The European Medicines Agency (EMA) has issued a safety warning about Novo Nordisk’s popular weight-loss drug Wegovy and its diabetes medications Ozempic and Rybelsus after data suggested they could raise the risk of a rare but serious eye condition.
The EMA’s safety committee found that semaglutide, the active ingredient in all three drugs, is linked to non-arteritic anterior ischaemic optic neuropathy (NAION), a condition that can cause sudden, painless vision loss in one eye by limiting blood flow to the optic nerve. NAION is the second most common cause of optic nerve-related blindness, just behind glaucoma.
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In the past, studies in type-2 diabetes patients have linked Ozempic to NAION, but this is the first time a regulator has formally acknowledged the connection.
According to the EMA, the risk of developing NAION appears to double among users of semaglutide-based medications compared to those taking other drugs. The condition is still considered very rare, potentially affecting up to 1 in 10,000 patients.
The EMA, which launched its review in December with over 3 lakh diabetic patients, has asked Novo Nordisk to include NAION as a very rare side effect in the product information for semaglutide-containing drugs.
Novo Nordisk said it would cooperate with the EMA to update the labels, although its clinical trials and post-market data did not show a clear link between the drugs and the condition. “The benefit-risk profile of semaglutide remains favourable,” the company emphasised in a statement, news agency Reuters reported.
The US Food and Drug Administration has not yet commented on the EMA’s findings.
