The FDA is requiring GLP-1 drugmakers to add warnings about a potential increased risk of a rare eye condition that can permanently impair sight, Reuters and USA TODAY report. The agency announced the requirement on Nov. 9, 2026. SourceSource
The requirement includes Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. The information must appear in the “warnings and precautions” section of the drugs’ labeling, Reuters reports. Source
The condition is non-arteritic anterior ischemic optic neuropathy, or NAION. It involves decreased blood flow to the front part of the optic nerve, although the underlying cause is not completely understood. Rare doesn’t mean minor here: NAION can cause sudden, painless vision loss and, in some cases, permanent impairment. SourceSource
What’s behind the warning
The FDA evaluated clinical trial data, animal data and evidence collected after the medicines reached the market, including observational studies and case reports, according to the reports. SourceSource
USA TODAY reports that the agency’s clinical trial analysis identified 15 probable NAION cases: 10 among patients treated with GLP-1 drugs and five among patients receiving a placebo. The newspaper also reports rates of 6.4 cases per 100,000 GLP-1-treated patients, compared with 3.8 per 100,000 in comparison groups. Source
USA TODAY does not say what period those rates cover, so they should not be read as yearly risk estimates. The report also does not say how precise the estimates are or whether the difference was statistically significant. The FDA’s conclusion, as quoted by USA TODAY, is that “there is a potential increased risk of rare NAION events in patients” taking GLP-1 medicines. Source
How the manufacturers responded
A Novo Nordisk spokesperson told Reuters: “Novo continues to believe the data do not establish a cause-and-effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines.” Source
Lilly said the FDA communication applies to all medicines with GLP-1 receptor agonist activity and does not reference findings specific to its products. “We are carefully evaluating the update and will respond to FDA promptly,” a spokesperson told Reuters. Source
The Reuters and USA TODAY reports do not specify when manufacturers must add the new wording. SourceSource
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