FDA Orders Vision-Loss Warning on Ozempic, Zepbound and All GLP-1 Drugs

The Food and Drug Administration said Monday that all GLP-1 drugs must carry a new label warning about a rare eye condition that can cause sudden and often permanent vision loss. The requirement covers Ozempic, Wegovy, Mounjaro and Zepbound, as well as several older GLP-1 diabetes medicines, NBC News reported.

The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION. Doctors quoted by NBC News and CBS News stressed that it is rare and that patients should not panic or abruptly stop treatment, but should seek care quickly if their vision changes.

What the FDA is requiring and why

NAION occurs when blood flow to the optic nerve is reduced or blocked. The nerve carries signals from the eye to the brain. According to the FDA, the result can be sudden, painless vision loss in one eye. NBC News reported that the damage is permanent and there is no known treatment.

The agency said patients and caregivers should know about a potential increased risk of the condition with GLP-1 use. CBS News reported that the class includes a dozen injectable or pill-based drugs, which are used for obesity, diabetes and several other conditions.

FDA scientists began looking into the issue after a 2024 paper tied NAION to certain patients taking semaglutide, the active ingredient in Ozempic and Wegovy, CBS News reported. NBC News said that study, published in JAMA Ophthalmology, found diabetes patients prescribed semaglutide were four times as likely to develop NAION as those who were not.

What the data show, and what remains unknown

The FDA said it reviewed reports in its adverse event system and data from multiple clinical trials. Cases have been reported with every GLP-1 drug now on the market. The Daily Mail reported that the agency also looked at animal data.

According to CBS News, an FDA analysis of more than 125 clinical trials found the problem in roughly 6 of every 100,000 patients who took a GLP-1 drug for at least one year. For people on a placebo or other glucose-lowering drugs, the rate was less than 4 per 100,000.

FDA scientists could not identify a mechanism by which the drugs might raise the risk, NBC News reported. Risk factors for NAION overlap with conditions common among GLP-1 users, including Type 2 diabetes, obesity, sleep apnea and hypertension.

Estimates of how common NAION is vary by source. NBC News, citing the American Academy of Ophthalmology, said it affects up to 10 out of 100,000 people over age 50. CBS News, citing the same group, gave a range of 2 to 10 per 100,000 adults over 50. The Daily Mail reported that it is unclear how common the condition is among people taking the drugs.

Studies have also reached different conclusions about the size of the increase. The Daily Mail cited a 2025 analysis in JAMA Network Open that found semaglutide and tirzepatide users were 76 percent more likely to develop NAION than people on other diabetes medicines, though the researchers said the overall risk was low.

How the drugmakers responded

Novo Nordisk, which makes Ozempic and Wegovy, told CBS News it still believes the data do not establish cause and effect and that it is confident in the benefit-risk profile of its GLP-1 medicines. It added that it recognizes NAION can profoundly affect patients and families.

Eli Lilly, which makes Mounjaro and Zepbound, said it is evaluating the update and will respond to the FDA promptly. The company noted that the FDA notice applies to all GLP-1 medicines and does not cite findings specific to Lilly products.

The Daily Mail reported, citing unspecified reports, that nearly 100 lawsuits have been filed against Novo Nordisk over the condition since 2025. It said a smaller number of claims have been lodged against Lilly.

Why it matters for people taking GLP-1 drugs

The Daily Mail reported that an estimated 15 percent of U.S. adults, about 40 million people, have used a weight loss drug, so even a rare side effect touches a large population.

The FDA listed the symptoms to watch for: blurred vision, blind spots, distorted colors and reduced central sharpness. The Daily Mail added that people may notice sudden loss of vision in one eye on waking. The agency said anyone with these symptoms should contact a health care professional right away.

Dr. Manjot Gill, an ophthalmologist at Northwestern Medicine in Chicago, told NBC News the warning is appropriate and mainly serves public awareness. She said patients should not become overly anxious or stop their medications, but should see an eye provider if their vision changes.

Dr. Joseph Rizzo, a neuro-ophthalmologist who co-authored the 2024 paper, told CBS News he believes the evidence shows GLP-1 use raises the risk. He said he does not discourage patients from using the drugs, adding that they have been "profoundly beneficial to a large number of people." He also said vision loss from NAION tends to be irreversible, can worsen even after a patient stops the drug, and can differ between the two eyes.

The new language joins existing warnings on the Novo Nordisk and Lilly labels, which already cover pancreatitis, gallbladder problems and kidney injury. They also carry the FDA's strongest warning, a black box, for a possible risk of thyroid tumors, according to NBC News.

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Around Prague, based on reporting by Daily Mail, NBC News, CBS News