EMA Updates Semaglutide Medicine Labels to Include Rare NAION Side Effect

EMA's safety committee has reviewed semaglutide medicines for a possible increased risk of NAION. The committee concluded that NAION is a rare side effect. EMA recommends updating product information for semaglutide medicines to include NAION as a side effect with a frequency of "very rare." Semaglutide is used in diabetes and obesity treatment, and Novo Nordisk is the only US company with FDA-approved semaglutide medicines.

The European Medicines Agency's (EMA) safety committee, PRAC, has concluded that Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a rare eye condition that can lead to vision loss, is a "very rare side effect" of semaglutide medicines, including Ozempic, Rybelsus, and Wegovy [1]. The medications, owned by Novo Nordisk (NYSE:NVO), are widely used for the treatment of diabetes and obesity.

Following a comprehensive review of all available data, including non-clinical studies, clinical trials, post-marketing surveillance, and medical literature, PRAC determined that NAION "may affect up to 1 in 10,000 people taking semaglutide" [1]. The firm explained that several large epidemiological studies indicate that adults with type 2 diabetes taking semaglutide face "an approximately two-fold increase in the risk of developing NAION" compared to those not on the medication [1]. This translates to about "one additional case of NAION per 10,000 person-years of treatment" [1].

Clinical trial data also pointed to a "slightly higher risk" for those on semaglutide versus placebo [1]. As a result, the EMA has recommended updating the product information for semaglutide medicines to include NAION as a "very rare" side effect [1]. Patients experiencing "a sudden loss of vision or rapidly worsening eyesight" while on semaglutide are advised to contact their doctor immediately [1]. If NAION is confirmed, "treatment with semaglutide should be stopped,” states the EMA [1].

The EMA's review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for evaluating safety issues for human medicines [5]. The PRAC's recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course [5].

References:
[1] https://www.investing.com/news/stock-market-news/ema-says-ozempic-wegovy-may-cause-rare-eye-condition-4084765
[2] https://www.newsmax.com/health/health-news/ozempic-wegovy-novo-nordisk/2025/06/06/id/1213864/
[3] https://www.reuters.com/business/healthcare-pharmaceuticals/ozempic-wegovy-may-cause-rare-eye-condition-ema-says-2025-06-06/
[4] https://www.tradingview.com/news/reuters.com,2025:newsml_FWN3S90E0:0-prac-flags-naion-as-very-rare-semaglutide-side-effect/
[5] https://www.ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy
[6] https://ca.finance.yahoo.com/news/ema-says-ozempic-wegovy-may-115806125.html
[7] https://www.politico.eu/article/ozempic-has-very-rare-sight-loss-side-effect-eu-drugs-regulator-finds/