FDA adds vision loss warning to GLP-1 drug labels
Regulators found a rare optic nerve condition in 6 of every 100,000 patients taking the medications for a year.
By Ella Cox ·
The Food and Drug Administration announced Monday that all GLP-1 medications will carry a new warning about a rare eye condition that can lead to permanent vision loss. The label change affects the class of drugs used to treat obesity, diabetes, and other conditions, including popular brands like Ozempic, Wegovy, Zepbound, and Mounjaro.
The condition is called non-arteritic anterior ischemic optic neuropathy. It results from reduced blood flow to the optic nerve. The FDA noted that while the exact cause remains unclear, the risk has been reported with every drug in this category.
Regulators began investigating the link after a 2024 medical paper associated the eye problem with semaglutide. That is the active ingredient in Eli Lilly’s Ozempic. The FDA then reviewed data from more than 125 clinical trials to gauge the scale of the risk.
The analysis showed that the condition occurred in approximately 6 out of every 100,000 patients who used a GLP-1 drug for at least one year. In comparison, the rate was under 4 out of every 100,000 for people taking placebo or other glucose-lowering treatments. The agency also identified additional cases in its electronic reporting system for drug injuries and side effects.
The FDA listed blurred vision, blind spots, distorted colors, and other visual disturbances as key symptoms. The agency advised patients experiencing these issues to contact a health care professional immediately.
