Global VigiBase analysis confirms 91 cases of semaglutide-associated NAION with 97.8% classified as serious | Research

The takeaway

VigiBase analysis found 91 cases of NAION (non-arteritic anterior ischemic optic neuropathy) among 73,636 semaglutide adverse event reports globally, with 97.8% classified as serious and co-reported conditions including visual impairment, blindness, and optic atrophy.

91 NAION cases globally
97.8% were serious, including blindness (9.9%) and optic atrophy (4.4%)—supporting addition of NAION to semaglutide safety information

What the researchers found

91 NAION cases among 73,636 semaglutide reports. 97.8% serious. Denmark: 38 cases (41.8%). Age 45-74: 54.9%. Male predominance. Co-reported: visual impairment 13.2%, blindness 9.9%, optic atrophy 4.4%, visual field defect 5.5%.

Why it matters

With 91 globally reported cases and nearly all classified as serious, this confirms NAION as a rare but significant safety concern with semaglutide. The call for label updates reflects the severity—NAION causes irreversible vision loss.

How the study worked

Retrospective post-market analysis of VigiBase (WHO global ICSR database) through June 2025. MedDRA terminology mapping. Descriptive analysis of NAION cases.

What this study cannot tell us

ICSR data: spontaneous reporting with inherent biases. Cannot calculate incidence (no denominator). Denmark overrepresented (may reflect reporting culture). Causation not established.

How to read the evidence

Global pharmacovigilance analysis from WHO database. Confirms safety signal but cannot establish causation or incidence.

When this study was published

Published in 2025; VigiBase through June 2025.

The bigger picture

This global pharmacovigilance data from VigiBase complements the Danish-Norwegian registry study, providing worldwide confirmation of the semaglutide-NAION safety signal from a different data source.

Questions still open

Should NAION be added to semaglutide prescribing information?
Is Denmark's high reporting due to better surveillance or higher risk?
Should eye exams be recommended before starting semaglutide?

Common questions

How many people have gone blind from semaglutide?

This global analysis found 91 reported cases of NAION (sudden optic nerve damage) among semaglutide users worldwide, with about 10% reporting blindness and 4% optic atrophy. While this is very rare relative to millions of users, nearly all cases (97.8%) were classified as serious, and the vision loss is often permanent.

Should NAION be on semaglutide warning labels?

The study authors recommend adding NAION to patient information leaflets and prescribing information. With 91 globally confirmed cases—mostly serious with irreversible vision loss—transparency about this risk allows patients and doctors to make informed decisions and recognize symptoms early.

Read the original research

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

International ophthalmology, 45(1), 398

View on PubMed ↗Publisher’s paper ↗

Citation

Suresh, Jaishree; Vivekanandan, Kalaiselvan. (2025). Blinded by the drug? A vigilyze signal linking semaglutide to NAION.. International ophthalmology, 45(1), 398. https://doi.org/10.1007/s10792-025-03760-7