FDA lists NAION as a potential signal for the GLP-1 class, naming Mounjaro and Zepbound
FDA's quarterly adverse-event report for October–December 2024 flagged a rare eye condition, NAION, as a potential signal across 14 GLP-1 products including Ozempic, Wegovy, Mounjaro and Zepbound [1].
The US Food and Drug Administration listed non-arteritic anterior ischemic optic neuropathy (NAION) as a potential signal of a serious risk for the entire glucagon-like peptide-1 (GLP-1) receptor agonist class in its October–December 2024 quarterly report from the FDA Adverse Event Monitoring System (AEMS) [1]. The status note in the table reads: "FDA is evaluating the need for regulatory action" [1].
What the FDA listing says
The entry covers 14 named products: Adlyxin (lixisenatide) injection, Bydureon (exenatide) for extended-release injectable suspension, Bydureon BCise (exenatide extended-release) injectable suspension, Byetta (exenatide) injection, Mounjaro (tirzepatide) injection, Ozempic (semaglutide) injection, Rybelsus (semaglutide) tablets, Saxenda (liraglutide) injection, Soliqua 100/33 (insulin glargine and lixisenatide) injection, Trulicity (dulaglutide) injection, Victoza (liraglutide) injection, Wegovy (semaglutide) injection, Xultophy 100/3.6 (insulin degludec and liraglutide) injection, and Zepbound (tirzepatide) injection [1]. FDA also notes that products on the list may include approved generic versions of those drugs [1].
The table gives the condition's name and nothing more. It does not include case counts, reporting rates, the time period over which reports accumulated, patient characteristics, or any assessment of whether the drugs caused the events [1]. The "Additional Information" column for the GLP-1 entry was current as of March 6, 2025, and at that point listed no label change, safety communication or other action [1].
That contrast matters, because FDA does fill in that column when it acts. In the same quarterly table, the entry for Veozah (fezolinetant) tablets and drug-induced liver injury states that the Boxed Warning, Dosage and Administration, Warnings and Precautions, and Patient Counseling Information sections were updated in December 2024, and that a Drug Safety Communication was issued September 12, 2024 and updated December 20, 2024 [1]. Several immune globulin entries similarly point to voluntary lot withdrawals [1]. The GLP-1 entry carries only the "evaluating the need for regulatory action" language [1].
NAION is not the only eye-related item in the quarter. FDA separately listed "optic neuropathy" as a potential signal for the cancer drugs Alecensa (alectinib), Alunbrig (brigatinib), Lorbrena (lorlatinib) and Zykadia (ceritinib), also with the same "evaluating" status [1]. The quarter's list runs long and includes items such as hearing loss with proton pump inhibitors and constipation with migraine drugs [1].
Why it matters for patients
Appearing on this list is an early regulatory step, not a conclusion. The page is titled as covering "New Safety Information or Potential Signals of Serious Risks" identified from adverse event reports [1], and for this entry FDA stated only that it is evaluating whether regulatory action is needed [1]. The document does not say that GLP-1 medicines cause NAION, and it does not quantify any risk [1].
Practically, this means the labels for semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound) and the other listed products did not change as a result of this listing, at least as of the March 6, 2025 update reflected in the table [1]. People taking these drugs will not find NAION language added to their prescribing information based on this document alone. Whether FDA has since added any NAION language to a US GLP-1 label is not addressed in this source, and no later FDA document is provided here.
It is also worth noting what a class listing does and does not imply. FDA grouped all 14 products together rather than singling out one molecule [1], so the entry does not distinguish between semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide or lixisenatide in terms of reported cases [1].
What happens next
FDA publishes these AEMS summaries quarterly, and updates the "Additional Information" column when the status changes, as it did for Veozah [1]. The October–December 2024 table was current as of March 6, 2025 [1]. No timeline for completing the GLP-1 NAION evaluation is given in the document, and none of the three possible outcomes — a label change, a safety communication, or no action — is stated as likely [1]. Questions about symptoms, monitoring or whether to continue treatment are matters for a clinician; this FDA listing does not provide guidance on any of them [1].
Sources
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