The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines, confirming a potential link between the drug and a rare eye condition known as non-arteritic anterior ischemic optic neuropathy (NAION). The findings, published by the EMA, indicate that NAION should now be listed as a “very rare” side effect in the product information for semaglutide-based treatments such as Ozempic, Rybelsus, and Wegovy.
Semaglutide is a GLP-1 receptor agonist widely prescribed for type 2 diabetes and obesity. It mimics the action of a natural hormone to stimulate insulin production, regulate blood sugar, and reduce appetite. However, concerns about vision loss led the EMA to investigate the drug’s safety profile more closely.
The PRAC conducted a thorough evaluation of all available data, including non-clinical studies, clinical trials, post-marketing surveillance, and findings from published medical literature. According to the committee, “NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide).”
Epidemiological studies showed that adults with type 2 diabetes treated with semaglutide had about a two-fold increased risk of developing NAION compared to those not on the drug. Clinical trials also reported a slightly elevated risk in patients taking semaglutide versus placebo.
The EMA now advises that patients using semaglutide who experience sudden vision loss or rapidly declining eyesight should contact a healthcare provider immediately. “If NAION is confirmed, treatment with semaglutide should be stopped,” the PRAC stated.
The PRAC’s recommendations will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), followed by a final legally binding decision from the European Commission, applicable across all EU member states.
While semaglutide remains an effective treatment for diabetes and obesity, these new findings highlight the importance of ongoing pharmacovigilance to safeguard patient health.
Reference: https://www.ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy
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