We are notifying you that the U.S. Food and Drug Administration (FDA) published a safety communication on November 9, 2026, regarding the following product(s): GLP-1 receptor agonists (GLP-1s).
Reason for Communication
The FDA required labeling updates for all GLP-1s to include a warning about the potential risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden, painless vision loss and may result in permanent vision loss..
The decision was based on FDA’s review of clinical trial data, real-world data from the FDA Sentinel System and published observational studies. The clinical trial analysis pooled 126 randomized, controlled trials across GLP-1 development programs, covering 134,253 patients (78,217 treated with a GLP-1 and 56,036 comparator patients) and 288,879 person-years (PY) of exposure. FDA identified 15 probable NAION events: 10 among GLP-1 users, 5 among patients receiving placebo, and none among patients receiving other non-GLP-1 glucose-lowering medications.
This corresponds to 6.4 NAION cases per 100,000 PY in patients treated with GLP-1 RAs compared with 3.8 cases per 100,000 PY in patients who received placebo or another non-GLP-1 RA glucose-lowering medication. The absolute risk remains rare. For context, FDA cites a background rate of 2.3 to 10.2 NAION cases per 100,000 persons per year in the general population of adults older than 50.
Pharmacy Required Action
Advise patients to immediately report sudden onset of acute, painless, decreased vision; visual field deficits; or other visual disturbances in one eye. If NAION is suspected, promptly refer the patient to an ophthalmologist for evaluation. Patients with a history of NAION are at increased risk.
Remember you can report adverse events related to this or any other drug product at MedWatch: The FDA Safety Information and Adverse Event Reporting Program by any of the following ways:
- Complete and submit the MedWatch Online Voluntary Reporting Form online.
- Download FDA Form 3500 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
- Additional information can be found at: MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
If you have any questions or wish to have more information regarding this document, you can call us at 787-522-5252-ext. 219. Our pharmacists will help you.
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