The Food and Drug Administration will require new warnings on GLP-1 medications, including Ozempic, Wegovy, Mounjaro and Zepbound, about a potential increased risk of a rare eye condition that can cause permanent vision loss.
The agency announced the requirement on November 9. Manufacturers must add the risk to the Warnings and Precautions section of labeling across the drug class.
The condition, non-arteritic anterior ischemic optic neuropathy, or NAION, can cause sudden, painless loss of vision in one eye, due to decreased blood flow to the front of the optic nerve,
An FDA analysis of 126 clinical trials found 6.4 cases per 100,000 person-years among GLP-1 users, compared with 3.8 among patients receiving placebo or other diabetes medications. A person-year represents one person followed for one year.
The evidence varied by comparison. A separate FDA study found no statistically significant increase against SGLT-2 inhibitors, but an increase against DPP-4 inhibitors, two other diabetes drug classes.
The FDA urges patients with sudden vision changes to contact a health care professional immediately. Patients who experience NAION should discuss whether to continue treatment with their clinician.
The U.S. action follows a European review focused on semaglutide, the ingredient in Ozempic, Rybelsus and Wegovy. In 2025, the European Medicines Agency’s safety committee concluded that NAION represents a very rare side effect, potentially affecting up to one in 10,000 users.
The European agency recommended adding the condition to product information. Its review covered clinical trials, surveillance reports, and other research. Semaglutide helps regulate blood sugar and appetite, supporting its use for diabetes and obesity.
As The Dallas Express previously reported, researchers have examined several eye complications in GLP-1 users. That coverage addressed earlier research; the new development is the FDA’s labeling requirement.
Provided by Dallas Express
