The U.S. Food and Drug Administration (FDA) is requiring manufacturers of glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications to update their product labels to warn about a potential increased risk of a rare eye condition that can cause permanent vision loss.
The agency announced the decision Nov. 9, following an evaluation of clinical trial data, animal studies, observational research and reports of adverse events involving the medications.
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The condition, known as non-arteritic anterior ischemic optic neuropathy (NAION), occurs when blood flow to the optic disc, the front portion of the optic nerve, decreases. It can cause sudden, painless vision loss in one eye, including permanent impairment.
The FDA is requiring manufacturers of all GLP-1 RA medications to include information about the potential risk in the Warnings and Precautions section of their labeling.
The affected drug class includes medications such as Novo Nordisk’s Ozempic and Wegovy, Eli Lilly’s Mounjaro and Zepbound, and other approved treatments used for Type 2 diabetes and weight management including Ozempic. Mounjaro and Zepbound are dual GIP and GLP-1 receptor agonists.
To assess the potential association, the FDA conducted a meta-analysis of 126 randomized controlled clinical trials involving 134,253 participants and of the 15 probable NAION cases identified, 10 occurred among patients receiving GLP-1 medications and five among those in comparator groups.
The analysis found an incidence rate of 6.4 cases per 100,000 person-years among patients taking GLP-1 medications, compared with 3.8 cases per 100,000 person-years among those receiving a placebo or other glucose-lowering medications.
The agency also examined real-world data involving adults with Type 2 diabetes who started GLP-1 medications or other diabetes treatments between 2019 and 2024.
That analysis found no statistically significant increase in NAION risk when GLP-1 medications were compared with SGLT-2 inhibitors.
However, an increased risk was observed when they were compared with DPP-4 inhibitors.
The FDA said published observational studies with more rigorous methodologies had consistently reported an increased risk among patients with Type 2 diabetes who started GLP-1 medications compared with those starting either of the two alternative drug classes.
The agency also reviewed the available animal data but did not identify a mechanism explaining how GLP-1 medications might increase the risk of NAION.
A July 2024 study published in JAMA Ophthalmology had previously reported an association between semaglutide, the active ingredient in Ozempic and Wegovy, and NAION.
However, the observational findings did not establish that the medication caused the condition.
The FDA said patients experiencing sudden, painless vision loss, blind spots, blurred vision, distorted colors or other visual disturbances in one eye should contact their health care professional immediately.
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Patients diagnosed with NAION should discuss whether to continue or discontinue their medication with their doctors.
The agency advises health care professionals to consider stopping GLP-1 treatment in affected patients unless the benefits clearly outweigh the risks.
The FDA said NAION is rare, but the potential risk warrants updated warnings across the drug class.