WASHINGTON, Nov. 10 (TodayViralUSA) — The Food and Drug Administration is requiring every GLP-1 drug on the U.S. market, including Ozempic, Wegovy, Mounjaro and Zepbound, to carry a new warning about a rare eye condition that can cause sudden and sometimes permanent loss of vision.
In a drug safety communication issued Monday, the agency said makers of all GLP-1 receptor agonists must add information about a potential increased risk of non-arteritic anterior ischemic optic neuropathy, or NAION, to the “Warnings and Precautions” section of their labels.
What the data show
The FDA said its decision followed a review of animal studies, clinical trials, adverse event reports, observational research and its own real-world data. A meta-analysis of 126 randomized trials found 6.4 NAION cases per 100,000 person-years among patients taking GLP-1 drugs, compared with 3.8 cases among those on a placebo or another glucose-lowering drug.
The agency stressed that NAION remains rare, and CNBC reported that a causal link has not been established. Cases have been reported for every currently marketed GLP-1 product, the FDA said.
Similar warnings already appear on semaglutide labels in Europe, the United Kingdom and Australia, USA Today reported. A 2024 study in JAMA Ophthalmology helped prompt the U.S. review.
Symptoms patients should watch for
NAION is caused by reduced blood flow to the front of the optic nerve. According to the FDA, warning signs include:
- Sudden, painless vision loss in one eye, often noticed on waking
- Blurred or missing areas of vision, such as blind spots or tunnel vision
- Distorted colors or reduced central sharpness
Patients who notice these symptoms should contact a health care professional right away, the agency said. Anyone who has had a NAION event should discuss with their doctor whether to continue the medication. The FDA advised clinicians to refer suspected cases promptly to an ophthalmologist.
Limited impact expected on prescribing
The class includes about a dozen injectable and pill-based drugs used for diabetes, obesity and related conditions, among them Eli Lilly’s newly approved oral drug Foundayo. Citi analysts told CNBC the labeling change is “likely to attract attention but should have limited impact on GLP-1 uptake,” given the rarity of the condition and the drugs’ broad cardiovascular, kidney and weight-loss benefits.
Sources & Credits
- U.S. Food and Drug Administration: FDA requires safety labeling changes for GLP-1 RAs due to potential increased risk of rare but serious eye condition
- CNBC: FDA warns of vision loss risk linked to popular GLP-1 drugs like Wegovy, Zepbound
- USA Today: Do GLP-1s cause vision loss? Explaining new FDA warning
- Associated Press: FDA adds rare vision-loss warning to popular GLP-1 drugs
Image: Ozempic pen by HualinXMN, CC BY-SA 4.0, via Wikimedia Commons.
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