Key facts
- The FDA is requiring NAION risk information in the Warnings and Precautions labeling of all GLP-1 receptor agonist products.
- The FDA reviewed 126 clinical trials with more than 134,200 patients and identified 15 probable NAION cases.
- Ten probable cases were among GLP-1 patients, five among placebo patients and none among non-GLP-1 glucose-lowering patients.
- The FDA reported 6.4 NAION cases per 100,000 person-years among GLP-1 patients versus 3.8 for placebo or alternative medications.
- Novo Nordisk said the data do not establish cause and effect and that it remains confident in its GLP-1 medicines' benefit-risk profile.
- The FDA said NAION cases have been reported for all currently marketed GLP-1 RA products.
The US Food and Drug Administration is requiring makers of GLP-1 receptor agonist medications to add information about the risk of nonarteritic anterior ischemic optic neuropathy, or NAION, to the Warnings and Precautions section of all such products' labeling, The Guardian reported on November 10, 2026. The agency announced the requirement on Monday, November 9, 2026, according to the report. The affected products named include Novo Nordisk's Ozempic and Wegovy, Eli Lilly's Mounjaro and Zepbound, and Sanofi's Soliqua.
NAION is a rare condition in which blood flow to the optic nerve suddenly drops, causing acute, painless vision loss in one eye that can be permanent, the FDA said. The agency said there is no treatment to reverse the vision loss. It is the most common cause of acute optic nerve injury in people over 50, with an annual average of 2.3 to 10.2 cases per 100,000 people in that age group, according to the report. Risk factors cited include diabetes, smoking, hypertension and hypercholesterolemia.
The FDA said it began examining a possible link after a 2024 study in the journal JAMA Ophthalmology found an increased NAION risk among patients using GLP-1 medications. Despite limitations it identified in that study, the agency said it "determined that further assessment of the potential increased risk for NAION was warranted." It then reviewed 126 clinical trials involving more than 134,200 patients and identified 15 probable NAION cases: 10 among GLP-1 patients, five among patients receiving placebo, and none among patients on glucose-lowering medications that were not GLP-1. The FDA reported an incidence rate of 6.4 cases per 100,000 person-years among GLP-1 patients, against 3.8 cases among patients on placebo or alternative glucose-lowering medications.
"NAION cases have been reported for all currently marketed GLP-1 RA products," the FDA said, adding that it "concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs." The agency said that finding is the basis for the labeling requirement.
A Novo Nordisk spokesperson told The Guardian that the company "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." The spokesperson added: "Patient safety is a top priority for Novo, and we continue to monitor the safety of our medicines, review new research and work with health authorities around the world." The Guardian said it had reached out to Eli Lilly and Sanofi for comment and that Eli Lilly had previously said it is aware of publications on the risk of NAION among GLP-1 patients.
GLP-1 medications are mainly used by people with type 2 diabetes to manage blood sugar, and some are also used to treat obesity. The FDA announcement came as the Netherlands-based non-profit Access to Medicine Foundation warned that pharmaceutical focus on GLP-1 weight-loss drugs risks putting global insulin supply at risk, the report said.