Type 2 & other diabetes

Association between glucagon‐like peptide ‐1 receptor agonists and risk of suicidality: A comprehensive analysis of the global pharmacovigilance database

Diabetes Obes MetabPublished Pharmacovigilance study

Authors' conclusion

The suspected association between GLP-1RA use and suicidality, as raised by the European Medicines Agency, was not found in our global analysis. This indicates that the sporadic reports of GLP-1RA-associated suicidality are likely influenced by factors such as comorbidities present in the GLP-1RA user population.

Study context

Population
Adverse drug reaction reports in the WHO pharmacovigilance database, 1967–2023, 170 countriestotal reports
Participants
131,255,418 reports
Exposure
GLP-1 RA use vs other drugs, for suicidality reports
Outcome
Suicidality reports associated with GLP-1RA use (ROR with 95% CI; IC with IC025)
Methodological detailsdisproportionality analysis, WHO global pharmacovigilance database, adverse drug reaction reports 1967–2023, 170 countries
  • Disproportionality analysis
  • WHO global pharmacovigilance database
  • Adverse drug reaction reports 1967–2023
  • 170 countries

Main finding

As reported in the abstract

Suicidality with GLP-1RAs
GroupValueRORInformation component (IC)
GLP-1RAs332 events0.15 (95% CI 0.13 to 0.16)−2.77 (IC025 −2.95)

GLP-1RAs

Value332 events
ROR0.15 (95% CI 0.13 to 0.16)
Information component (IC)−2.77 (IC025 −2.95)

Observational data: associations, not effects.

Further findings

Suicidality with GLP-1RAs used for diabetes
0.13 (95% CI 0.11 to 0.14) · ROR · IC −2.95 (IC025 −3.14)
Suicidality with GLP-1RAs used for obesity
0.44 (95% CI 0.34 to 0.58) · ROR · IC −1.16 (IC025 −1.62)
Suicidality with other diabetes medications
1.13 (95% CI 1.10 to 1.15) · ROR · IC 0.17 (IC025 0.13)
Suicidality with other obesity medications
1.08 (95% CI 1.01 to 1.14) · ROR · IC 0.10 (IC025 0.01)

Suicidality with other diabetes medications

Association found

Suicidality with other obesity medications

Potential association observed

Original publication

Association between glucagon‐like peptide ‐1 receptor agonists and risk of suicidality: A comprehensive analysis of the global pharmacovigilance database. Diabetes Obes Metab. Published 19 August 2024. doi:10.1111/dom.15864

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