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Drug & Poison Information Channel

Drug & Poison Information Channel

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It provides up to date, evidenced based, concised drug information to all health care professionals. Supervised by: Ph. Amal Al-Najjar. To communicate,participate and questions: @Amal_alNajjar.

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Channel Posts
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🚦Regulatory Alert: EMA & FDA Move to Revoke Avacopan (Tavneos) Medicine: Tavneos (avacopan) Class: Oral complement C5a-receptor antagonist Indication: Severe, active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) in adults, alongside standard therapy. The Update The European Medicines Agency’s (EMA) committee has recommended revoking the EU marketing authorization for Avacopan, concluding its benefits no longer outweigh its risks. The US FDA is concurrently moving to withdraw the drug on the exact same grounds. The Reason: Data Integrity, Not Safety This transatlantic withdrawal is not triggered by a new adverse event, but by severe data integrity issues regarding the pivotal ADVOCATE trial (n=331) that originally supported its approval: Evidence revealed that trial results were manipulated by unblinded personnel to make the drug appear effective. The original data analysis did not support the conclusion of efficacy. This original, unfavorable analysis was actively hidden from regulatory agencies during the initial approval process in 2021/2022. (EMA CHMP Article 20 Assessment Report (June 2026) & FDA Federal Register Proposal Notice (April 30, 2026)).
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كيف نفهم أرقام الـ (Hazard Ratio) بشكل عام؟ إذا كان الـ HR يساوي 1: العلاجان متطابقان تماماً، ولا يوجد أي فرق في الخطورة بين المجموعتين. إذا كان الـ HR أقل من 1 (مثل 0.58): العلاج الجديد أفضل، لأنه يقلل من احتمالية حدوث الشيء السيء (تفاقم المرض) ويطيل فترة استقرار المريض. إذا كان الـ HR أكبر من 1 (مثلاً 1.5): العلاج الجديد أسوأ، لأنه يزيد من خطر تفاقم المرض بنسبة 50%.
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*Dear Doctor,* I would highly appreciate your participation in our research study titled: *“Effectiveness and Diagnostic Reliability of Tele-dermatology in Primary Care among Family Physicians in Riyadh, Saudi Arabia.”* The survey takes approximately 3 minutes to complete and aims to assess Family physicians’ experiences with virtual dermatology consultations. Participation is voluntary, and all responses are anonymous and confidential. *survey link:* https://forms.gle/PJVigwYeqcdas1Bx6 *Thank you for your valuable time and contribution.*
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For more than 60 years, Metformin has been prescribed to hundreds of millions of people with Type 2 Diabetes. While clinicians knew it was effective, the exact mechanism behind its action remained only partially understood. Researchers at Baylor College of Medicine have now uncovered a crucial aspect of this mystery. Their findings, published in Science Advances, suggest that metformin works directly through the brain, revealing a previously unidentified mechanism. The study focuses on a protein called Rap1 located in the Ventromedial Hypothalamus, a key control center for whole-body metabolism. When metformin reaches the VMH, it switches off Rap1, which activates a group of neurons known as SF1 neurons. These neurons then signal the body to reduce blood glucose levels. In experiments, mice genetically engineered without Rap1 in this brain region showed a striking result: metformin stopped working entirely, even when the mice were on a high-fat diet. Interestingly, other diabetes treatments, such as insulin and GLP-1 receptor agonists, continued to function normally, suggesting that this brain pathway is unique to metformin. Another remarkable finding was the brain’s extreme sensitivity to the drug. While the liver and intestines require relatively high drug concentrations to respond, the brain reacted to doses thousands of times lower than typical oral doses. These insights reshape decades of understanding. Metformin may not simply act through the liver or gut as traditionally believed, it has likely been influencing the brain’s metabolic control systems all along. Researchers are now exploring whether this Rap1 brain pathway could also explain metformin’s other reported benefits, including potential effects on brain aging and longevity. Human studies are still required to confirm these mechanisms, but the discovery opens the door to more precise and targeted diabetes therapies in the future. 📄 Reference: Lin et al. (2025). Low-dose metformin requires brain Rap1 for its antidiabetic action. Science Advances.
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