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FDA orders NAION eye-risk warnings on Ozempic, Zepbound and other GLP-1 drugs
The FDA said Monday it is requiring all GLP-1 receptor agonist labels to warn of a potential increased risk of NAION, a rare cause of sudden, painless vision loss.
- New headline Was: “US FDA orders new eye risk warnings for Ozempic, Zepbound”
- Our desk filed its story
The U.S. Food and Drug Administration said Monday it is requiring makers of glucagon-like peptide-1 receptor agonist medicines to add a warning about a potential increased risk of non-arteritic anterior ischemic optic neuropathy, or NAION, a rare condition that can cause sudden, painless vision loss in one eye, including permanent loss1,2.
The class includes Novo Nordisk's Ozempic, Wegovy and Rybelsus (semaglutide), Eli Lilly's Mounjaro and Zepbound (tirzepatide), and other GLP-1 products used for type 2 diabetes, weight reduction and additional approved uses1,2.
An FDA meta-analysis of 126 randomized trials covering 134,253 patients found 6.4 probable NAION cases per 100,000 person-years among GLP-1 users versus 3.8 among people on placebo or a non-GLP-1 glucose-lowering drug; 15 probable events were identified (10 on GLP-1 drugs, 5 on placebo)2.
A Sentinel real-world study did not find a statistically significant increase versus SGLT-2 inhibitors (hazard ratio 1.19, 95% CI 0.91-1.54) but did versus DPP-4 inhibitors (1.43, 1.02-2.01); incidence in that diabetes cohort was about 26 to 32 events per 100,000 person-years2.
The agency said NAION reports exist for all currently marketed GLP-1 products, that animal data did not show a mechanism, and that overlapping risk factors such as diabetes and high blood pressure make spontaneous reports hard to interpret2.
FDA told patients to seek care promptly for sudden painless vision loss, visual-field gaps or other one-eye visual changes, and told clinicians to refer suspected NAION to an ophthalmologist and consider stopping the drug unless benefits clearly outweigh the risk2.
Not medical advice.
