Local
FDA Orders Blindness Warning on Ozempic, Wegovy and Other GLP-1 Weight-Loss Drugs
The FDA now requires all GLP-1 receptor agonists, including Ozempic, Wegovy, Mounjaro and Zepbound, to carry a label warning about a rare but potentially permanent vision-loss condition called NAION. An Arizona ophthalmologist says the risk is small but real, and urges patients to weigh benefits against dangers with their doctors.
PHOENIX â Federal regulators have ordered a new safety warning on the entire class of GLP-1 weight-loss and diabetes drugs, requiring labels to disclose a potential link to a rare eye condition that can cause sudden, permanent blindness.
The Food and Drug Administration's guidance, issued this week, applies to glucagon-like peptide-1 receptor agonists â a drug family that includes Ozempic, Wegovy, Mounjaro and Zepbound, among the most widely prescribed medications in the country. The labels must now address the potential increased risk of non-arteritic anterior ischemic optic neuropathy, or NAION.
NAION is a rare condition that strikes without warning, causing painless vision loss that in many cases cannot be reversed. Studies have associated it with GLP-1 use, though researchers have not established that the drugs cause the condition.
"I do see patients with NAION and it is a devastating disease. Once you have it, there's no way to reverse it," said Dr. Raj Maturi, a clinical spokesperson for the American Academy of Ophthalmology and an ophthalmologist at Midwest Eye Institute.
The numbers involved are small. Maturi said NAION occurs in roughly four out of every 100,000 people in the general population â about one in 25,000. Among GLP-1 users, that figure rises to about six per 100,000.
"We don't know the exact relationship. All we know is that when people take this medicine, there's a slightly higher risk," Maturi said. "This label already exists in Europe, so the U.S. is finally catching up to that."
The change comes as hundreds of lawsuits have been filed across the country by patients who allege the drugs caused them to lose their sight.
Maturi said the warning is warranted despite the low overall risk.
"It matters to those six people who suddenly went blind in one eye. It changes their life. So it is an important thing to put that down," he said.
He also stressed that the decision to take a GLP-1 should be made between a patient and a physician, weighing the drug's benefits against its dangers. Maturi disclosed that he takes a GLP-1 himself and credited it with helping lower his cholesterol.
NAION "can be significantly debilitating, especially in my work as a surgeon. That would be the end of my career. At the same time, the risk overall is pretty low," he said.
Maturi advised patients to discuss their personal risk profile with their doctor, noting that in some cases stopping the medication may be the best course. He also cautioned against casual use of the drugs for cosmetic weight loss.
"It's important that they look at this as a real drug that's being taken for a significant medical condition, not just, hey, I'd like to lose five pounds before a party," he said.