FDA GLP-1 Warning Adds Rare Vision Risk to Drug Labels
The FDA is requiring makers of several GLP-1 medicines to add a warning about a potential increased risk of a rare eye condition that can cause sudden vision loss. The change covers drugs used for weight loss and diabetes, including Mounjaro, Zepbound, Ozempic and Wegovy.
The US Food and Drug Administration (FDA) is requiring makers of several GLP-1 drugs to warn about a potential increased risk of a rare eye condition, the agency said Monday. The fda orders warning glp-1 change applies to medicines used for weight loss and diabetes.
The labeling update covers Eli Lilly’s Mounjaro and Zepbound, and Novo Nordisk’s Ozempic and Wegovy. The drugs must add information about non-arteritic anterior ischemic optic neuropathy, or NAION, to their “warnings and precautions” sections.
Condition can cause sudden vision loss
NAION is a common cause of sudden, painless vision loss. It can permanently impair sight in some cases.
The condition results from reduced blood flow to the front of the optic nerve, although its underlying cause is not completely understood. The FDA said it reviewed clinical-trial data, animal data and post-marketing information, including observational studies and case reports.
The agency’s communication applies to all medicines with GLP-1 receptor agonist activity, not just the named products. Lilly said it was evaluating the update and would respond to the FDA.
“FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines,” a Lilly spokesperson said.
Companies weigh in on evidence
Novo Nordisk said the available data do not establish that the drugs cause the eye condition. “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,” a company spokesperson said.
Earlier evidence has also raised questions about the possible risk. The European Medicines Agency’s safety committee said last year that NAION may affect up to 1 in 10,000 people taking semaglutide for at least one year. Semaglutide is the active ingredient in Wegovy and Ozempic, as well as Novo’s diabetes drug Rybelsus.
A study published in 2025 tracked nearly 175,000 patients with diabetes taking semaglutide and an equal number taking medicines outside the GLP-1 class. It found that the risk of NAION more than doubled after two years of treatment with a GLP-1 drug compared with other diabetes medicines.
Four patients in Denmark who experienced vision loss after using Novo’s GLP-1 drugs were granted compensation, the Danish Patient Compensation said last year.
