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Investing.com -- The European Medicines Agency’s (EMA) safety committee, PRAC, said Friday that it has concluded that Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a rare eye condition that can lead to vision loss, is a "very rare side effect" of semaglutide medicines, including Ozempic, Rybelsus, and Wegovy.
The medications, owned by Novo Nordisk (NYSE:NVO), are widely used for the treatment of diabetes and obesity.
Following a comprehensive review of all available data, including non-clinical studies, clinical trials, post-marketing surveillance, and medical literature, PRAC determined that NAION "may affect up to 1 in 10,000 people taking semaglutide."
The firm explained that several large epidemiological studies indicate that adults with type 2 diabetes taking semaglutide face "an approximately two-fold increase in the risk of developing NAION" compared to those not on the medication.
This is said to translate to about "one additional case of NAION per 10,000 person-years of treatment."
The EMA added that clinical trial data also pointed to a "slightly higher risk" for those on semaglutide versus placebo.
As a result, the EMA said it has recommended updating the product information for semaglutide medicines to include NAION as a "very rare" side effect.
They conclude that patients experiencing "a sudden loss of vision or rapidly worsening eyesight" while on semaglutide are advised to contact their doctor immediately.
If NAION is confirmed, "treatment with semaglutide should be stopped,” states the EMA.