FDA flags rare eye condition as possible signal for GLP-1 drugs including Mounjaro and Zepbound
The FDA is reviewing a possible link between GLP-1 medicines such as Ozempic, Wegovy, Mounjaro and Zepbound and a rare optic nerve condition, but has made no decision and changed no labels.
Federal regulators flagged a rare eye condition as a possible safety signal for the entire GLP-1 receptor agonist class — including the diabetes drug Mounjaro and the weight-loss drug Zepbound — in a quarterly review of side effect reports covering October through December 2024 [1].
The entry lists non-arteritic anterior ischemic optic neuropathy, or NAION, as a "potential signal of a serious risk" for the drug class. In the column the FDA uses for follow-up notes, the entry reads, "FDA is evaluating the need for regulatory action." That column is dated as of March 6, 2025, and adds no detail about what the agency is reviewing or what action it might take [1].
The GLP-1 entry names 14 products: Adlyxin (lixisenatide), Bydureon, Bydureon BCise and Byetta (exenatide), Mounjaro (tirzepatide), Ozempic and Rybelsus (semaglutide), Saxenda and Victoza (liraglutide), Soliqua 100/33 (insulin glargine and lixisenatide), Trulicity (dulaglutide), Wegovy (semaglutide), Xultophy 100/3.6 (insulin degludec and liraglutide) and Zepbound (tirzepatide) [1].
The report does not say how many NAION cases were reported, how serious they were, or whether the people affected were taking the drugs for diabetes or for weight loss. Those details have not been disclosed [1]. The listing also does not state that the FDA has concluded these drugs cause NAION; it says only that the agency is evaluating whether regulatory action is needed [1].
NAION was one of dozens of potential signals in the same quarterly report. Another entry, for four cancer drugs — Alecensa (alectinib), Alunbrig (brigatinib), Lorbrena (lorlatinib) and Zykadia (ceritinib) — listed optic neuropathy, with the same note that the FDA is evaluating the need for regulatory action [1].
Why it matters for patients
A potential signal is a flag for further review, not a finding that a drug caused a problem. The FDA's entry for the GLP-1 class says the agency is still evaluating whether any regulatory action is needed [1].
No NAION warning has been added to any US label for these medicines, and the FDA has not announced a decision about the signal [1]. For the 14 products on the list, the approved uses and the prescribing information are unchanged.
For someone taking semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound) or another GLP-1 medicine, the practical effect of the listing is informational: it tells the public that the FDA is looking at a possible link, without saying how strong or how likely that link is [1].
What is not yet known is how common NAION is among people taking these drugs, whether it is more likely in people with diabetes or other risk factors, and how long patients had been on treatment when cases were reported. The report does not address any of that [1].
What happens next
The FDA has not given a date for a decision on the NAION signal [1]. The report's follow-up note is dated March 6, 2025, and the agency has not said whether the entry will lead to a label change, a safety communication or no action [1]. Until the FDA publishes something further, the current labels stand.
Sources
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