A European review has concluded the risk of vision loss from semaglutide-containing medicines should be classified as “very rare”.

Semaglutide, a GLP-1 receptor agonist, is the active ingredient in several widely used medicines for the treatment of type 2 diabetes and obesity. Concerns were raised about a potential increased risk of nonarteritic anterior ischemic optic neuropathy (NAION), in people taking the medication.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has conducted 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 one in 10,000 patients.

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 European Union.