Eye Condition a ‘Very Rare’ Side Effect of Semaglutide, EMA Says

Nonarteritic anterior ischemic optic neuropathy (NAION), which can lead to vision loss, is a “very rare” side effect of treatment with the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, the safety committee of the European Medicines Agency (EMA) has concluded.

The agency’s pharmacovigilance risk assessment committee (PRAC) determined that up to one out of every 10,000 people taking semaglutide—sold under trade names Ozempic, Rybelsus, and Wegovy (Novo Nordisk) for the treatment of diabetes and obesity—may be affected by NAION. The eye condition is caused by a reduction in blood flow to the optic nerve, eventually resulting in nerve damage and possibly blindness.

The EMA has recommended updating semaglutide’s labeling to reflect this information. “If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay,” the agency said in its Friday announcement. “If NAION is confirmed, treatment with semaglutide should be stopped.”

In January, the agency said it would start looking into the issue after some—but not all—studies indicated that there was an association between semaglutide treatment and NAION. The PRAC reviewed data from nonclinical studies, clinical trials, postmarketing surveillance databases, and the medical literature, finding that in large epidemiological studies of adults with type 2 diabetes, semaglutide users had about double the risk of the eye condition compared with nonusers. Clinical trials also indicated a “slightly higher” risk of the condition with the GLP-1 drug versus placebo.