issues COMING SOON• Finerenone in chronic kidney disease associated with type 2 diabetes  • Durvalumab with or without tremelimumab in various cancers • Short-term interruption of treatment with a "direct-acting" oral anticoagulant: thrombosis • Environmental impact of drugs  > Subscribe now 1 September 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Covid-19: Follow Prescrire's independent, evidence-based analysis of the pandemic  COVID-19  Prescrire's editors are publishing an ongoing series of articles featuring independent analysis of developments related to the covid-19 pandemic. Useful and practical information, to help health professionals gain a clear and balanced view. 1 November 2023

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ New! "Top Texts of 2023", from the editors of Prescrire International  FREE SPECIAL EDITION  Check out this sampling of texts from Prescrire International, a wholly independent monthly drug bulletin, written by and for healthcare professionals. Inside, top articles from sections dedicated to new drugs authorised in Europe and key information on adverse drug effects, plus our annual update of drugs to avoid. > Click here for your free copy 1 August 2023

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ 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 Facebook and Twitter 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 Facebook or > Follow us on Twitter 1 January 2022

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ 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 - 2024 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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