WHO is alerting health-care professionals and regulatory authorities to the risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the use of semaglutide medicines—Ozempic®, Rybelsus®, and Wegovy®. The European Medicines Agency (EMA) has recommended updating the product information for these medicines to include NAION as a side effect, with a frequency classified as very rare.
Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), is the active ingredient in medications used to treat type 2 diabetes and obesity. NAION is a leading cause of vision loss in adults and the second most common optic neuropathy after glaucoma. It typically presents as sudden, painless, monocular vision loss accompanied by optic disc edema. The vision loss is generally irreversible, and there is currently no effective treatment available. [1]
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature. PRAC concluded that NAION is a very rare side effect of semaglutide, potentially affecting up to 1 in 10,000 users.
Accordingly, EMA has recommended that the product information for semaglutide medicines be updated to reflect this risk. If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay. If NAION is confirmed, treatment with semaglutide should be stopped. [2]
At its May 2025 meeting, the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) also evaluated the evidence and concluded that the Risk Management Plan for semaglutide should be revised to include NAION as a potential risk, including any required additional pharmacovigilance activities.
WHO is issuing this safety alert due to the widespread global use of semaglutide and the serious nature of NAION. Furthermore, WHO has received individual case safety reports (ICSRs) of NAION following semaglutide administration from multiple countries through VigiBase, the global database of reported adverse events of medicinal products.
References
[1] Simonsen E, Lund LC, Ernst MT, et al. Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study. Diabetes Obes Metab. 2025;1‐10. doi:10.1111/dom.16316 ( https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16316 . Accessed 17 June 2025).
[2] EMA. PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy. 6 June 2025 ( https://www.ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy . Accessed 17 June 2025).
