FDA orders GLP-1 drug makers to add vision-loss warnings to labels

The U.S. Food and Drug Administration announced on Monday that manufacturers of GLP-1 medications must include warnings about the risk of vision loss. The requirement applies to all currently marketed GLP-1 products, including popular weight-loss drugs such as Ozempic, Wegovy, and Zepbound.

The warning concerns non-arteritic anterior ischemic optic neuropathy, known as NAION and sometimes called an eye stroke. The condition results from reduced blood flow to part of the optic nerve and can cause painless but decreased vision in one eye. There is no known treatment for NAION.

The FDA said its analysis found about six cases of NAION per 100,000 people taking GLP-1 drugs every year, compared with about four cases among those taking a placebo or other diabetes medication. The agency’s review incorporated reports from its Adverse Event Monitoring System and studies involving more than 134,000 patients.

The FDA also cited a May review by the American Academy of Ophthalmology linking semaglutide-based drugs to about a two-fold increase in the relative risk of NAION. A 2024 study of about 16,000 ophthalmology patients found an association between semaglutide and NAION but did not establish a causal relationship.

Novo Nordisk, which makes Ozempic and Wegovy, said the data do not establish a cause-and-effect relationship and that it remains confident in the benefit-risk profile of its GLP-1 medicines. Eli Lilly said it is evaluating the update and will respond to the FDA promptly.

A Northwestern University ophthalmology professor said the absolute risk of developing NAION remains very low and that the overall health benefits of these medications far outweigh the exceedingly low rate of this complication. Numerous lawsuits have alleged that patients suffered NAION and vision loss after using GLP-1s.