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 - PubMed
4 hours ago
- #pharmacovigilance
- #GLP-1
- #suicidality
- Regulatory reviews in 2023-2024 raised concerns about suicidality risks with GLP-1 receptor agonists used for weight management.
- A comparative pharmacovigilance study analyzed suicidality-related adverse events in GLP-1 and non-GLP-1 anti-obesity drugs using FDA FAERS data.
- Among approximately 78,000 anti-obesity reports, 207 (0.3%) involved suicidality-related events.
- Semaglutide showed no statistically significant increased risk for suicidal ideation, suicide attempt, or completed suicide.
- Liraglutide had a significant disproportionality signal for completed suicide (ROR 18.11), but this was based on only 14 cases.
- Tirzepatide showed no increased risk for any suicidality-related outcomes.
- Naltrexone/bupropion had elevated disproportional reporting for suicidal ideation (ROR 3.84) and suicide attempt (ROR 4.11).
- The study concluded that GLP-1 and dual-incretin agents generally have a neutral psychiatric safety profile, but rare events like completed suicide require continued monitoring.