| アブストラクト | INTRODUCTION: Glucagon-like peptide-1 (GLP-1) and GIP receptor agonists (RAs) are increasingly used for treating type 2 diabetes mellitus and for chronic weight management. As their use expands, more attention is being paid to potential safety concerns, especially psychiatric adverse events. So far, European and United States regulatory agencies have not confirmed a causal relationship between these drugs and suicidality. Continued post-marketing monitoring remains warranted, given their growing use for weight management. METHODS: This study aimed to provide an updated pharmacovigilance analysis of suicide or self-injury-related events reported with liraglutide, semaglutide, and tirzepatide. Individual Case Safety Reports listing liraglutide, semaglutide, or tirzepatide as suspected drugs were retrieved from EudraVigilance. The period covered was 1 January 2021 to 31 December 2025. Reports were included if the indication was consistent with type 2 diabetes mellitus or weight management. Suicide and self-injury events were identified using Preferred Terms from the Standardised MedDRA Query "Suicide/self-injury." Report characteristics were described. Reporting odds ratio (RORs), along with 95% confidence intervals, were calculated to compare the frequency of suicide and self-injury events across the three drugs. RESULTS: We included 42,941 eligible reports. Most reports involved semaglutide, then tirzepatide and liraglutide. Gastrointestinal disorders were the most frequent adverse events, followed by injury, poisoning and procedural complications, and general disorders and administration site conditions. Suicide/self-injury events made up a small portion, with 37 cases for liraglutide, 141 for semaglutide, and 47 for tirzepatide. Compared with tirzepatide, the reporting frequency of these events was higher for liraglutide (ROR 2.54, 95% CI 1.60-4.01) and semaglutide (ROR 2.69, 95% CI 1.91-3.83). CONCLUSIONS: These findings do not establish a causal link between GLP-1 and GLP-1/GIP RAs and suicide or self-injury events but simply provide a comparative analysis of disproportionality. Overall, the results do not contradict regulatory conclusions. They should be interpreted with caution, as spontaneous reporting systems have limitations. Continued pharmacovigilance is warranted, especially as use for weight management increases. |
|---|
| ジャーナル名 | Frontiers in pharmacology |
|---|
| Pubmed追加日 | 2026/9/11 |
|---|
| 投稿者 | Scavone, Cristina; Cerasuolo, Michele; Gaio, Mario; Lettera, Nicoletta; Bernardi, Francesca Futura; Capuano, Annalisa; Rinaldi, Barbara |
|---|
| 組織名 | Department of Experimental Medicine, University of Campania "L. Vanvitelli",;Naples, Italy.;Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples,;Italy.;Department of Life Science, Health, and Health Professions, Link Campus;University, Roma, Italy.;Division of Human Anatomy - Neuronal Networks Morphology and Systems Biology Lab,;Department of Mental, Physical Health and Preventive Medicine, University of;Campania "Luigi Vanvitelli", Naples, Italy.;Coordination of the Regional Health System, General Directorate for Health;Protection, Naples, Italy. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42723821/ |
|---|
