The European Medicines Agency (EMA) has warned that semaglutide-based drugs—including the widely used Ozempic, Wegovy, and Rybelsus—may cause sudden vision loss due to a rare but serious eye condition.
Following an extensive safety review, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that non-arteritic anterior ischemic optic neuropathy (NAION) should be classified as a “very rare” side effect. NAION is the second leading cause of optic nerve-related blindness after glaucoma.
The warning stems from a review initiated in January 2025, analyzing clinical trial results, post-market surveillance data, and medical literature. Findings show that adults with type 2 diabetes taking semaglutide have about twice the risk of developing NAION compared to those not using the drug.
The EMA advises that patients on semaglutide who experience sudden or rapidly worsening vision seek immediate medical care and stop taking the medication if diagnosed with NAION.
Semaglutide is a GLP-1 receptor agonist developed by Denmark-based Novo Nordisk, used for managing type 2 diabetes and aiding weight loss. The drug works by stimulating insulin production and creating a sensation of fullness.
Novo Nordisk has faced increasing scrutiny over semaglutide’s safety profile. Earlier concerns included a potential link to suicidal thoughts and a newly reported association with increased risk of kidney cancer—though studies also suggest a reduced risk for many other cancers.
In response to the EMA's findings, Novo Nordisk said it remains committed to patient safety and is working with regulators to update warning labels on affected medications.
The EMA’s recommendation will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP), with a final decision expected soon from the European Commission.
Patients are urged not to discontinue treatment without consulting their doctors but should be aware of any visual symptoms while taking semaglutide-based drugs.
Source: Politico (EU)
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