The European Medicines Agency (EMA) concluded that non-arteritic anterior ischemic optic neuropathy (NAION), a serious eye condition causing potential vision loss, is a very rare side effect of semaglutide.
Semaglutide, used to treat diabetes and obesity under names including Ozempic, Wegovy, and Rybelsus, will have updated product information to reflect this risk.
A comprehensive review of clinical trials, non-clinical studies, post-marketing surveillance, and medical literature found evidence for up to a twofold increased risk of NAION in people with diabetes taking semaglutide versus those not using the medication.
The estimated incidence is up to 1 in 10,000 people treated with semaglutide, which equates to roughly one additional case per 10,000 person-years of exposure.
EMA recommends that healthcare professionals and patients be aware of this risk, though it remains classified as very rare in frequency, based on current data.135
Sources:
1. https://www.tctmd.com/news/eye-condition-very-rare-side-effect-semaglutide-ema-says
3. https://www.politico.eu/article/ozempic-has-very-rare-sight-loss-side-effect-eu-drugs-regulator-finds/
5. https://www.ainvest.com/news/ema-updates-semaglutide-medicine-labels-include-rare-naion-side-effect-2506/