FDA Requires Vision-Risk Warnings Across the GLP-1 Drug Class

The U.S. Food and Drug Administration on Nov. 9 required makers of GLP-1 drugs to warn that treatment may raise the risk of a rare condition that can cause sudden vision loss.

The condition, nonarteritic anterior ischemic optic neuropathy, or NAION, affects the optic nerve. The FDA listed Wegovy and Zepbound among the medicines covered by the change, which places the warning in the labels’ Warnings and Precautions section.

The FDA reviewed 126 randomized trials involving 134,253 people and identified 15 probable NAION cases: 10 among GLP-1 users and five among placebo recipients. The estimated rates were 6.4 cases per 100,000 person-years for GLP-1 users and 3.8 for the combined comparison group. The warning describes a potential risk; the review did not provide product-specific risk estimates.

In a separate study of adults with type 2 diabetes who started treatment between 2019 and 2024, NAION risk was higher for GLP-1 drugs than for DPP-4 inhibitors. The comparison with SGLT-2 inhibitors showed no statistically significant increase.

The FDA’s action covers the broader GLP-1 class. In June 2025, Europe’s medicines regulator classified NAION as a very rare side effect of semaglutide.