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In Prescrire's Spotlight

European pharmaceutical legislation: too many opportunities missed  Editorial  On 10 April 2024, members of the European Parliament (MEPs) held a plenary vote on the European Commission's proposals for the revision of European pharmaceutical legislation. Overall, despite a number of welcome advances, MEPs failed to take full advantage of this opportunity to strengthen drug evaluation and patient safety. Full article available for download (free) 1 November 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Herpes zoster vaccine gE/AS01B (Shingrix°)  Marketing Authorisations   The main complication of herpes zoster is persistent neuropathic pain, which can last for months or even years. Immunocompromised patients are at higher risk of developing this complication. Attenuated varicella-zoster virus vaccine is contraindicated in immunocompromised patients, due to the risk of infection with the attenuated virus. A protein vaccine has now been authorised for the prevention of herpes zoster and post-herpetic neuralgia in adults aged 50 years or older and in adults at increased risk of herpes zoster from 18 years of age. Full article available for download by subscribers (4 pages) 1 November 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Tirzepatide (Mounjaro°) in type 2 diabetes  Marketing Authorisations   A tirzepatide solution for subcutaneous injection has been authorised in the European Union for use in adults with type 2 diabetes, either as monotherapy when metformin use is considered inappropriate, or in combination with other glucose lowering-drugs. In these situations, is tirzepatide more effective than a GLP-1 agonist in preventing the complications of diabetes? And what are its adverse effects? Full article available for download by subscribers (4 pages) 1 November 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Hormonal contraception + NSAIDs: deep vein thrombosis and pulmonary embolism  Adverse Effects   A study using Danish healthcare data examined the risk of venous thromboembolism in women who were concomitantly using a hormonal contraceptive and a nonsteroidal anti-inflammatory drug (NSAID) other than aspirin. Full article available for download by subscribers 1 November 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Risankizumab (Skyrizi°) in Crohn's disease after failure of at least one other immunosuppressant  Marketing Authorisations   When a corticosteroid and "conventional" immunosuppressive treatments such as azathioprine are unsatisfactory in a patient with moderate to severe Crohn's disease, adalimumab (an anti-TNF-alpha monoclonal antibody) or ustekinumab (an anti-interleukin-12 and anti-interleukin-23 monoclonal antibody) are immunosuppressants of choice. The anti-interleukin-23 monoclonal antibody risankizumab has also been authorised for use in this situation, or when second-line immunosuppressants have failed. Full article available for download by subscribers 1 November 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Revision of European pharmaceutical legislation: a disappointing vote in the Parliament  Advancing Healthcare Policy   In April 2024, MEPs voted on the European Commission's proposals for the revision of European pharmaceutical legislation. Overall, despite a number of welcome advances, MEPs failed to take advantage of the opportunity to strengthen drug evaluation and patient safety. Full article (2 pages) available for download (free) 1 November 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ French Senate hearing on drug shortages  Advancing Healthcare Policy   Prescrire gave evidence to the Senate as it prepared a resolution on European pharmaceutical legislation. Full article available for download (free) 1 November 2024

DSM: still riddled with conflicts of interests  Editorial  The American Psychiatric Association (APA) has been producing successive versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) since 1952. The aim of the DSM is to propose a definition for every psychiatric disorder. Full article available for download (free) 1 October 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Finerenone (Kerendia°) in chronic kidney disease with albuminuria associated with type 2 diabetes  Marketing Authorisations   Patients with type 2 diabetes are at risk of microvascular disease, which can lead to kidney failure. The aldosterone receptor antagonist finerenone has been authorised in the European Union for use in patients with type 2 diabetes who have developed chronic kidney disease with albuminuria. Does finerenone reduce mortality or the incidence of end-stage kidney disease in this situation? And what are its adverse effects? Full article available for download by subscribers (4 pages) 1 October 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Solifenacin + tamsulosin (Vecalmys°/Vesomni°) in benign prostatic hyperplasia: not acceptable  Marketing Authorisations   A fixed-dose combination of the antimuscarinic drug solifenacin and the alpha-1 blocker tamsulosin has been authorised in France and some other European countries to relieve the symptoms of benign prostatic hyperplasia when monotherapy (of any kind) has been considered insufficiently effective. Full article available for download by subscribers 1 October 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Short-term interruption of treatment with a xaban or dabigatran: sometimes fatal thrombosis  Adverse Effects   A study based on a South Korean health insurance database, including 11 000 patients with atrial fibrillation who were treated with a xaban-type oral anticoagulant or dabigatran and followed up for one year, showed that treatment interruption, even for one day, was associated with a 2-fold increase in the risk of premature death and a 10-fold increase in the risk of stroke, transient ischaemic attack or systemic embolism. Full article available for download by subscribers 1 October 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Environmental impact of drugs: taking drug utilisation data into account  Outlook   Drug residues have been detected in surface water and groundwater in countries around the world. The main source of residues of drugs for human use in the environment is excretion in the urine and faeces. A team of Swedish and Italian researchers has developed a tool for predicting the environmental impact of drugs that takes drug utilisation data into account. Full article available for download by subscribers (3 pages) 1 October 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ European "pharmaceutical package": letter on clinical data exclusivity  Advancing Healthcare Policy  Prescrire was a cosignatory of a letter sent to members of the European Parliament asking them not to extend the regulatory protection afforded to originator medicinal products.  Full article available for download (free) 1 October 2024

¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Enjoy these features, and more, in our upcoming issues COMING SOON• Ivosidenib in certain cholangiocarcinomas • Sutimlimab in cold agglutinin disease • Levetiracetam in utero: long-term effects more clearly defined • Mediator° disaster: the damning appeal judgement  > Subscribe now 1 November 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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