FDA Data Suggests Possible Link Between Semaglutide and a Rare Eye Condition | Research

The takeaway

Disproportionality analysis of FDA adverse event data found a reporting signal for semaglutide and nonarteritic anterior ischemic optic neuropathy (NAION).

Signal detected
Disproportionate NAION reporting for semaglutide vs other diabetes drugs in FDA data

What the researchers found

Semaglutide showed a disproportionate reporting signal for NAION in FDA adverse event data, even after controlling for diabetes as a confounding indication.

Why it matters

NAION causes sudden, often permanent vision loss — if semaglutide increases this risk, millions of users need to be informed.

The numbers in context

96 NAION cases total; 83 with semaglutide; ROR 17.57 (95% CI 13.93-21.90); median onset 186 days; 53 cases in last 3 months; 18 from Denmark.

How the study worked

Pharmacovigilance disproportionality analysis of FAERS data with active-comparator restricted design and therapeutic area analysis.

Who was studied

Patients reporting NAION while on GLP-1 RAs (FAERS database)

What this study cannot tell us

Spontaneous reporting data — cannot establish causation, true incidence, or mechanism. Reporting bias possible due to media attention.

How to read the evidence

Pharmacovigilance signal — flags a potential association but cannot confirm causation. Requires epidemiological follow-up.

When this study was published

Published in 2025, responding to EMA review initiated in January 2025.

The bigger picture

This adds to the growing pharmacovigilance effort as GLP-1 drug use expands — even rare events become significant at the population level.

Questions still open

Is the NAION risk specific to semaglutide or shared across GLP-1 drugs?
What is the absolute risk of NAION in semaglutide users?

Common questions

Can semaglutide cause vision problems?

FDA data shows a reporting signal for NAION (sudden vision loss), but a causal link has not been confirmed. Report any sudden vision changes to your doctor.

What is NAION?

Nonarteritic anterior ischemic optic neuropathy — a condition where blood flow to the optic nerve is disrupted, causing sudden partial vision loss.

Read the original research

Disproportionality analysis on semaglutide and nonarteritic anterior ischemic optic neuropathy in the FDA adverse event reporting system: An emerging pharmacovigilance signal?

Obesity research & clinical practice, 19(2), 178-180

View on PubMed ↗Publisher’s paper ↗

Citation

Procacci, Angela; Poluzzi, Elisabetta; De Ponti, Fabrizio; Raschi, Emanuel. (2025). Disproportionality analysis on semaglutide and nonarteritic anterior ischemic optic neuropathy in the FDA adverse event reporting system: An emerging pharmacovigilance signal?. Obesity research & clinical practice, 19(2), 178-180. https://doi.org/10.1016/j.orcp.2025.03.001