Current FDA Safety Investigation: NAION With Mounjaro, Zepbound, and Other GLP-1 RAs

Evaluating Glucagon-like Peptide-1 (GLP-1) Receptor Agonists for Possible Risk of NAION Side Effects

 

(Posted by Tom Lamb at Drug Injury Watch)

 

The FDA has been investigating "potential signals" of non-arteritic anterior ischemic optic neuropathy (NAION) with the glucagon-like peptide-1 (GLP-1) receptor agonist class of drugs. For example, NAION with Mounjaro, Zepbound, Wegovy, Rybelsus, and Ozempic.

From "October – December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)", here is a full list of the glucagon-like peptide-1 (GLP-1) receptor agonists, or GLP-1 RAs, that are being evaluated:

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
Zepbound (tirzepatide) injection

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Mounjaro / Zepbound

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In early June 2025, the European Medicines Agency (EMA) confirmed the link between the semaglutide-containing drugs Wegovy, Rybelsus, and Ozempic and NAION (non-arteritic anterior ischemic optic neuropathy). This drug regulator went on to say a NAION warning would be added to the drug labels for Wegovy, Rybelsus, and Ozempic in Europe.

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Ozempic / Wegovy / Rybelsus

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We have posted several articles on Drug Injury Watch during the past year about NAION linked to Ozempic, Rybelsus, and Wegovy:

As seen in those articles, the link between the semaglutide-containing drugs and NAION is fairly well-established by this point in time.

This is our first consideration of NAION with Mounjaro, Zepbound, and other GLP-1 RAs besides Wegovy, Rybelsus, and Ozempic.

We will monitor the FDA, the EMA, and other drug regulators, as well as the relevant medical literature, for developments concerning a possible association of NAION with the tirzepatide-containing drugs Mounjaro and Zepbound as well as those various drugs with the active ingredients dulaglutide, exenatide, liraglutide, and lixisenatide (see the above list for brand-name information).

If you have developed NAION with Mounjaro, Zepbound, or other GLP-1 RAs — including Wegovy, Rybelsus, and Ozempic — there might be a drug injury lawsuit against the responsible pharmaceutical company. Please don't hesitate to contact us if you are interested in such a case.

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