The US Food and Drug Administration (FDA) has warned of a potential association between glucagon-like peptide-1 (GLP-1) receptor agonists and nonarteritic anterior ischemic optic neuropathy (NAION), requiring updated warning labels across the drug class.
Affected medications include Novo Nordisk’s semaglutide, Eli Lilly’s tirzepatide and Sanofi’s insulin glargine/lixisenatide, shares the FDA. The federal agency explains that NAION is a rare condition caused by reduced blood flow to the optic nerve, resulting in sudden, painless vision loss in one eye, which may be permanent.
The FDA shares it began investigating the potential association following a 2024 study, published in JAMA Ophthalmology, which reported an increased risk of NAION among GLP-1 users. Despite noting limitations in the study, the agency determined that further investigation was warranted. The FDA subsequently reviewed 126 clinical trials involving more than 134,200 patients, identifying 15 probable NAION cases; 10 among GLP-1 users, five among placebo recipients and none among patients receiving non-GLP-1 glucose-lowering medications.
The estimated incidence was 6.4 cases per 100,000 person-years among GLP-1 users, compared with 3.8 cases among placebo recipients and patients receiving alternative glucose-lowering treatments.
A spokesperson from the FDA commented, “NAION cases have been reported for all currently marketed GLP-1 RA products. The FDA concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 receptor agonists. Based on these findings, the FDA is requiring that application holders add information about the risk for NAION to the Warnings and Precautions section of labelling of all GLP-1 receptor agonists.”