Evidence map›Paper›PMID 41739406›Full record

ArticleInternational journal of clinical pharmacy2026

Comparative pharmacovigilance analysis of suicidality-related adverse events among GLP-1 and non-GLP-1 anti-obesity drugs in the FDA Adverse Event Reporting System.

Jose Seijas-Amigo, Ángel Salgado-Barreira, Diego Rodriguez-Penas, Begoña Cardeso-Paredes, Marta Ribeiro-Ferreiro, Moisés Rodriguez-Mañero, Jose Ramon Gonzalez-Juanatey

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical pharmacy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jose Seijas-AmigoCardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Santiago de Compostela, Spain.ORCID http://orcid.org/0000-0002-5625-2771
Ángel Salgado-BarreiraDepartment of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain. angel.salgado.barreira@usc.es.
Diego Rodriguez-PenasCardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Santiago de Compostela, Spain.
Begoña Cardeso-ParedesCardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Santiago de Compostela, Spain.
Marta Ribeiro-FerreiroCardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Santiago de Compostela, Spain.
Moisés Rodriguez-MañeroCardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Santiago de Compostela, Spain.
Jose Ramon Gonzalez-JuanateyCentro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRegulatory reviews in 2023-2024 reignited concern about possible suicidality with Glucagon-like peptide-1 (GLP-1) receptor agonists used for weight management. While clinical trials and real-world studies have not confirmed an increased risk, comparative post-marketing analyses across all anti-obesity agents are scarce.

aimTo compare disproportional reporting of suicidality-related adverse events among GLP-1/dual incretin versus non-GLP-1 anti-obesity drugs in the FDA Adverse Event Reporting System (FAERS).

methodWe conducted a retrospective disproportionality study using FAERS (January 2012-February 2025). Reports submitted from the United States with the study drug listed as primary suspect were retrieved via openFDA. Suicidality terms were predefined (MedDRA Preferred Terms: suicidal ideation, suicide attempt, completed suicide). Reporting Odds Ratios (RORs) with 95% confidence intervals (CIs) were calculated for each drug and at class level (GLP-1/dual incretin vs non-GLP-1). Haldane-Anscombe corrections were applied where needed.

resultsAmong approximately 78,000 anti-obesity reports, 207 (approximately 0.3%) involved suicidality-related events. For semaglutide, RORs were 1.39 (95% CI 0.99-1.94) for suicidal ideation, 1.38 (0.46-4.15) for suicide attempt, and 1.72 (0.62-4.74) for completed suicide, none statistically significant. Liraglutide showed ROR 1.01 (0.66-1.55) for suicidal ideation and 18.11 (6.96-47.15) for completed suicide based on 14 cases. Tirzepatide yielded RORs below unity for all outcomes. Naltrexone/bupropion showed elevated disproportional reporting for suicidal ideation (ROR 3.84; 95% CI 2.89-5.12) and suicide attempt (ROR 4.11; 95% CI 1.62-10.45.

conclusionGLP-1 and dual-incretin agents did not show disproportionality signals for suicidal ideation or suicide attempt. A statistically significant disproportionality signal for completed suicide was observed for liraglutide; however, this estimate was based on few cases and displayed wide confidence intervals, warranting cautious interpretation. These findings support an overall neutral psychiatric safety profile for incretin-based therapies while underscoring the need for continued monitoring of rare events such as completed suicide.

Indexed as

Adverse Drug Reaction Reporting SystemsAnti-Obesity AgentsPharmacovigilanceSuicideAdultExenatideFemaleGlucagon-Like Peptide-1 Receptor AgonistsHumansLiraglutideMaleMiddle AgedRetrospective StudiesSemaglutideSuicidal IdeationTirzepatideAnti-Obesity AgentsExenatideGlucagon-Like Peptide-1 Receptor AgonistsLiraglutideSemaglutideTirzepatideAdverse drug reactionsAnti-obesity drugsFAERSGLP-1 receptor agonistsPharmacovigilanceSuicidality

Identifiers

PMID41739406
PMCPMC13176177

What Socratic holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.