Citation

McIntyre RS, Mansur RB, Rosenblat JD, Kwan ATH. Expert Opin. Drug Saf. 2024; 23(1): 47-55.

Copyright

(Copyright © 2024, Informa Healthcare)

DOI

10.1080/14740338.2023.2295397

PMID

38087976

Abstract

INTRODUCTION: Recently, the European Medicines Agency (EMA) received reports of suicidal thoughts and self-injury associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) liraglutide and semaglutide.
RESEARCH DESIGN AND METHODS: Herein, we sought to evaluate suicidality associated with all GLP-1 RAs relative to other glucose-lowering agents currently approved by the United States Food and Drug Administration (FDA). Reports of suicidal ideation, "depression/suicidal", suicidal behavior, suicidal attempts, and completed suicide associated with GLP-1 RA exposure reported to the FDA between 2005 and October 2023 were obtained from the FDA Adverse Event Reporting System (FAERS). We present data using the reporting odds ratio (ROR). The ROR was considered significant when the lower limit of the 95% confidence interval (CI) was greater than 1.0.
RESULTS: Disproportionate reporting of suicidal ideation and "depression/suicidal" was observed with semaglutide and liraglutide. Disproportionate reporting of suicidal behavior, suicide attempts, and completed suicide was not observed for any of the FDA-approved GLP-1 RAs.
CONCLUSIONS: Using the Bradford Hill criteria, however, and taking into consideration confounders, no causal link between GLP-1 RAs and suicidality exists.

Language: en

Keywords

Diabetes Mellitus, Type 2; Dulaglutide; Exenatide; Glucagon-Like Peptide 1; Glucagon-like peptide 1 (GLP-1); Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide-1 Receptor Agonists; Glucagon-Like Peptides; Humans; Hypoglycemic Agents; liraglutide; Liraglutide; lixisenatide; semaglutide; Suicidal Ideation; suicide; Suicide; tirzepatide; United States; United States Food and Drug Administration