FDA orders new warning on Ozempic, Wegovy, other GLP-1 drugs over rare eye condition
The U.S. Food and Drug Administration announced Monday that it is requiring new warnings on popular diabetes and weight loss drugs, including Ozempic, Wegovy, Mounjaro and Zepbound, over a potential increased risk for a rare eye condition that can cause permanent vision loss.
The condition, called nonarteritic anterior ischemic optic neuropathy, or NAION, occurs when blood flow to the optic nerve is reduced, causing sudden, painless vision loss, typically in one eye. There is currently no known treatment to reverse the vision loss.
There is already an increased risk of the optic nerve condition for people with diabetes and obesity, conditions the medications are prescribed to treat.
In its announcement Monday, the FDA said all GLP-1 medications, including Novo Nordisk's Ozempic and Wegovy, Eli Lilly's Mounjaro and Zepbound, and Sanofi's Soliqua, must include information about the potential risk in their warning labels.
In a statement to ABC News, Novo Nordisk said the available research does not establish that GLP-1 medications cause NAION.
"Novo continues to believe the data do not establish a cause-and-effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines," said Liz Skrbkova, who leads U.S. media and stakeholder relations for Novo Nordisk.
She added, "Patient safety is a top priority for Novo, and we continue to monitor the safety of our medicines, review new research and work with health authorities around the world."
In a separate statement to ABC News, an Eli Lilly spokesperson 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. We are carefully evaluating the update and will respond to FDA promptly."
ABC News has reached out to Sanofi for comment.
The FDA said it began investigating the possible link between GLP-1 drugs and NAION following a 2024 study published in JAMA Ophthalmology that found an increased risk of the condition among patients prescribed semaglutide, the active ingredient in Ozempic and Wegovy.
The agency said the study had limitations but prompted a broader review of clinical trials and other research.
An analysis of 126 clinical trials involving more than 134,000 patients identified 15 probable cases of NAION, including 10 among GLP-1 users and five among placebo recipients.
The FDA found 6.4 cases per 100,000 person-years among GLP-1 users, compared with 3.8 among those receiving a placebo or another diabetes medication.
Other studies examining the possible link between GLP-1 medications and NAION have produced mixed results, with medical experts telling ABC News previously that more research is needed to determine whether the drugs cause the condition.
The FDA said cases have been reported with all currently marketed GLP-1 drugs, although its review of animal data did not identify how the medications might increase the risk.
Symptoms of NAION include sudden vision loss in one eye, blurred vision and blind spots.
The FDA advises patients experiencing these symptoms to contact a health care professional immediately. Patients who develop NAION should also discuss with their doctor whether to continue taking their GLP-1 medication.
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