WHO Issues Safety Over Rare Eye Disorder from Semaglutide Use

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.

At its May 2025 meeting, the WHO Advisory Committee on Safety of Medicinal Products 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.

Reference: https://www.who.int/news/item/27-06-2025-27-06-2025-semaglutide-medicines-naion