The Food and Drug Administration on Monday said popular GLP-1 weight-loss medications such as Ozempic, Wegovy and others must put a warning about greater risks for permanent vision loss on their packaging.
The federal agency’s requirement also extends to Mounjaro, Zepbound and Soliqua, with the FDA saying the drugs have links to causing nonarteritic anterior ischemic optic neuropathy, or NAION.
The condition reduces blood flow to the optic nerve, causing sudden vision loss in one eye. There is no known treatment to reverse the vision loss.
People were interested in these podcasts
The FDA said it based its decision on clinical trial data, animal data, observational studies and case reports.
For example, more than 120 agency clinical trials involving over 134,000 patients found 15 probable cases of NAION, with 10 of those in GLP-1 users.
The FDA further found 6.4 cases per 100,000 persons among GLP-1 users, as opposed to 3.8 per 100,000 among those receiving a placebo or another diabetes medication.
Eli Lilly, the manufacturer of Mounjaro and Zepbound, said the “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.”
A spokesperson for Novo Nordisk, which makes Ozempic and Wegovy, said, “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.
“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.”
The FDA began looking into the possible link between weight-loss drugs and NAION after a 2024 study said there was an increased risk of the condition among patients who used semaglutide, a key ingredient in Ozempic and Wegovy.
Outside the U.S., European medical regulatory agencies said NAION may affect up to 1 in 10,000 people who use semaglutide.
Please read our comment policy before commenting.