The Food and Drug Administration announced Monday that it is requiring manufacturers of GLP-1 medications to warn that they can increase the risk of vision loss.
The warning applies to all GLP-1 medications, including popular weight loss drugs like Ozempic and Wegovy.
GLP-1s can lead to cases of non-arteritic anterior ischemic optic neuropathy (NAION), a very rare condition where a lack of blood flow to the optic nerve causes decreased vision or vision loss in an eye, the agency said.
There is no known treatment for NAION, which is also associated with diabetes, smoking and high blood pressure.
Studies have reached conflicting conclusions about whether GLP-1 drugs raise the risk of NAION, often referred to as “eye stroke,” but lawsuits and some findings have raised concerns about side effects the drugs may carry.
The FDA cited a 2024 study of about 16,000 ophthalmology patients that found an association between semaglutide — synthetic versions of the body’s naturally occurring GLP-1 that regulate blood sugar and signal fullness — and NAION but did not establish a causal relationship between the two.
Numerous lawsuits have alleged that patients suffered NAION and vision loss after using GLP-1s. The FDA said in its announcement that it reviewed clinical trial data, observational studies and case reports to make its conclusion.
NAION cases have been reported for all currently marketed GLP-1 products, the FDA said.
Eli Lilly, which manufactures weight loss drugs, said in a statement that it is evaluating the update and will respond to the FDA promptly.
“Patient safety is Lilly’s top priority,” the company said. “FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines.”
Novo Nordisk and Sanofi, which also manufacture FDA-approved GLP-1 medications, did not immediately respond to a request for comment Monday afternoon.
Novo Nordisk said in a statement to The Washington Post before Monday’s announcement that personal injury lawsuits against the company are “without merit” and that a 2026 study of over 90,000 participants in clinical trials for the company’s GLP-1 products found no association between the drugs and NAION.
“Considering the totality of evidence from clinical trials, post-marketing reports and observational studies, alongside the generally low incidence rate of NAION, Novo believes that the benefit-risk profile of semaglutide remains favorable,” Novo Nordisk spokesperson Liz Skrbkova said.
Patients should contact their doctors immediately if they experience symptoms of NAION and discuss whether to continue taking GLP-1s or stop, the FDA said.
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