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FDA Requires NAION Warnings for Ozempic, Wegovy, Mounjaro, Zepbound, Other GLP-1 RAs in November 2026

Compare: Ophthalmology Groups AAO and NANOS Implied in September 2026 NAION Warnings Were Not Necessary For Semaglutide Drugs

(Posted by Tom Lamb at Drug Injury Watch)

Overview: Starting in November 2026, the FDA requires NAION warnings for Ozempic and Wegovy (semaglutide-containing drugs), Mounjaro and Zepbound (tirzepatide-containing drugs), and other GLP-1 RA medications.

As announced in this November 9, 2026, Drug Safety Communication, “FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition“, the Warnings and Precautions section of US drug labels for all GLP-1 RA medications will add information about the potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the use of these medications.

As for what the FDA seeks to accomplish, in part, by requiring that these NAION warnings be added to the US drug labels for Ozempic, Wegovy, Mounjaro, Zepbound, and other GLP-1 RA medications, it wants this information made available to people using these increasingly popular medications:

Patients and caregivers should be aware of a potential increased risk of NAION, a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss, with GLP-1 RA use.

Symptoms of NAION include sudden, painless vision loss in one eye that patients may notice upon waking; blurred or missing portions of vision (visual defects such as blind spots or tunnel vision); distortion of colors; and reduced central sharpness (e.g., blurry or hazy spots). Patients should contact their health care professional right away if they have any of these symptoms.

If a patient has had a NAION event, they should talk with their health care professional about whether to continue taking their GLP-1 RA medication or to stop it.

We have been investigating drug injury lawsuits for people who have been diagnosed with NAION for the past couple of years, even before this November 2026 FDA action that requires NAION warnings. We have been focusing on cases for people who were using Ozempic, Wegovy, or Rybelsus — all of which are semaglutide-containing drugs — as well as people who were using Zepbound or Mounjaro — both of which are tirzepatide-containing drugs.

As a comparison to this November 2026 FDA action requiring NAION warnings for Ozempic, Wegovy, and Rybelsus (semaglutide-containing drugs), we point out that in September 2026 the American Academy of Ophthalmology (AAO) and the North American Neuro-Ophthalmology Society (NANOS) seemed to assert that such NAION warnings were not necessary.

In a relevant part of “What The Data Say About GLP-1 Drugs and Vision Loss“, a September 22, 2026 News Release issued by the American Academy of Ophthalmology:

Last year, when the European Medicines Agency called for product labeling to include NAION as a ‘very rare’ side effect and recommended stopping semaglutide if NAION is confirmed, the Academy and NANOS recommended a different approach.

The Academy and NANOS do not support such a blanket recommendation for all patients. It’s important to remember that for patients with severe obesity, hard-to-control diabetes, or cardiovascular disease, abruptly stopping the drug can be riskier than a rare eye event.

Instead, the Academy and NANOS recommend that patients who develop NAION while on semaglutide engage in a shared decision-making process with their physicians, including their ophthalmologist, neuro-ophthalmologist, neurologist, primary care physician, or endocrinologist. This discussion should consider the individual’s overall health, risk factors, and therapeutic options, including the potential risk to the fellow eye, to make an informed decision about whether to continue or discontinue semaglutide.

Where do we stand regarding this apparent disagreement between the FDA and these two Ophthalmology groups, AAO and NANOS?

The subtitle of our October 16, 2026 article, “Vision Loss Associated With Ozempic, Mounjaro, And Other GLP-1 Drugs“, was “People With Vision Loss Want Warnings Even If Risk Of NAION Eye Injury Is Low”, so we believe that the FDA requiring these new NAION warnings in November 2026 was the right course of action (and overdue).

Going back to the drug injury lawsuits mentioned above, we offer a free online case evaluation service for people diagnosed with NAION while using Ozempic, Wegovy, or Rybelsus (those semaglutide-containing drugs) as well as people diagnosed with NAION while using Zepbound or Mounjaro:

Ozempic / Wegovy / Rybelsus Vision Loss Case Evaluation Form

Zepbound / Mounjaro Eye Side Effect NAION Case Evaluation Form

And here are two other ways you can have your potential NAION lawsuit reviewed by drug injury lawyer Tom Lamb: (1) Send an email to TJL@LambLawOffice.com or (2) Call our office at 910-256-2971.

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