The US Food and Drug Administration (FDA) has ordered the makers of GLP-1 weight-loss and diabetes drugs — including Ozempic, Wegovy, Mounjaro and Zepbound — to add a warning about a rare eye condition that can cause sudden vision loss.
In a Drug Safety Communication published on Monday, 9 November 2026, the FDA said it is requiring all makers of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medicines to 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.
NAION is a rare condition in which blood flow to the front of the optic nerve drops. The FDA describes it as a condition that can cause acute, painless, decreased vision in one eye, including permanent vision loss, and says its underlying cause is not completely understood.
The FDA’s review was prompted by a July 2024 study in JAMA Ophthalmology that examined NAION risk in patients prescribed semaglutide. The agency then carried out a comprehensive evaluation of clinical trial data, animal data and post-marketing reports.
In a meta-analysis of 126 randomised controlled trials covering 134,253 patients and 288,879 person-years of exposure, the FDA found 15 probable NAION events — 10 in patients treated with a GLP-1 drug and five in patients given a placebo. The rate was 6.4 events per 100,000 person-years among GLP-1 users, compared with 3.8 per 100,000 among patients on a comparator drug.
A separate FDA real-world study of adults with type 2 diabetes found NAION rates of 30 to 32 events per 100,000 person-years among GLP-1 users, broadly similar to rates for other diabetes medicines, and the agency said its animal-data review found no mechanism by which GLP-1 drugs could increase the risk. Even so, the FDA concluded there is a potential increased risk and is requiring the label change.
The warning applies to the whole class of GLP-1 drugs, including semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity), the combination products Xultophy and Soliqua, and orforglipron (Foundayo), approved in 2026. The FDA said NAION cases have been reported for every GLP-1 product currently on the market.
The action is a labelling change, not a withdrawal, recall or restriction of any product.
The FDA advised patients to report immediately any sudden, painless loss of vision, a visual field defect or other visual change in one eye, and said doctors should refer patients with suspected NAION promptly to an ophthalmologist. The agency said risk factors for NAION may include smoking, diabetes, high blood pressure, sleep apnea, anemia and kidney disease.
Drugmaker Eli Lilly said it was ‘carefully evaluating the update’ and would respond to the FDA promptly, noting the communication applies to all medicines with GLP-1 activity and does not reference findings specific to its medicines.
Source: US Food and Drug Administration — https://www.fda.gov/drugs/drug-safety-communications/fda-requires-safety-labeling-changes-glucagon-peptide-1-receptor-agonists-glp-1-ras-due-potential
