Ischemic optic neuropathy with semaglutide: global observational analysis of sex- and formulation-specific risk.

The British journal of ophthalmology2026PMID: 41807083

View on PubMed DOI: 10.1136/bjo-2025-328483

Plain Language Summary

FAERS global pharmacovigilance analysis of ischemic optic neuropathy (ION) risk across 31,774 semaglutide reports (2017–2024), stratified by formulation (Wegovy versus Ozempic) and sex. Wegovy demonstrated a substantially stronger ION signal (ROR=74.89) versus Ozempic (ROR=18.81); sex-stratified analyses revealed differential ION risk between males and females. Documents formulation-specific ION risk differences between obesity-dose and diabetes-dose semaglutide—potentially implicating higher semaglutide exposure in obesity dosing as a risk factor for this rare but vision-threatening complication.

Abstract

Ischaemic optic neuropathy (ION) is a rare but vision-threatening complication recently linked to GLP-1 receptor agonists, particularly semaglutide. Using over 30 million reports from the FDA Adverse Event Reporting System (2017-2024), we evaluated formulation- and sex-specific associations. Among 31 774 semaglutide cases, Wegovy demonstrated the strongest signal for ION (reporting odds ratio (ROR)=74.89) compared with Ozempic (ROR=18.81). Sex-stratified analyses showed higher odds in men (ROR=116.37), and multivariable regression confirmed greater risk with Wegovy versus Ozempic (adjusted OR (AOR)=4.74) and in men versus women (AOR=3.33). These findings highlight a potential dose-dependent safety concern that warrants urgent prospective evaluation to guide prescribing and regulatory policy.

Authors

Lakhani, Moiz; Al-Ani, Abdullah; Popovic, Marko; Bénard-Séguin, Étienne; Margolin, Edward

Keywords

DrugsOptic NervePharmacologyPublic healthVision