WHO Issues Safety Over Rare Eye Disorder from Semaglutide Use

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. 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.

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.

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.