EMA adds sudden vision loss to European semaglutide labels

The European Medicines Agency's safety committee has concluded that non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that can cause vision loss, is a "very rare" side effect of semaglutide, the active ingredient in Ozempic, Rybelsus and Wegovy ^[1]. The Pharmacovigilance Risk Assessment Committee (PRAC) announced the conclusion on June 6, 2025 and recommended that the product information for all three medicines be updated to list NAION ^[1].

In EU labeling terms, "very rare" means the event may affect up to 1 in 10,000 people taking the medicine ^[1].

What the review looked at

PRAC said it reviewed all available data on NAION and semaglutide, including non-clinical studies, clinical trials, post-marketing surveillance reports and published medical literature ^[1]. The committee reported that results from several large epidemiological studies suggest that semaglutide exposure in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing NAION compared with people not taking the medicine ^[1].

That relative number translates into a small absolute one. According to PRAC, the doubled risk corresponds to roughly one additional case of NAION per 10,000 person-years of treatment ^[1]. The agency explained that one person-year means one person taking semaglutide for one year ^[1]. Data from clinical trials also pointed to a slightly higher risk of the condition among people taking semaglutide compared with people taking placebo ^[1].

Along with the labeling change, EMA said that if patients experience a sudden loss of vision or rapidly worsening eyesight during semaglutide treatment, they should contact their doctor without delay, and that if NAION is confirmed, treatment with semaglutide should be stopped ^[1].

How the decision was made

The potential link between semaglutide and NAION was evaluated as a post-authorization measure that came out of a periodic safety update report assessment, rather than as a full emergency safety referral ^[1]. PRAC is the EMA committee responsible for evaluating safety issues for human medicines ^[1].

The recommendations go next to EMA's Committee for Medicinal Products for Human Use (CHMP), which adopts the agency's formal opinion ^[1]. EMA revised its own announcement on June 13, 2025 to delete a reference to the European Commission issuing a legally binding decision on the procedure ^[1].

Why it matters for patients

This is a European regulatory action covering European product information for Ozempic, Rybelsus and Wegovy ^[1]. The sources here do not address what US labeling says or whether the Food and Drug Administration has taken a parallel step, so that is not known from this material.

Still, the underlying evidence is the same worldwide, and the numbers give US patients a way to size the risk. A two-fold increase sounds alarming on its own, but NAION is uncommon to begin with, and PRAC put the added burden at about one extra case for every 10,000 years of patient treatment ^[1]. Put another way, the label frequency category assigned is the lowest one EMA uses: up to 1 in 10,000 people ^[1].

The epidemiological evidence PRAC cited came from adults with type 2 diabetes ^[1]. The EMA announcement does not break out a separate risk estimate for people using semaglutide for obesity under the Wegovy brand, though the labeling recommendation applies to Wegovy as well as Ozempic and Rybelsus ^[1].

The practical takeaway in the EMA notice is about recognition and timing: sudden vision loss or rapidly worsening eyesight is the symptom pattern regulators flagged, and they said it warrants prompt contact with a doctor ^[1]. The agency also stated that confirmed NAION should lead to stopping semaglutide ^[1]. Decisions about any individual's treatment belong to that person and their clinician.

What happens next

PRAC issued its conclusion on June 6, 2025, following its meeting held June 2–5, 2025 ^[1]. The recommendations then move to CHMP for adoption of the agency's opinion ^[1]. EMA's announcement does not give a date for when updated package leaflets will reach patients in Europe, and it does not address timing for any changes outside the EU.