Ozempic’s manufacturer was advised to include the serious eye problem as a potential side effect.
The European Medicines Agency (EMA) has determined that medications containing semaglutide, such as Ozempic, Wegovy, and Rybelsus, elevate the risk of a severe eye condition that can result in sudden vision impairment.
Following a thorough safety evaluation, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) announced on Friday that non-arteritic anterior ischemic optic neuropathy (NAION) should be classified as a “very rare” side effect of semaglutide, the primary ingredient in weight-loss and anti-diabetic medications produced by Novo Nordisk.
The EU health watchdog’s review, which began in January 2025, involved analyzing data from clinical trials, post-market surveillance, and medical literature. The findings suggest that adults with type 2 diabetes who take semaglutide face approximately twice the risk of developing NAION compared to those who do not. The “very rare” classification means that the condition may affect up to 1 in 10,000 users.
A recent study also suggested that Ozempic and similar drugs might increase the risk of . However, these medications are reported to decrease the risk of over a dozen other cancers, implying that their overall benefits may still outweigh the risks. Furthermore, the EMA previously investigated reports of suicidal thoughts linked to semaglutide use, although no conclusive causal link was established.
The EMA’s recommendations will now be examined by the Committee for Medicinal Products for Human Use (CHMP) before the European Commission makes a final decision. Novo Nordisk, which lost its position as Europe’s earlier this year, has affirmed its dedication to patient safety and is collaborating with the EMA to update product labels accordingly.
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