Health authorities have confirmed that Ozempic, Wegovy, and Rybelsus carry a very rare risk of serious eye problems that could lead to vision loss.
The European Medicines Agency’s safety committee has concluded its review into semaglutide-based medicines following concerns about a possible link to non-arteritic anterior ischaemic optic neuropathy (NAION), an eye condition that can cause sudden vision loss.
After examining data from clinical trials, post-marketing surveillance, and medical literature, regulators determined that NAION affects up to 1 in 10,000 people taking semaglutide. Large epidemiological studies suggest adults with type 2 diabetes face approximately double the risk compared to those not taking the medication – equivalent to roughly one additional case per 10,000 person-years of treatment.
The three affected medicines – Ozempic (used for diabetes), Wegovy (for weight management), and Rybelsus (an oral diabetes treatment) – all contain semaglutide, a GLP-1 receptor agonist that helps control blood glucose levels and reduces appetite by mimicking a natural hormone.
Product information for all semaglutide medicines will now be updated to list NAION as a “very rare” side effect. Patients experiencing sudden vision loss or rapidly deteriorating eyesight during treatment must contact their doctor immediately, and if NAION is confirmed, treatment should be discontinued.
This development affects thousands of Irish patients who rely on these medications for diabetes management and weight control. The drugs work by increasing insulin production in response to food whilst reducing hunger and food cravings.
The safety review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which evaluates safety concerns for human medicines. Their recommendations will proceed through the European regulatory process before becoming legally binding across all EU member states.
Despite this rare but serious side effect, the medicines remain available as their benefits continue to outweigh the risks for most patients when used appropriately.