Semaglutide: Nonarteritic Anterior Ischemic Optic Neuropathy in the FDA adverse event reporting system – A disproportionality analysis

Feb 8, 2025Obesity research & clinical practice

Reports of a rare optic nerve injury linked to Semaglutide in FDA safety data

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Abstract

Semaglutide is associated with a significant reporting signal for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) based on analysis of the FDA Adverse Event Reporting System.

A disproportionality analysis of FAERS data indicates a stronger association between semaglutide and NAION compared to other GLP-1 receptor agonists.
Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR) were calculated to assess the association with adverse events.
The analysis covers adverse events reported from January 1, 2004, to September 30, 2024.
The mechanisms behind the association with NAION are not fully understood but may involve impacts on the hypothalamus and vascular health.
Further research is necessary to confirm these findings and ensure the safe use of semaglutide.

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Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is used for type 2 diabetes (T2D) and approved for obesity by the FDA in 2022 and in Europe in 2023. Its increasing use has raised concerns about access for T2D patients and potential adverse events (AE), such as Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). This study investigates the association between semaglutide and these AE using the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using FAERS data. AE were identified using MedDRA Preferred Terms (PTs) and related terms. OpenVigil 2.1 was used for data extraction and analysis. This system is a spontaneous safety surveillance database for drugs. The participants are patients who reported AE related to GLP-1 receptor agonists in the FAERS database from January 1, 2004, to September 30, 2024. Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR) were calculated to assess the association between GLP-1 receptor agonists and the AE. Semaglutide showed a significant ROR and PRR for NAION, suggesting a stronger association compared to other GLP-1 receptor agonists. The findings suggest a disproportionate reporting signal for semaglutide and NAION. The mechanisms behind these associations are not fully understood but may involve effects on the hypothalamus and vascular health. Further research is necessary to confirm these findings ensure the safe use of semaglutide, given the potential risk associated with this rare but severe adverse event.

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Semaglutide: Nonarteritic Anterior Ischemic Optic Neuropathy in the FDA adverse event reporting system – A disproportionality analysis

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