EMA Review Finds Rare Risk of Vision Loss Associated With Semaglutide Medicines

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines following concerns about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), according to an alert posted on the EMA website. 

Semaglutide, a GLP-1 receptor agonist, is the active ingredient in several widely used medicines for the treatment of type 2 diabetes and obesity, including Ozempic, Rybelsus, and Wegovy.

After a comprehensive review of available evidence—including data from nonclinical studies, clinical trials, post-marketing surveillance, and published medical literature—the PRAC has determined that NAION should be classified as a very rare side effect of semaglutide use, meaning it may affect up to 1 in 10,000 patients.

The committee’s review found that several large epidemiological studies indicate semaglutide use in adults with type 2 diabetes is linked to roughly a twofold increased risk of developing NAION compared to individuals not using the medicine. This translates to approximately one additional case of NAION per 10,000 person-years of treatment. Data from clinical trials also suggested a slightly elevated risk of NAION in patients taking semaglutide versus those taking placebo.

As a result, the EMA is recommending that product information for semaglutide-containing medicines be updated to reflect NAION as a very rare side effect. 

The PRAC’s recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which is responsible for assessing the overall benefit-risk profile of medicines in the EU. The CHMP will adopt a formal opinion, which will then be forwarded to the European Commission for a legally binding decision applicable across all EU Member States.