The FDA says manufacturers must warn of a potential risk of a rare eye condition that can cause permanent vision loss. An ophthalmology group says any increase in absolute risk appears small and causation has not been established.
The US Food and Drug Administration said on 9 November 2026 that manufacturers must add warnings to GLP-1 medicine labels about a potential increased risk of a rare eye condition that can cause permanent vision loss. The requirement covers medicines used for diabetes and weight loss, including Novo Nordisk’s Ozempic and Wegovy, Eli Lilly’s Mounjaro and Zepbound, and Sanofi’s Soliqua.
The American Academy of Ophthalmology says there may be an association, but the condition remains rare, any increase in absolute risk appears small, and causation has not been established. The European Medicines Agency had already required a label change for semaglutide, the active ingredient in Ozempic and Wegovy, after its 2025 review. It classified NAION as a very rare side effect that may affect up to one in 10,000 people taking semaglutide.
The condition, non-arteritic anterior ischemic optic neuropathy (NAION), occurs when reduced blood flow damages the optic nerve. Swelling and cell death can cause sudden, painless vision loss, typically in one eye; the loss can be permanent, and there is no known treatment to reverse it.
The FDA began its investigation after a 2024 study found a higher NAION risk among patients prescribed semaglutide. The agency said the study had limitations but prompted a broader review. The Harvard study examined 710 patients with diabetes and 979 with overweight or obesity, comparing semaglutide with non-GLP-1 diabetes or weight-loss medicines in each group. As Ars Technica explains, the study drew patients from a single referral center with unusually high NAION rates and did not account for diabetes severity. The high rates suggest possible selection bias and limit the generalizability of the findings. Later studies produced mixed results, with some finding a link only in particular comparisons. A meta-analysis of 78 randomized trials found no increased risk of eye disorders overall with semaglutide, but did find an increased NAION risk; that finding relied on only five trials reporting NAION. An electronic-records study generally found no link, with increased risk appearing only when semaglutide was compared with empagliflozin, one of three comparator drugs, and a case definition requiring a confirmatory diagnostic code was used.
The FDA’s analysis of 126 clinical trials involving more than 134,000 patients identified 15 probable NAION cases: 10 among people receiving GLP-1 medicines, 5 among placebo recipients and none among those receiving non-GLP-1 medicines. The FDA found 6.4 cases per 100,000 person-years among GLP-1 users, compared with 3.8 among people receiving a placebo or another diabetes medicine. A person-year represents one person followed for one year.
In a separate study looking back at people with type 2 diabetes who took medicines between 2019 and 2024, the FDA found no increased NAION risk with GLP-1 medicines compared with one group of diabetes drugs, SGLT-2 inhibitors. It found an increased risk compared with another group, DPP-4 inhibitors.
Assessing the possible link is complicated because NAION risk factors, including diabetes, cardiovascular disease, high blood pressure, high cholesterol, metabolic syndrome and obstructive sleep apnea, are common among people taking GLP-1 medicines. How the medicines might contribute to NAION is unknown. The academy says most research has focused on semaglutide, and whether an association differs between medicines or patient groups remains uncertain.
The FDA advises patients with sudden vision loss in one eye, blurred vision or blind spots to contact a health care professional immediately. For patients who develop NAION, the agency advises clinicians to consider stopping the GLP-1 medicine unless the benefits clearly outweigh the risk. The European regulator instead recommended stopping semaglutide if NAION is confirmed.
In May 2026, the American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society recommended that patients with NAION or an elevated risk decide with their care team whether to start, continue or stop treatment. The academy said subsequent data had not changed its recommendation and that the FDA’s position was broadly consistent with the joint statement. The academy says those decisions should account for the reason for treatment, overall health, alternatives and potential risk to the other eye, alongside the medicines’ benefits.
Novo Nordisk told ABC News that the research does not establish a cause-and-effect relationship and that it remains confident in its medicines’ benefit-risk profile. It said it continues to monitor safety, review research and work with health authorities.
Eli Lilly said the FDA communication covers all medicines with GLP-1 receptor agonist activity and does not refer to findings specific to its medicines. The company said it was evaluating the update and would respond promptly to the FDA.
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