TY - JOUR
T1 - Exploring the Association Between Suicidal Thoughts, Self-Injury, and GLP-1 Receptor Agonists in Weight Loss Treatments: Insights from Pharmacovigilance Measures and Unmasking Analysis
AU - Guirguis, Amira
AU - Chiappini, Stephania
AU - Papanti, P G Duccio
AU - Vickers-Smith, Rachel
AU - Harris, Daniel
AU - Corkery, John
AU - Arillotta, Davide
AU - Floresta, Giuseppe
AU - Martinotti, Giovanni
AU - Schifano, Fabrizio
N1 - © 2024 The Authors. Published by Elsevier B.V. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/
PY - 2024/5
Y1 - 2024/5
N2 - Introduction: The study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA). Aim: The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators. Methods: Descriptive and pharmacovigilance disproportionality analyses was performed. Results: A total of 209,354 ADRs were reported, including 59,300 serious cases. Of those, a total of 5378 psychiatric disorder cases, including 383 ‘serious’ cases related to selected ADRs were registered during 2005–2023. After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64), exenatide (n = 67; ROR = 0.80), semaglutide (n = 61; ROR = 2.03), dulaglutide (n = 45; ROR = 0.84), tirzepatide (n = 5; ROR = 1.76) and albiglutide (n = 2; ROR = 0.04). A greater association between these ADRs with metformin was observed, but not orlistat. With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded. Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide). Discussion: Suicide/self-injury reports pertaining to semaglutide; tirzepatide; and liraglutide were characterised, although lower than metformin. It is postulated that rapid weight loss achieved with GLP-1 RA can trigger significant emotional, biological, and psychological responses, hence possibly impacting on suicidal and self-injurious ideations. Conclusions: With the current pharmacovigilance approach, no causality link between suicidal ideation and use of any GLP-1 RA can be inferred. There is a need for further research and vigilance in GLP-1 RA prescribing, particularly in patients with co-existing psychiatric disorders.
AB - Introduction: The study addresses concerns about potential psychiatric side effects of Glucagon-like peptide-1 receptor agonists (GLP-1 RA). Aim: The aim of this work was to analyse adverse drug reports (ADRs) from the Food and Drug Administration Adverse Events Reporting System (FAERS) using metformin and orlistat as comparators. Methods: Descriptive and pharmacovigilance disproportionality analyses was performed. Results: A total of 209,354 ADRs were reported, including 59,300 serious cases. Of those, a total of 5378 psychiatric disorder cases, including 383 ‘serious’ cases related to selected ADRs were registered during 2005–2023. After unmasking, 271 cases where individual GLP-1 RA were implicated showing liraglutide (n = 90; Reported Odds Ratio (ROR) = 1.64), exenatide (n = 67; ROR = 0.80), semaglutide (n = 61; ROR = 2.03), dulaglutide (n = 45; ROR = 0.84), tirzepatide (n = 5; ROR = 1.76) and albiglutide (n = 2; ROR = 0.04). A greater association between these ADRs with metformin was observed, but not orlistat. With regards to selected preferred terms (PTs), 42 deaths including 13 completed suicides were recorded. Suicidal ideation was recorded in n = 236 cases for 6/7 GLP-1 RA (excluding lixisenatide). Discussion: Suicide/self-injury reports pertaining to semaglutide; tirzepatide; and liraglutide were characterised, although lower than metformin. It is postulated that rapid weight loss achieved with GLP-1 RA can trigger significant emotional, biological, and psychological responses, hence possibly impacting on suicidal and self-injurious ideations. Conclusions: With the current pharmacovigilance approach, no causality link between suicidal ideation and use of any GLP-1 RA can be inferred. There is a need for further research and vigilance in GLP-1 RA prescribing, particularly in patients with co-existing psychiatric disorders.
KW - pharmacovigilance
KW - Glucagon-like peptide-1 receptor agonists
KW - adverse drug reactions
KW - suicide
KW - Adverse drug reactions
KW - Pharmacovigilance
KW - Suicide
UR - http://www.scopus.com/inward/record.url?scp=85188667039&partnerID=8YFLogxK
U2 - 10.1016/j.euroneuro.2024.02.003
DO - 10.1016/j.euroneuro.2024.02.003
M3 - Article
SN - 0924-977X
VL - 82
SP - 82
EP - 91
JO - European Neuropsychopharmacology
JF - European Neuropsychopharmacology
ER -