The FDA has issued a new safety warning for all glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications sold in the United States following new evidence of the potential increased risk for nonarteritic anterior ischemic optic neuropathy (NAION).
The federal agency announced its concerns on Nov. 9 in a statement addressed to patients and healthcare providers (HCPs).
Let’s take it from the top.
Starting with GLP-1 RAs: These are a class of medications typically used to treat type 2 diabetes mellitus (T2D), obesity—and, more recently, managing cardiovascular risk and chronic kidney disease (among other conditions).
Accounting for an estimated 70% of all GLP-1RA treatments in the U.S., the majority of FDA-approved treatments include:
- Semaglutide (Ozempic and Wegovy)
- Tirzepatide (Mounjaro and Zepbound)
Check out all approved GLP-1 RAs in the United States.
Now to these concerns.
This cause for concern is based on NAION, which the FDA refers to as “a rare condition that can result in acute, painless, decreased vision in one eye, including permanent vision loss.”
And what action is the federal agency taking?
The FDA is requiring all GLP-1 RA application holders to update their respective medications’ warning and precautions section of labeling to include the potential increased risk for NAION associated with use.
So how should patients and doctors be responding to this?
For patients: awareness of this potential increased risk is critical.
The FDA noted several symptoms they should be on the lookout for, including sudden, painless vision loss in one eye upon waking; visual defects, such as blind spots or tunnel vision; distortion of colors; and reduced central sharpness (e.g., blurry or hazy spots).
- If experiencing any of these, they’re advised to contact their healthcare provider (HCP) immediately.
- See here for potential risk factors that may increase the potential for NAION development.
How about for HCPs?
Similar to patients: They’re asked to be aware of this potential increased risk for NAION development among their GLP-1RA patients and have them (their patients) immediately report any ocular changes.
If NAION is suspected: Patients should be referred to an ophthalmologist for evaluation.
And what if a patient does develop NAION?
The FDA’s recommendation: Speak with their HCP about whether or not to continue taking their GLP-1 RA medication.
Along with this: Adverse events should be reported to the FDA by completing an online voluntary reporting form (click here) or calling the agency directly.
So why is the FDA issuing this warning now?
Great question, particularly considering that the potential association between rare ocular diseases and GLP-1 RAs isn’t necessarily a new discovery.
Case in point: We’ve previously reported on the growing number of reports linking the medications to various ocular adverse events—including optic nerve damage.
And in 2025: The American Optometric Association (AOA) released a clinical report that identified and analyzed a growing collection of research highlighting the potential ocular risks.
Speaking of the AOA—has it commented on this latest development?
Yes. The organization stated the FDA's latest action reinforces a message it has “consistently championed: Patients taking GLP-1 medications deserve proactive, comprehensive eye care as part of their overall health care.”
Alrighty, now let’s circle back to the reason for the FDA’s warning.
The FDA referenced clinical research published in July 2024 in which it identified “several limitations” that indicated further assessment of "the potential increased risk for NAION was warranted."
The complicated nature of the data was a factor in the timeframe for this, as the agency noted:
- NAION cases have been reported for every GLP-1RA now on the market.
- Adverse event reports alone were hard to interpret because NAION risk factors “often overlap with conditions common in patients treated with GLP-1RAs.”
As such: The federal agency conducted a comprehensive evaluation of various data (clinical trial, animal, and postmarketing) encompassing observational studies and case reports.
Tell us more about this evaluation.
In a clinical trial meta-analysis: The agency pooled 126 trials with 134,253 patients, in which 15 probable NAION events were identified:
- 10 in GLP-1 RA users
- 5 in placebo users
- None in patients on other glucose-lowering drugs
The final tally: 6.4 events per 100,000 patient-years with GLP-1 RAs vs. 3.8 with comparators.
And in a real-world cohort involving the FDA’s Sentinel Real-World Evidence Data Enterprise (RWE-DE) Commercial Network. researchers followed adults with T2D who started a GLP-1 RA or two other diabetes medications between 2019 and 2024.
- NAION rates ranged from 26 to 32 events per 100,000 patient-years.
- GLP-1 RA use was associated with a higher NAION risk than one of the other diabetes medications. See here for those numbers.
Anything else?
Lastly, the federal agency reviewed published studies in which it found “methodologically rigorous studies consistently reported an increased risk” of NAION with GLP-1 RAs compared with DPP-4 or SGLT-2 inhibitors in patients with type 2 diabetes.
The FDA noted that those results were “generally consistent” with its own analyses.
… which brings us to its final conclusion?
Indeed. Based on those findings, the FDA reasoned that “there is potential increased risk of rare NAION events in patients taking GLP-1 RAs,” and added that aforementioned safety label update requirement for GLP-1 RA application holders.