Click it and Unblock the Notifications
GLP-1 drugs warning: FDA adds rare vision loss risk to Ozempic and Wegovy labels
US Food and Drug Administration regulators will add a new warning to GLP-1 drug labelling, including Ozempic and Wegovy, about a rare eye condition linked to vision loss. The agency cited reports across the class and a review of more than 125 clinical trials, with a low long-term incidence.
Popular weight loss medicines such as Ozempic and Wegovy are set to carry a new US warning. Regulators said the update covered a rare eye problem that can sometimes cause permanent vision loss. The Food and Drug Administration said it would add the risk to labels for all GLP-1 drugs used for obesity and diabetes.
/img/2026/11/fda-adds-glp-1-drug-warning-on-rare-vision-loss-risk-1794331822059-600x338.jpg "FDA warns of rare vision loss")
The warning applied to a large group of injectable and pill medicines. The FDA said the class included about a dozen GLP-1 drugs. Brands named by the agency included Zepbound and Mounjaro. Officials said the side effect had been reported across the GLP-1 class, not only for one product.
GLP-1 drugs warning focuses on rare optic nerve condition
The FDA linked the warning to a condition called non-arteritic anterior ischemic optic neuropathy. The agency said the condition could lead to major vision loss. It happened when blood flow to the optic nerve dropped. The FDA said the exact cause behind the drop in blood flow was unclear.
FDA scientists began reviewing the issue after a 2024 medical paper. The paper associated the condition with some patients taking semaglutide. Semaglutide is the active drug in Novo Nordisk’s Ozempic. The agency said this publication helped prompt a broader review of GLP-1 medicines.
GLP-1 drugs warning backed by FDA review of clinical trials
In its review, the FDA analysed results from more than 125 clinical trials. The agency said roughly 6 in every 100,000 patients had the condition. Those patients took a GLP-1 for at least one year. The FDA compared this with people taking placebo or other glucose-lowering medicines.
The FDA said the comparable rate for placebo or other glucose-lowering drugs was below 4 per 100,000. Officials also pointed to case reports outside trials. The agency said it found reports in its electronic tracking system. That system collects reports of drug injuries and suspected side effects.
GLP-1 drugs warning includes symptoms patients should watch for
The FDA listed several symptoms linked to the eye condition. Signs included blurred vision, blind spots, and distorted colours. The agency also mentioned other visual disturbances. The FDA said patients who notice such changes should contact a health care professional immediately.
The FDA said the label change covered blockbuster GLP-1 medicines for obesity, diabetes, and other conditions. Officials described the risk as rare but important to note. The agency said reports had appeared with all GLP-1 drugs. The warning aimed to ensure patients and clinicians had updated safety information.
With inputs from PTI
Sign in with Google