FDA Requires New Eye-Risk Warnings for GLP-1 Medications
The Food and Drug Administration is requiring new warnings on Ozempic, Wegovy, Mounjaro, Zepbound and other GLP-1 medications about a potential increased risk of a rare eye condition that can cause sudden vision loss.
The condition, nonarteritic anterior ischemic optic neuropathy, or NAION, occurs when insufficient blood flow damages the optic nerve. It differs from diabetic retinopathy, a complication already addressed in several drug labels that affects blood vessels in the retina.
The FDA’s review followed a 2024 study linking semaglutide, the active ingredient in Ozempic and Wegovy, with higher NAION rates. Researchers said further investigation was needed to establish whether the drug causes the condition.
Across 126 clinical trials, the agency identified approximately six cases per 100,000 people taking GLP-1 medications for one year, compared with four among those receiving placebo or another diabetes treatment. Cases were reported across the drug class, prompting broader warnings. Real-world findings varied depending on the comparison treatment.
Interpreting the evidence remains difficult because many GLP-1 users have other NAION risk factors, including diabetes, high blood pressure, sleep apnea and kidney disease. Smoking and previous NAION also increase risk.
Symptoms include sudden, painless vision loss in one eye, blind spots, tunnel vision, distorted colors and central blurriness. The FDA advises affected patients to contact a healthcare professional immediately and not stop medication without consulting their provider. Suspected cases should receive prompt ophthalmology evaluation. No treatment has been proven to reverse NAION-related vision loss.
Regulators in the European Union, United Kingdom and Australia have introduced similar warnings, primarily for semaglutide. The FDA maintains that GLP-1 medications’ benefits continue to outweigh their risks when used as directed. Depending on the medication, approved uses include diabetes management, weight management and reducing certain cardiovascular or kidney risks. Treatment decisions should consider each patient’s health conditions and individual circumstances.