Regulators say the added risk is small, and every label will now tell patients which signs of sudden vision loss need urgent care.
The FDA is requiring new warnings on Ozempic, Wegovy and other GLP-1 drugs about a rare eye condition that can cause sudden vision loss. (Getty Images)
Diane Wirth went to bed with normal vision. The 66-year-old nurse practitioner from rural Georgia had been taking Wegovy to lose weight, and when she woke the next morning, the sight in her right eye was gone. "I woke up, and the vision was gone," she told NBC News.
Losing her eyesight cost Wirth her job and her independence, she told WSB-TV in Atlanta. She is among hundreds of Americans suing the makers of GLP-1 drugs over vision loss. It has not been established that Wegovy caused her injury.
On Monday, the U.S. Food and Drug Administration ordered new safety warnings for Wegovy, Ozempic, Mounjaro, Zepbound and other GLP-1 medications over the rare eye condition at the center of those lawsuits.
In a safety communication, the agency said manufacturers must add the potential risk of non-arteritic anterior ischemic optic neuropathy, or NAION, to the warnings and precautions section of their labels, a change the companies now must make.
NAION occurs when blood flow to the optic nerve decreases, causing sudden, painless vision loss, usually in one eye. The damage can be permanent, and there is no proven treatment to reverse it.
The condition remains rare. In an FDA analysis of 126 clinical trials involving more than 134,000 patients, researchers counted 6.4 cases for every 100,000 years of GLP-1 treatment, compared with 3.8 among patients on a placebo or other diabetes drugs. That amounts to about 2.6 extra cases for every 100,000 patients treated for one year.
Most GLP-1 drugs are injected under the skin. The FDA now requires their labels to warn of a rare risk of sudden vision loss.
The FDA has not identified how the medications might raise the risk. Many patients who take them also have other NAION risk factors, including diabetes, high blood pressure, sleep apnea and kidney disease.
European regulators acted earlier. In June 2025, the European Medicines Agency listed NAION as a very rare side effect of semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus, estimating it could affect up to one in 10,000 patients.
Novo Nordisk, which makes Ozempic and Wegovy, said it "continues to believe the data do not establish a cause-and-effect relationship," Reuters reported. Eli Lilly, maker of Mounjaro and Zepbound, said it was reviewing the update and would respond to the FDA promptly.
The medications have established benefits for managing blood sugar and weight, and the FDA's action does not remove them from the market.
The agency urges patients to watch for sudden, painless vision loss in one eye, often noticed upon waking. Other warning signs include blind spots, tunnel vision, distorted colors and blurry or hazy central vision.
Anyone with these symptoms should seek medical care right away. Patients taking a GLP-1 should talk with their prescribing clinician before making any change to treatment, Mayo Clinic ophthalmologist Dr. John Chen told ABC News.
For Wirth, the warning comes after the loss of her eyesight. She told WSB-TV she "would've never taken this drug" had she known vision loss was possible.
