| Safety and regulation
The U.S. Food and Drug Administration said on November 9, 2026, in a Drug Safety Communication, that it is requiring every GLP-1 receptor agonist medicine to add information about a potential increased risk of non-arteritic anterior ischemic optic neuropathy, known as NAION, to the Warnings and Precautions section of its label. The notice lists 12 products: semaglutide (Ozempic, Rybelsus, Wegovy), tirzepatide (Mounjaro, Zepbound), orforglipron (Foundayo), dulaglutide (Trulicity), liraglutide (Victoza, Saxenda), exenatide, and the insulin combinations Xultophy and Soliqua.
NAION happens when blood flow drops to the front of the optic nerve. It causes sudden, painless vision loss in one eye, often noticed on waking, and the loss can be permanent. FDA calls the risk potential. It found no mechanism in animal data, and it said reports to its adverse event database were hard to interpret because NAION risk factors, including diabetes, high blood pressure and sleep apnea, are common in people who take these medicines.
FDA pooled 126 clinical trials covering 134,253 patients. It counted 15 probable NAION events: 10 in people taking a GLP-1 medicine, 5 in people taking placebo and none in people taking other glucose-lowering drugs. That works out to 6.4 events per 100,000 person-years with GLP-1 medicines and 3.8 with comparators. FDA also ran its own Sentinel cohort study in adults with type 2 diabetes from 2019 to 2024, where NAION rates ranged from 26 to 32 per 100,000 person-years across groups. Compared with SGLT-2 inhibitors, GLP-1 medicines showed no statistically significant increase (hazard ratio 1.19, 95% confidence interval 0.91 to 1.54). Compared with DPP-4 inhibitors, they showed a higher risk (hazard ratio 1.43, 95% confidence interval 1.02 to 2.01).
The U.S. labels the Atlas read before today did not name NAION. FDA says NAION has been reported with every GLP-1 medicine now marketed, so this is a class-wide change. Europe's safety committee concluded in June 2025 that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people, and U.K. and Australian regulators followed. The Atlas has not yet seen the revised U.S. label text.
Studies disagree about how large any added risk is. A 2026 meta-analysis of eight observational cohorts in people with type 2 diabetes found higher NAION risk with GLP-1 medicines, while a 2026 military health records study found lower odds with semaglutide than with other diabetes medicines. A 2026 ophthalmology study found that optic disc shape was the same whether or not people had taken GLP-1 medicines, and that a small cup-to-disc ratio (a crowded disc, an eye feature people are born with) carried far higher odds of NAION. Its authors say it cannot show whether GLP-1 medicines are an independent risk factor.
FDA tells patients to contact a health care professional right away about sudden vision loss in one eye, blind spots or tunnel vision, distorted colors, or blurry or hazy central vision. It tells clinicians to refer suspected NAION to an ophthalmologist promptly and to consider stopping the GLP-1 medicine in a patient who develops it, unless the benefits clearly outweigh the risks. After NAION in one eye, the other eye has a higher risk, and FDA says people who have had NAION face a higher chance of recurrence.
Worth knowing: A label warning records a potential risk. It does not by itself show that a medicine causes NAION. Sudden loss of vision in one or both eyes needs urgent medical care. The Atlas will update this page when the revised label text is published.
Related: Vision loss and NAION guide | Semaglutide | Tirzepatide
Sources: FDA, Drug Safety Communication: FDA requires safety labeling changes for GLP-1 receptor agonists due to potential increased risk of rare but serious eye condition, November 9, 2026; Reuters, US FDA orders new eye risk warnings for Ozempic, Zepbound (via Yahoo News), November 9, 2026; Lampsas et al., Graefes Archive for Clinical and Experimental Ophthalmology, 2026; Lieberman et al., Military Medicine, 2026; Robertson et al., Ophthalmology, 2026.