In the United States, the Food and Drug Administration (FDA) has ordered that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) carry warning labels for a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION).1
Announcing the decision, the FDA said NAION cases have been reported for all currently marketed GLP-1 RA products.
“Data from an analysis of 126 randomised, controlled clinical trials across multiple GLP-1 RAs showed an occurrence of 6.4 NAION cases per 100,000 person-years (PY) in patients treated with GLP-1 RAs compared to 3.8 NAION cases per 100,000 PY for patients treated with a placebo or a non-GLP-1 RA glucose-lowering medication.
That compares to an incidence in the general population of between 2.3 to 10.2 cases per 100,000 persons per year in adults older than age 50, the FDA said.
Announcing the decision, the FDA said NAION cases have been reported for all currently marketed GLP-1 RA products.
Patients with a history of NAION are at increased risk of recurrence.
In June 2025. the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 users, and recommended that product information be updated accordingly.2
While the European review was limited to semaglutide, the US labelling change is classwide, from liraglutide (Victoza, Saxenda), dulaglutide (Trulicity) and exenatide to the dual GIP/GLP-1 agonist tirzepatide (Mounjaro, Zepbound; Eli Lilly) and the oral small-molecule agent orforglipron (Foundayo), approved in the US earlier this year.
In September this year (2026), the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) issued a statement acknowledging the potential association between GLP-1 RAs and NAION but emphasised that causation had not been established. At that time RANZCO said it “did not recommend routinely stopping GLP-1 agents based on current evidence. Patients with prior NAION, marked optic-disc crowding, or multiple vascular risk factors may be at higher risk for fellow-eye involvement and should be discussed individually.”3
References
- US Food and Drug Administration. FDA requires safety labeling changes for glucagon-like peptide-1 receptor agonists (GLP-1 RAs) due to potential risk of non-arteritic anterior ischemic optic neuropathy (NAION). Drug Safety Communication. Available at: fda.gov/drugs/drug-safety-communications/fda-requires-safety-labeling-changes-glucagon-peptide-1-receptor-agonists-glp-1-ras-due-potential [accessed 11 Nov 2026].
- European Medicines Agency. PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines Ozempic, Rybelsus and Wegovy. News release. 6 June 2025, updated 13 June 2025. Available at: ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy [accessed 11 Nov 2026].
- Cheng, Yen. GLP-1 RAs and NAION: What optometrists need to know right now. Mivision. Available at mivision.com.au/2026/09/glp-1-ras-and-naion-what-optometrists-need-to-know-right-now/ [accessed 12 Nov 2026].