US FDA orders new eye risk warnings for Ozempic, Zepbound

Nov 9 (Reuters) – The US health regulator on Monday informed patients and healthcare providers of a potential increased risk of a serious eye condition associated with the use ​of GLP-1 drugs for weight loss and diabetes. The US ‌Food and Drug Administration said it is requiring GLP-1 drugs such as Eli Lilly’s Mounjaro and Zepbound, and Novo Nordisk’s Ozempic and Wegovy to add information to the “warnings and precautions” section of labeling about the potential increased ‌risk ​of non-arteritic anterior ischemic optic neuropathy (NAION). The ⁠condition is a common cause ⁠of sudden, painless vision loss, and may lead to permanent impairment of sight in some cases. It is caused by decreased blood flow to the front part of the optic ​nerve, but the underlying cause is not completely understood. The FDA said it has evaluated clinical trial data, animal data, and ⁠post-marketing data, including observational studies and ⁠case reports. Eli Lilly and Novo Nordisk did not ​immediately respond to Reuters’ requests for comment. Last year, the European Medicines ​Agency’s safety committee said Wegovy and Ozempic may in ‌very rare cases cause NAION, the first time a regulator had confirmed the side effect. The condition may affect up to 1 in 10,000 people taking semaglutide, the active ingredient in Wegovy and ⁠Ozempic as well as in Novo’s other diabetes drug Rybelsus, for at least one year, EMA had said. Four patients in Denmark, who experienced ⁠vision loss after using ‌Novo’s GLP-1 drugs, were granted compensation, the ⁠Danish Patient Compensation had said last year. A large ​study ‌published in 2025 tracked nearly 175,000 diabetic patients ​treated with ⁠semaglutide and an equal number taking non-GLP-1 medications. It found that the risk of NAION more than doubled after two years of treatment with a GLP-1 drug, compared to diabetes medicines from other classes. (Reporting by Christy Santhosh and Sneha S K in Bengaluru; Editing ​by Shilpi Majumdar)