The European Medicines Agency’s (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has completed a safety review of semaglutide-containing medicines following concerns about a possible link to non-arteritic anterior ischemic optic neuropathy (NAION)—a serious eye condition that may result in vision loss.
Semaglutide Linked to Increased NAION Risk
As per the EMA, Semaglutide is the active ingredient in several widely used medicines for diabetes and obesity, including Ozempic, Rybelsus, and Wegovy. After analyzing data from clinical trials, non-clinical research, post-marketing reports, and published studies, PRAC concluded that semaglutide may very rarely cause NAION. The condition could affect up to 1 in 10,000 people taking the drug.
Notably, findings from large-scale epidemiological studies revealed that adults with type 2 diabetes taking semaglutide had nearly double the risk of developing NAION compared to those not using the medication. This equates to approximately one additional case of NAION per 10,000 person-years of treatment. Similarly, clinical trial data indicated a slightly elevated risk for semaglutide users versus those given a placebo.
Updated Safety Guidance and Recommendations
In light of these findings, EMA has recommended updating the product information for semaglutide-based medicines to reflect NAION as a “very rare” side effect. The agency advises patients to seek immediate medical attention if they experience sudden vision loss or a rapid decline in eyesight during treatment. If a diagnosis of NAION is confirmed, doctors should discontinue semaglutide therapy without delay.
How Semaglutide Works
Semaglutide belongs to a class of drugs called GLP-1 receptor agonists. It mimics the action of GLP-1, a natural hormone that boosts insulin secretion in response to food intake. This helps regulate blood sugar levels. Additionally, semaglutide contributes to weight management by enhancing satiety, reducing food intake, and curbing hunger and cravings.
The Safety Review Process
PRAC evaluated the potential link between semaglutide and NAION as part of a post-authorisation safety requirement (also known as LEG), which followed a periodic safety update report (PSUR) assessment. PRAC’s recommendations now move to the Committee for Medicinal Products for Human Use (CHMP), which will issue the EMA’s final opinion on the matter.