Rare Vision Loss Risk Confirmed for Wegovy and Ozempic Users by EU Regulators

Highlights

• European Medicines Agency confirms a rare risk of NAION (non-arteritic anterior ischemic optic neuropathy) with Novo Nordisk’s semaglutide.
• Label updates recommended for Wegovy and Ozempic to include this risk.
• Risk observed at a rate of 1 in 10,000 users, higher among type 2 diabetes patients (2 cases per 10,000 patient-years).
• Patients experiencing sudden or worsening vision loss are advised to stop semaglutide and consult a physician.
• Final decision pending approval from the European Commission following EMA’s review and CHMP endorsement.

EMA Links Novo Nordisk’s Semaglutide to Rare Eye Disorder

European health regulators have confirmed that semaglutide, a key ingredient in Novo Nordisk’s drugs Wegovy and Ozempic, poses a rare but serious risk of a vision-threatening condition. The European Medicines Agency (EMA) announced on Friday that semaglutide is associated with non-arteritic anterior ischemic optic neuropathy (NAION), a disorder that may lead to sudden or progressive vision loss.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded the association following a comprehensive review of clinical trial data, post-marketing surveillance, non-clinical studies, and relevant medical literature. As a result, the agency has advised updating the drug’s label to include the risk of NAION, which it classified as “very rare.”

“Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the ‘very rare’ risk of non-arteritic anterior ischemic optic neuropathy.”

Details Behind the Safety Review

The risk assessment stems from two Danish studies released in December 2024, which showed an elevated risk of NAION in patients using semaglutide. These studies prompted the Danish Medicines Agency to initiate a review, followed shortly by the EMA’s own investigation.

NAION, though rare, is the most common cause of sudden optic nerve-related vision loss in older adults. According to EMA findings, the condition was observed in approximately one out of every 10,000 semaglutide users. The committee elaborated that the risk appears to double in patients with type 2 diabetes, with an estimated rate of two NAION cases per 10,000 patient-years of treatment.

“If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay,” the EMA committee said. “If NAION is confirmed, treatment with semaglutide should be stopped.”

Path Toward Regulatory Action

Following the review, PRAC will pass its recommendations to the Committee for Medicinal Products for Human Use (CHMP). From there, the European Commission is expected to make a final, binding decision regarding the label update for semaglutide-containing medications.

Initially marketed as Ozempic for managing type 2 diabetes and later as Wegovy for obesity treatment, semaglutide has been widely adopted across Europe and globally. As of the December 2024 review, 19 confirmed cases of NAION had been reported among semaglutide users, spurring the safety reevaluation.