Cited by 114Pharmacovigilance and Adverse Drug ReactionsSuicide and Self-Harm StudiesPharmacology and Obesity Treatment

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Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality

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Schoretsanitis, Georgios, Weiler, Stefan, Barbui, Corrado, Raschi, Emanuel, Gastaldon, Chiara·2024·JAMA Network Open

DOI 10.1001/jamanetworkopen.2024.23385PMC PMC11337067

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Abstract

Importance: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have gained use primarily due to their weight-reduction effects, although a regulatory review was undertaken for potential suicidality concern. Objectives: To evaluate potential signals for suicidal and self-injurious adverse drug reactions (ADRs) associated with the GLP-1 RAs semaglutide and liraglutide. Design, Setting, and Participants: Disproportionality analysis through the case-control design using the World Health Organization (WHO) global database of suspected ADRs. Participants were clinical patients worldwide experiencing an ADR suspectedly attributable to semaglutide or liraglutide in the database from inception to August 30, 2023. Data were analyzed from September to December 2023. Exposure: Treatment with semaglutide or liraglutide regardless of indication or treatment duration. Main Outcomes and Measures: Reporting odds ratio (ROR) and the bayesian information component (IC) with 95% CIs were calculated as measures of disproportionate reporting of suicidal and self-injurious ADRs associated with semaglutide and liraglutide compared with all other medications. Sensitivity analyses were conducted including patients with coreported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators. A disproportionality signal was considered when the lower limits of the ROR and IC were above 1 and 0, respectively. Results: A total of 107 (median [IQR] age 48 [40-56] years; 59 female patients [55%]) and 162 (median [IQR] age 47 [38-60] years; 100 female patients [61%]) cases of suicidal and/or self-injurious ADRs were reported between November 2000 and August 2023 with semaglutide and liraglutide, respectively. Significant disproportionality was detected only for semaglutide-associated suicidal ideation (ROR, 1.45; 95% CI, 1.18-1.77; IC, 0.53; 95% CI, 0.19-0.78), which remained significant in patients with coreported use of antidepressants (ROR, 4.45; 95% CI, 2.52-7.86; IC, 1.96; 95% CI, 0.98-2.63) and benzodiazepines (ROR, 4.07; 95% CI, 1.69-9.82; IC, 1.67; 95% CI, 0.11-2.65), when compared with dapagliflozin (ROR, 5.56; 95% CI, 3.23-9.60; IC, 0.70; 95% CI, 0.36-0.95), metformin (ROR, 3.86; 95% CI, 2.91-5.12; IC, 1.20; 95% CI, 0.94-1.53) and orlistat (ROR, 4.24; 95% CI, 2.69-6.69; IC, 0.70; 95% CI, 0.36-0.95). Conclusions and Relevance: This study using the WHO database found a signal of semaglutide-associated suicidal ideation, which warrants urgent clarification.

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Authors: Schoretsanitis, G., Weiler, S., Barbui, C., Raschi, E., & Gastaldon, C.
Affiliations: Northwell Health (US)
University of Zurich (CH)
University of Verona (IT)
University of Bologna (IT)
University of Bern (CH)
Corresponding author: Schoretsanitis, Georgios
ORCID: Schoretsanitis, Georgios
Weiler, Stefan
Barbui, Corrado
Raschi, Emanuel
Gastaldon, Chiara
Venue: JAMA Network Open
Publisher: American Medical Association (AMA)
Published: 2024-08-20
Volume: 7
Issue: 8
Pages: e2423385
ISSN: 2574-3805 (ISSN-L)
DOI: 10.1001/jamanetworkopen.2024.23385
PMC: PMC11337067
OpenAlex: W4401715897
Cited by: 107
References: 35
Citations by year: 2026: 45 · 2025: 53 · 2024: 9
FWCI: 25.46
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
Locations: JAMA Network Open (publishedVersion, cc-by)
PubMed (publishedVersion)
PubMed Central (publishedVersion, cc-by)
Bern Open Repository and Information System (University of Bern) (submittedVersion, cc-by)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, cc-by)
Repository for Publications and Research Data (ETH Zurich) (submittedVersion, cc-by)
Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by)
ETH Zürich Research Collection (cc-by)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
Keywords: semaglutide, liraglutide, GLP-1 receptor agonists, suicidality, self-harm, suicidal ideation, adverse drug reactions, disproportionality analysis, drug safety, anti-obesity drugs, reporting odds ratio, dapagliflozin
MeSH terms: Liraglutide, Semaglutide, Adult, Glucagon-Like Peptides, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, Suicide, World Health Organization, Case-Control Studies, Self-Injurious Behavior

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Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality

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