Non-arteritic anterior ischemic optic neuropathy, or NAION, is a very rare eye condition that causes vision loss; it affects 1 in 10,000 patients taking Semaglutide for treatment of type 2 diabetic patients or obese patients trying to lose weight.
EMA’s safety committee (PRAC) after doing some post marketing surveillance & looking into recent studies found out that patients taking medications containing Semaglutide has a two-fold increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION) compared to individuals not using these medicines. These medications include (Ozempic, Rybelsus and Wegovy)
Therefore, EMA recommends updating Semaglutide product information to include NAION as a very rare side effect. Patients experiencing sudden vision loss or rapid eyesight deterioration should seek medical attention immediately. If NAION is diagnosed, Semaglutide treatment must be discontinued.
The potential link between Semaglutide and NAION was assessed as part of a post-authorization safety review following a PSUR evaluation. The Pharmacovigilance Risk Assessment Committee (PRAC) conducted the review and issued recommendations, which will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for final adoption of the EMA’s opinion.