Attention Healthcare professionals: WHO Issues Safety Alert on Semaglutide Use

Geneva: The World Health Organization (WHO) has issued a global safety alert highlighting the risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the use of semaglutide-containing medicines, including Ozempic®, Rybelsus®, and Wegovy®. These widely prescribed drugs are used for the management of type 2 diabetes and obesity.

"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," stated the alert

The alert follows a recent review by the European Medicines Agency (EMA), which recommended updating product information for these medicines to include NAION as a very rare side effect. 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.

In parallel, the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP), during its May 2025 meeting, recommended revising the Risk Management Plan for semaglutide to include NAION and any necessary pharmacovigilance measures.

The WHO noted that it has received individual case safety reports (ICSRs) of NAION following semaglutide administration from multiple countries through VigiBase, the global adverse event database.

Healthcare professionals should advise patients on the early signs of NAION and to discontinue semaglutide immediately if the condition is suspected. Patients are advised to seek urgent medical attention in case of sudden or rapidly worsening vision during treatment.