FDA issues new warning for Ozempic saying it can cause blindness with ‘eye stroke’ side effect

(Daily Mail) In a statement to the Daily Mail, Eli LIlly – which manufactures Mounjaro and Zepbound – said: ‘Patient safety is Lilly’s top priority.

‘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.

‘As always, we will remain in close contact with the agency and continue to review all available data, including any data regarding 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 respond to a request for comment.

In the US, an estimated 15 percent of adults, equivalent to about 40 million people, have used a weight loss drug.

It is not clear how common NAION is for those taking the medications.

Last year, the European Medicines Agency’s safety committee said NAION may affect up to one in 10,000 people taking semaglutide, the active ingredient in ​Wegovy and Ozempic as ​well as in ⁠Novo’s other diabetes drug Rybelsus, for at least one year.

Four patients in Denmark, who experienced vision loss after using ​Novo’s GLP-1 ⁠drugs, were granted compensation, the Danish Patient Compensation had said last year.

NAION affects around 6,000 to 27,000 Americans aged 50 years and over each year. Older adults, smokers and those suffering from diabetes are thought to be at higher risk of suffering from the condition.

Symptoms include sudden, painless vision loss in one eye that patients may notice upon waking, blurred or missing portions of vision, distortion of colors, and reduced central sharpness, per the FDA.

The agency urges patients to contact their health care professional right away if they have any of these symptoms.

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

In an accompanying comment on the 2025 study, scientists wrote that the results could ‘theoretically be linked to rapid improvement in glycemia,’ which is the term for 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.’

One individual suing Novo Nordisk over the condition, 53-year-old Michelle Fennell, told the Wall Street Journal that she began experiencing blurred vision around six months after she started using Ozempic.

At the time, she was using the injection for her type 2 diabetes.

What are the warning signs of NAION?
Most people with NAION experience a sudden change in vision.

Because the condition is usually painless, it can be easy to miss the early signs.

Symptoms often include a blurred, dim or dark patch in one eye.

Source: NHS

Fennell said her right eye began to feel heavy and her peripheral vision suddenly weakened. Her doctor diagnosed NAION two weeks later.

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

Another claimant, Jay Vandegriff, was also taking Ozempic for type 2 diabetes, having been prescribed the jab in 2023.

Around a year later, the now 69-year-old began noticing changes to his vision, which he thought were a smudge on his glasses.

After cleaning them, however, he realized the problem was with his eyes.

Soon after, he was diagnosed with NAION, which he says has taken two-thirds of the sight in 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.’

Separately, several more claims have been lodged against Eli Lilly, the makers of Mounjaro, but these are said to be far fewe