The producer of Ozempic was advised to list the serious eye condition as a side effect
The European Medicines Agency (EMA) has concluded that semaglutide-based medications – including Ozempic, Wegovy, and Rybelsus – increase the risk of a serious eye condition that can lead to sudden vision loss.
Following a comprehensive safety review, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) determined that non-arteritic anterior ischemic optic neuropathy (NAION) should be listed as a “very rare” side effect of semaglutide – the main component of weight-loss and anti-diabetic drugs produced by Novo Nordisk.
The EMA’s review, initiated in January 2025, analyzed data from clinical trials, post-marketing surveillance, and medical literature. Findings suggest that adults with type 2 diabetes taking semaglutide have approximately twice the risk of developing NAION compared to those not on the medication.
On Friday, the EU’s health watchdog recommended updating the product information for semaglutide-containing medicines to include NAION as a potential side effect. The “very rare” classification indicates that the condition may affect up to 1 in 10,000 users.
NAION is the second most common cause of optic nerve-related blindness after glaucoma. Patients experiencing sudden vision loss or rapidly worsening eyesight while on semaglutide are advised to seek immediate medical attention and discontinue use if NAION is diagnosed.
The Denmark-based company Novo Nordisk owns the patent on semaglutide, a GLP-1 receptor agonist used for managing type 2 diabetes and obesity. It functions by enhancing insulin secretion and promoting a feeling of fullness, thereby aiding in blood sugar control and weight management.
A recent study also indicated that Ozempic and similar medications may increase the risk of kidney cancer. However, the drugs reportedly lower the risk of more than a dozen other cancers, suggesting their overall benefit may still outweigh the hazards. Additionally, the EMA previously investigated reports of suicidal thoughts associated with semaglutide use, though no definitive causal relationship was established.
The EMA’s recommendations will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP) before a final decision is adopted by the European Commission. Novo Nordisk, which was dethroned as Europe’s most valuable company earlier this year, has stated its commitment to patient safety and is working with the EMA to update product labels accordingly.
