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The European Medicines Agency's Safety Board concluded that Novo Nordisk's common weight loss drug Wegovy and treatment for type 2 diabetes could lead to a rare outbreak of potentially dangerous ocular conditions.
When called non-arterial anterior ischemic optic neuropathy (NAION), this condition can affect one in 10,000 people taking semaglutide.
The EMA, which began its review in December, said that drug use is associated with approximately twice the risk of developing a condition compared to people who are not taking the drug.
Nion develops into the optic nerve due to insufficient blood flow, causing sudden, painless vision loss in one eye. It is the second most common cause of blindness due to optical nerve damage following glaucoma.
Research has previously linked semaglutide to naion. However, this is the first time a regulator has created a link.
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Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists and functions by controlling blood glucose levels and causing satiety.
A large study of nearly 350,000 diabetic patients, published earlier this year, showed that they were more than twice as likely to develop Naion after long term use of semaglutide compared to patients taking medication from other classes.
EMA said it reviewed all available data on Naion using Semaglutide, including data from non-clinical studies, clinical trials and post-market surveillance.
We are recommending pharmaceutical companies to update prescription information for drugs, including Semaglutide, to include Naion as a “very rare” side effect.
The U.S. Food and Drug Administration did not immediately respond to Reuters' request for comment.
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