FDA requires NAION warning labels on all GLP-1 medications
The US Food and Drug Administration (FDA) has issued a new warning on GLP-1 medications over a rare eye condition that could lead to sudden and permanent blindness.
On Monday, the FDA announced that it is requiring all GLP-1 medications – including Novo Nordisk’s Ozempic and Wegovy, Eli Lilly’s Mounjaro and Zepbound, as well as Sanofi’s Soliqua – to include information about the potential risk of nonarteritic anterior ischemic optic neuropathy, also known as NAION, on warning labels.
NAION is a rare condition involving sudden reduction of blood flow to the optic nerve, in turn resulting in acute, painless, decreased vision in one eye, including permanent vision loss, the FDA warned.
The FDA began looking at potential links between GLP-1s and NAION after a 2024 study published in the journal JAMA Ophthalmology. The agency proceeded to review 126 clinical trials involving over 134,200 patients and identified 15 probable NAION cases, including 10 among GLP-1 patients, five in patients receiving placebo, and none in patients who were on glucose-lowering medications that were not GLP-1.
The FDA found a NAION incidence rate of 6.4 cases per 100,000 person-years among GLP-1 patients, compared to 3.8 cases among patients on placebo or alternative glucose-lowering medications.
“NAION cases have been reported for all currently marketed GLP-1 RA products,” the FDA said. “FDA concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs.”
“Based on these findings, FDA is requiring that application holders add information about the risk for NAION to the Warnings and Precautions section of labeling of all GLP-1 RAs.”
In response to the FDA announcement, a Novo Nordisk spokesperson told the Guardian that the pharmaceutical company “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.”
The statement also said: “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.”
Eli Lilly said in a statement Monday it was “carefully evaluating the update and will respond to 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.”
Symptoms of the problem include blurred vision, blind spots, distorted colors and other visual disturbances, according to the FDA. Patients experiencing such problems should contact a healthcare professional immediately, the agency said.
