The U.S. Food and Drug Administration is requiring manufacturers of GLP-1 drugs to add warnings to their labels regarding a rare eye condition that can cause permanent vision loss.
On Monday, Nov. 9, 2026, federal regulators announced the new safety labeling rule for all medications in the glucagon-like peptide-1 receptor agonist class, including popular brands such as Ozempic, Wegovy, Zepbound, and Mounjaro.
FDA identifies NAION risk
The mandate addresses non-arteritic anterior ischemic optic neuropathy, or NAION, a condition caused by decreased blood flow to the optic nerve. The FDA concluded there is a potential increased risk of rare NAION events in patients taking these medications, USA Today reported.
The agency’s decision followed a review of clinical trial data, animal studies, and post-marketing information. This included a July 2024 study published in JAMA Ophthalmology that found diabetes patients prescribed semaglutide were significantly more likely to develop the condition.
Specifically, investigators at one academic institution reported a higher risk of NAION with semaglutide compared to non-GLP-1 RA medications in patients with type 2 diabetes, citing a hazard ratio of 4.28 with a 95% confidence interval of 1.62-11.29.
Do GLP-1s cause vision loss? Explaining new FDA warning
Symptoms of NAION include sudden, painless vision loss in one eye, blurred vision, blind spots, color distortion, and hazy spots affecting central vision. WCVB noted that patients may first notice these changes upon waking.
The condition, sometimes referred to as an “eye stroke,” can result in decreased vision in one eye, and a patient could experience mild loss in one eye followed by severe loss in the next. While some vision may improve, the structural damage is typically permanent, and those who experience it in one eye are more likely to develop it in the other.
Comparing incidence rates
While the FDA noted that the absolute risk remains small, an analysis of 126 clinical trials involving 134,253 patients identified 15 probable cases of NAION. ABC News reported that 10 of these cases occurred in GLP-1 users, while five were among placebo recipients. The FDA noted that no cases occurred in patients receiving other glucose-lowering medications. Of the total patients reviewed, 78,217 received a GLP-1 RA and 56,036 received a comparator, totaling 288,879 person-years of exposure.
The following table compares the observed incidence of NAION among different patient groups based on FDA findings:
| Patient Group | NAION Cases per 100,000 Person-Years |
|---|---|
| GLP-1 Users | 6.4 |
| Placebo or other diabetes medications | 3.8 |
In a separate study tracking nearly 175,000 diabetic patients treated with semaglutide alongside an equal number of patients on non-GLP-1 medications, the risk of NAION more than doubled after two years of treatment. However, a Cleveland Clinic study of approximately 220,000 GLP-1 users with type 2 diabetes, including about 120,000 on semaglutide, found no statistically significant increase in NAION risk.
The American Academy of Ophthalmology notes that NAION is the second most common optic nerve disease in the U.S., affecting up to 10 out of every 100,000 people over age 50.
GLP-1 drugs, popular for weight loss, get FDA warning
Manufacturer and medical reactions
The Independent quoted Liz Skrbkova, who leads U.S. media and stakeholder relations for Novo, saying, 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.
Skrbkova 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.
Eli Lilly, which produces Zepbound and Mounjaro, said it is evaluating the update.
A spokesperson for the company told ABC News, FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines. We are carefully evaluating the update and will respond to FDA promptly.
Another Lilly spokesperson told The Independent, If anyone is experiencing side effects when taking a Lilly medicine, they should talk to their doctor or other healthcare professional.
Citi analyst Geoff Meacham suggested that while the FDA action might temporarily increase concern for patients and investors, the rarity of the condition and the substantial benefits regarding weight, glycemic control, cardiovascular health, renal health, and sleep apnea should preserve a favorable benefit-risk profile and limit changes to prescribing.
Medical professionals have responded to the mandate. Dr. Manjot Gill, an ophthalmologist at Northwestern Medicine in Chicago, told NBC News that the FDA’s requirement for a warning label was appropriate.
However, Dr. Gill noted that the condition is extremely rare and expressed a desire to avoid unnecessary patient anxiety. We don’t want patients to really get overly concerned and anxious and to stop these medications,
Gill told NBC News.
Ongoing litigation and legal claims
The FDA’s decision comes amid significant legal pressure. Thousands of lawsuits have been filed in state and federal courts, including at least 4,000 complaints consolidated into larger federal multidistrict litigation.
The lawsuits generally allege permanent vision loss and damage resulting from the use of Ozempic, Wegovy, Zepbound, Mounjaro, and Trulicity. In November 2025, Denmark’s patient compensation body, which is funded by insurers and the state, awarded four claimants a combined 800,000 Danish kroner, approximately $124,000, after they reported vision loss after using Wegovy or Ozempic.
The FDA has advised healthcare providers to consider discontinuing the (GLP-1) in patients who develop NAION, unless the benefits of treatment clearly outweigh the risk,
according to USA Today. The agency also instructs doctors to refer patients with suspected vision-related symptoms to an eye specialist immediately.