FDA требует предупреждения об опасности для глаз в лекарствах GLP-1 для снижения веса

U.S. Food and Drug Administration announced on Monday that manufacturers of GLP-1 weight-loss drugs, including Ozempic and Zepbound, must add warnings about a rare eye condition called non-arteritic anterior ischemic optic neuropathy (NAION). The agency’s review, which incorporated reports from its Adverse Event Monitoring System and studies covering more than 134,000 patients, found an incidence of about six NAION cases per 100,000 people using GLP-1 drugs annually, compared with four cases among placebo or other diabetes-medicine users.

NAION can cause painless, sudden vision loss in one eye due to reduced blood flow to the optic nerve and has no known treatment. The FDA noted that individuals with a prior history of NAION face a higher risk of recurrence.

The agency’s findings follow a May analysis by the American Academy of Ophthalmology that suggested semaglutide-based GLP-1s, such as Ozempic and Wegovy, may double the relative risk of NAION.

"Patients should contact their health care professional right away if they have any of these symptoms," the FDA advised, listing blurred vision, missing portions of the visual field, color distortion, hazy spots and sudden loss of vision upon waking.

Novo Nordisk, the maker of Ozempic and Zepbound, said patient safety is a top priority but maintained that existing data do not establish a cause-and-effect relationship and that the benefit-risk profile of its GLP-1 medicines remains favorable.

"Novo continues to believe the data do not establish a cause-and-effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines," said Liz Skrbkova, head of U.S. Media and Stakeholder Relations for Novo.

Eli Lilly, another producer of GLP-1 treatments, said it is reviewing the FDA update and will stay in close contact with the agency.

"If anyone is experiencing side effects when taking a Lilly medicine, they should talk to their doctor or other healthcare professional," the company’s spokesperson wrote.

A Gallup poll in July estimated that roughly 28 million Americans are currently using GLP-1 drugs. A 2025 study of 125,000 patients found that about half discontinue the medication within a year, often due to gastrointestinal side effects. The FDA also highlighted additional risk factors for NAION, including smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease.