Blinded by the drug? A vigilyze signal linking semaglutide to NAION.

Abstract

Introduction: Semaglutide, available widely as Ozempic, Wegovy, and Rybelsus, has significantly improved the management of type 2 diabetes and obesity due to its beneficial adverse drug reactions and safer use in diverse population. However, as its use grows widely, rare but serious side effects are coming to light. One such emerging concern is Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), a condition causing sudden, often irreversible vision loss.

Methodology: A retrospective, post-market observational study was conducted using data collected from VigiBase® until June 2025, using mapped terms under Medical Dictionary for Regulatory Activities (MedDRA).

Result: Of 73,636 global Individual Case Safety Reports (ICSRs) related to Semaglutide reported adverse reactions globally, 91 were associated with the adverse reaction NAION. The cases were reported globally with increased number of cases reported by Denmark (N = 38, 41.80%), Australia (N = 9, 9.90%) and France (N = 7, 7.70%), primarily affected patients aged 45-74 years (N = 50, 54.90%). Most cases (97.80%) were classified as serious with a significant of the cases reported of males. The co-reported reactions involved serious 'eye-related' conditions like Visual Impairment (N = 12,13.20%), Blindness (N = 9, 9.90%), Visual field defect (N = 5, 5.50%), Optic atrophy (N = 4, 4.40%), Vision blurred (N = 4, 4.40%) among other serious reactions.

Conclusion: This study raises awareness of a rare yet significant safety concern with Semaglutide. Early detection of NAION symptoms and timely drug discontinuation may be critical in preventing permanent vision loss. Moreover, the reaction should be mentioned in the patient information leaflet/ summary of the product characteristic of the drug to create awareness among the healthcare providers as well as the consumers taking the drug.