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GLP-1 drug safety

FDA requires GLP-1 drug labels to warn of rare eye condition

The Food and Drug Administration is requiring manufacturers to disclose a potential risk of non-arteritic anterior ischemic optic neuropathy, a condition that can cause sudden vision loss and, in severe cases, blindness.

By Ruth Kaplan, Health systems correspondent
. 1-minute read.
Exterior view of the main entrance of FDA Building 1 in Silver Spring, Maryland.
The main entrance of FDA Building 1 at the agency's White Oak campus in Silver Spring, Maryland. Photograph: The U.S. Food and Drug Administration/Wikimedia Commons (public domain)

STAT reported Monday that the Food and Drug Administration is requiring manufacturers to update safety labeling and warn patients and clinicians about a potential risk of non-arteritic anterior ischemic optic neuropathy, or NAION, with glucagon-like peptide-1 (GLP-1) receptor agonists. The agency said the condition is rare but serious and that companies must inform patients and doctors of the risk.

NAION, sometimes called an "eye stroke," occurs when blood flow to the optic nerve is insufficient. It typically causes sudden vision loss, and severe cases can lead to blindness. No proven treatments for the condition currently exist.

The warning covers widely used GLP-1 drugs, including Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound. STAT noted that these medicines have become popular for weight loss and that side effects can emerge in real-world use after a drug reaches large populations, even if they were not seen in clinical trials.

The FDA did not say the drugs cause NAION; it framed the issue as a potential risk.

Ruth KaplanHealth systems correspondent

Ruth Kaplan covers hospitals, health systems and the business of care for Clinical Observer. She writes from published reporting, filings and official statements.

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