14/03/2026
في الفترة الأخيرة ظهر تحذير رسمي من هيئة U.S. Food and Drug Administration لشركة Novo Nordisk بخصوص طريقة الإبلاغ عن بعض الآثار الجانبية المرتبطة بأدوية زي Ozempic و Wegovy و Saxenda.
أنا حابة أوضح موقفي بصراحة:
أنا شخصيا مش بكتب النوع ده من الحقن في الوقت الحالي
مش لأن الدواء اتمنع أو اتسحب من السوق..ابدا الحقن موجودة و بتستخدم ..لكن لأني بفضل دايما أستنى فترة كافية بعد طرح أي دواء جديد..لحد ما يبقى فيه متابعة حقيقية على المدى الطويل ونفهم تأثيراته بشكل أوضح.
بالنسبالي..
تغيير نمط الحياة، وتنظيم الأكل، والحركة، والتعامل مع الأمراض أو الاضطرابات المصاحبة للسمنة و الحالة العامة للشخص ده في رأيي أقوى وأأمن علاج و بيحقق نتايج هايلة للملتزم
ورغم إن القرار ده ممكن يخليني أخسر عملاء ومرضى كتير ..لكن أنا بشتغل بالعلم اللي عندي وبحرص إني أعمل له update بشكل مستمر
والحقيقة إن اللي بيجيلي غالبا بيكون جاي وهو عايز يتغير فعلا وعايز يحافظ على صحته..وكتير منهم بيقولولي:
(أنا جيتلك عشان سمعت إنك مش بتكتبي الحقن)😅
من هنا بتبسط اوي و بعرف ان رحلتنا هتبقى مثمرة و ناجحة بفضل الله
وده في الآخر بيأكدلي إن اللي بيدور على تغيير حقيقي..بيلاقي الطريق
🚨 Serious FDA Warning Issued to Novo Nordisk Over Failures in Reporting Adverse Events for Ozempic, Wegovy, and Related Drugs
The U.S. Food and Drug Administration (FDA) has issued a formal warning letter dated March 5, 2026, to Novo Nordisk, the manufacturer of widely prescribed GLP-1 medications including Ozempic (semaglutide), Wegovy (semaglutide), and Saxenda (liraglutide).
Following inspections conducted in early 2025 at the company's U.S. facility in Plainsboro, New Jersey, the FDA identified serious violations of federal regulations governing post-marketing adverse drug experience (PADE) reporting.
Under U.S. law (21 CFR 314.80 and section 505(k) of the Federal Food, Drug, and Cosmetic Act), pharmaceutical companies are required to promptly investigate and report serious and unexpected adverse events to the FDA within 15 days.
The agency's findings indicate that Novo Nordisk failed to adhere to these requirements, including:
• Not promptly reporting or adequately investigating serious events, such as a disabling stroke in a patient using Saxenda (dismissed without sufficient follow-up based solely on the patient's opinion that it was unrelated).
• Failing to report or investigate a su***de linked to semaglutide use.
• Delaying reporting of suicidal ideation cases until discovered by FDA inspectors.
• Not following up on a patient death associated with semaglutide, citing lack of consent from the reporter—despite regulations not requiring such consent for PADE investigations.
The FDA expressed grave concerns, stating: “Based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio.”
These lapses raise important questions about the integrity of post-marketing safety surveillance for GLP-1 receptor agonists, a class of drugs now used by an estimated 1 in 8 U.S. adults (over 31 million people), according to recent polling data.
With more than 4,000 lawsuits already filed alleging severe side effects—including gastrointestinal issues, vision loss (such as NAION), and other life-altering complications—this development underscores the critical need for robust, transparent reporting systems.
Novo Nordisk has acknowledged receipt of the letter and stated it is taking corrective and preventive actions, planning to address the FDA's requests “expeditiously and holistically.”
The company emphasizes its commitment to regulatory compliance and ongoing dialogue with the agency.
Patient safety depends on reliable adverse event reporting.
Stay informed and advocate for greater transparency in pharmaceutical safety monitoring.
