The U.S. Food and Drug Administration says it will add a warning about non-arteritic anterior ischemic optic neuropathy to all GLP-1 drug labels.
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The U.S. Food and Drug Administration announced Monday that the labeling for all GLP-1 drugs will include a warning about a rare eye condition that can lead to significant or permanent vision loss.
The FDA said the risk will be added to the labels of all GLP-1 medications used to treat obesity, diabetes and other medical conditions. The class includes a dozen drugs, such as Zepbound and Mounjaro, and includes both injectable and pill-based therapies.
The eye condition is known as non-arteritic anterior ischemic optic neuropathy. The FDA said it can cause significant vision loss and is associated with decreased blood flow to the optic nerve, while the underlying cause is not understood.
According to the FDA, the problem has been reported with all GLP-1 drugs. The agency began investigating after a 2024 medical paper tied the condition to certain patients taking semaglutide, the active drug in Eli Lilly’s Ozempic.
An FDA analysis of more than 125 clinical trials found the issue occurred in roughly 6 out of every 100,000 patients who took a GLP-1 for at least one year. The comparable rate for people taking a placebo or other glucose-lowering medications was less than 4 per 100,000, the FDA said.
The FDA also said it has received reports through its electronic reporting system for drug injuries and side effects.
Symptoms, the FDA said, can include blurred vision, blind spots, distorted colours and other visual disturbances, and patients experiencing such symptoms should contact a health care professional immediately.
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