EMA links Novo Nordisk’s Ozempic and Wegovy to rare optic nerve damage causing sudden vision loss; semaglutide risk under global review.
European Regulator Flags Vision Risk in Semaglutide Drugs
The European Medicines Agency (EMA) has concluded that Novo Nordisk’s popular weight-loss drug Wegovy and type 2 diabetes treatments Ozempic and Rybelsus may be linked to a rare but serious eye disorder known as non-arteritic anterior ischemic optic neuropathy (NAION).
This marks the first time a regulatory authority has officially recognized a connection between semaglutide — the active ingredient in these drugs — and NAION, a condition that can cause sudden, painless vision loss in one eye.
Rare Disorder, Significant Impact
NAION occurs when blood flow to the optic nerve is reduced, resulting in damage that can lead to permanent blindness. While the EMA estimates the risk at up to 1 in 10,000 users, it noted that patients on semaglutide were twice as likely to develop the condition compared to those not on the drug.
This conclusion follows an EMA review that began in December 2024, prompted by emerging clinical data and post-market safety reports.
Evidence Behind the Decision
The EMA analyzed data from nearly 350,000 diabetic patients, alongside clinical trial results, non-clinical data, and real-world surveillance. Findings consistently indicated an elevated risk of NAION with long-term semaglutide use, particularly compared to users of other diabetes medication classes.
Semaglutide is part of the GLP-1 receptor agonist drug class, known for its effectiveness in regulating blood sugar and promoting weight loss by inducing satiety.
Label Change and Regulatory Actions
As a result of the findings, the EMA has requested that Novo Nordisk update product labeling to list NAION as a potential side effect, categorized as “very rare.” Physicians are being advised to monitor patients for early symptoms of visual changes, particularly those with preexisting eye conditions.
The U.S. Food and Drug Administration (FDA) has not yet commented on the EMA’s findings, but pressure may build for a similar review in North America.
Global Implications Amid Soaring Demand
The safety alert comes at a time when global demand for semaglutide-based drugs is surging, driven by interest in both weight-loss and metabolic treatments. While the absolute risk remains low, regulators emphasize the importance of informed prescribing and vigilant monitoring.
Patients currently taking Ozempic, Wegovy, or Rybelsus are advised not to discontinue their medication without medical consultation, but to report any sudden changes in vision promptly.
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