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

Mar 25, 2025Obesity research & clinical practice

Possible link between semaglutide and sudden optic nerve damage in FDA safety reports

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Abstract

A total of 96 cases of Nonarteritic Anterior Ischemic Optic Neuropathy were identified, with 83 cases linked to semaglutide.

The number of NAION cases peaked at 53 in the last three months of the study period.
The median time to onset of NAION after starting treatment with semaglutide was 186 days.
A significant signal of disproportionate reporting for NAION was found exclusively for semaglutide, with a Reporting Odds Ratio of 17.57.
The signal remained consistent when compared against other antidiabetic and antiobesity medications, including SGLT2 inhibitors.
An increasing trend in NAION case reporting suggests the need for further investigation into potential risk factors associated with semaglutide.

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BACKGROUND AND AIM: On January 17th 2025, the European Medicines Agency started a review on semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy (NAION); we gained insight into this potential association by appraising post-marketing reporting.

METHODS: We queried the FDA Adverse Event Reporting System (up to December 2024) to retrieve cases of NAION reported with GLP-1 receptor agonists. Disproportionality analysis was performed by calculating the Reporting Odds Ratio (ROR) with 95 % confidence Interval (CI). Signal of Disproportionate Reporting (SDR) was defined by a lower limit of the 95 %CI> 1. To account for potential confounding by indication and channeling bias, active-comparator restricted design and disproportionality by therapeutic area were performed by comparing semaglutide vs other antidiabetic/antiobesity drugs, including SGLT2-inhibitors.

RESULTS: 96 NAION cases were retrieved (83 to semaglutide), peaking 53 in last 3 months (18 from Denmark), with a median time to onset of 186 days. An SDR emerged only for semaglutide (ROR=17.57; 95 %CI=13.93-21.90), and remained significant across comparators and therapeutic indications.

CONCLUSIONS: Notwithstanding limitations, including inability to infer causality, the consistency of disproportionality against a wide range of confounders together with other observational evidence raised the hypothesis of a safety signal, especially from Denmark. The exponential reporting trend calls for urgent clarification of drug-, patient- and Country-related risk factors.

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

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