Europe adds vision-loss risk to Ozempic, Wegovy and Rybelsus labels
European regulators have labeled a rare eye condition a very rare side effect of semaglutide medicines, a change that does not yet apply to U.S. labels.
Europe's drug safety committee has concluded that NAION, an eye condition that can cause loss of vision, is a very rare side effect of semaglutide, and it has recommended updating the product information for Ozempic, Rybelsus and Wegovy [1].
The Pharmacovigilance Risk Assessment Committee (PRAC), which evaluates safety issues for human medicines at the European Medicines Agency, announced the conclusion on 6 June 2025. It reviewed non-clinical studies, clinical trials, post-marketing surveillance and the medical literature. NAION stands for non-arteritic anterior ischemic optic neuropathy [1].
PRAC classified the side effect as "very rare," a category the agency defines as possibly affecting up to 1 in 10,000 people taking the medicine [1]. Results from several large epidemiological studies suggest that adults with type 2 diabetes taking semaglutide have roughly a two-fold higher risk of developing NAION than people not taking the medicine. That corresponds to about one additional case of NAION per 10,000 person-years of treatment, where one person-year means one person taking semaglutide for one year. Data from clinical trials also point to a slightly higher risk in people taking semaglutide compared with placebo [1].
The agency said that patients who experience sudden loss of vision or rapidly worsening eyesight during treatment should contact their doctor without delay, and that treatment with semaglutide should be stopped if NAION is confirmed [1]. How often vision loss from the condition becomes permanent has not been reported, and separate risk estimates for people taking semaglutide for weight loss rather than diabetes have not been reported [1].
The review and the recommended label change cover semaglutide medicines — Ozempic, Rybelsus and Wegovy. No similar conclusion for other GLP-1 medicines has been reported [1]. Semaglutide is also the active ingredient in the oral medicine Rybelsus, which is used for diabetes [1].
Why it matters for patients
This is a change to European product information. Whether the U.S. Food and Drug Administration will make a similar change to U.S. prescribing information has not been disclosed [1].
The risk described is small in absolute terms. The EMA's figure of about one additional case per 10,000 person-years of treatment means that among 10,000 people taking semaglutide for a year, about one extra case of NAION would be expected beyond the cases that would occur anyway [1].
What the regulator highlighted as practical information is symptom recognition: sudden loss of vision or rapidly worsening eyesight during treatment. The EMA's stated instruction is for patients with those symptoms to contact their doctor without delay, and for treatment to stop if NAION is confirmed [1].
The epidemiological findings in the review came from adults with type 2 diabetes. The announcement does not give separate figures for people taking semaglutide for obesity, so whether the same magnitude of added risk applies to that group is not yet known [1].
What happens next
PRAC's recommendations will go to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the agency's opinion [1]. The EMA announcement did not give a date for that step, and it did not say when the European labels themselves would be updated [1].
The news announcement was revised on 13 June 2025 to delete a reference to the European Commission issuing a legally binding decision on the procedure [1].
Sources
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