Article ; Online: Psychiatric adverse events associated with semaglutide, liraglutide and tirzepatide: a pharmacovigilance analysis of individual case safety reports submitted to the EudraVigilance database.
International journal of clinical pharmacy
2024 Volume 46, Issue 2, Page(s) 488–495
Abstract: Background: Semaglutide, liraglutide and tirzepatide are glucagon-like peptide-1 (GLP-1) receptor agonists that are effective for weight reduction. Recent reports of patients experiencing suicidal thoughts and other psychiatric adverse events while ... ...
Abstract | Background: Semaglutide, liraglutide and tirzepatide are glucagon-like peptide-1 (GLP-1) receptor agonists that are effective for weight reduction. Recent reports of patients experiencing suicidal thoughts and other psychiatric adverse events while using GLP-1 agonists have raised concerns about the potential risk of self-harm and led the European Medicines Agency to investigate these medications. Aim: To identify and analyse the psychiatric adverse events associated with semaglutide, liraglutide and tirzepatide. Method: All individual case safety reports for semaglutide, liraglutide, and tirzepatide reported to the EudraVigilance database from 01/01/2021 to 30/05/2023 were analysed. Descriptive statistics were used to explore study population characteristics. Results: During the study period, 31,444 adverse event reports were identified: semaglutide (n = 13,956; 44.4%), liraglutide (n = 16,748; 53.2%), and tirzepatide (n = 740; 2.3%). There were 372 reports with psychiatric adverse event reports (n = 372; 1.18%) with a total of 481 adverse events. Women accounted for 65% (n = 242) of these reports. Depression was the most commonly reported adverse event (n = 187; 50.3%), followed by anxiety (n = 144; 38.7%) and suicidal ideation (n = 73; 19.6%). Nine deaths (8 with liraglutide and 1 with semaglutide) and 11 life-threatening outcomes (4 associated with liraglutide and 7 with semaglutide) were reported. The fatal outcomes occurred primarily among men (8 out of 9) resulting from completed suicidal attempts and depression. Conclusion: Psychiatric adverse events comprised only 1.2% of the total reports for semaglutide, liraglutide, and tirzepatide. However, the severity and fatal outcomes of some of these reports warrant further investigation. |
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MeSH term(s) | Male ; Humans ; Female ; Liraglutide/adverse effects ; Hypoglycemic Agents/adverse effects ; Diabetes Mellitus, Type 2/drug therapy ; Pharmacovigilance ; Glucagon-Like Peptide-1 Receptor/agonists ; Glucagon-Like Peptide-1 Receptor/therapeutic use ; Glucagon-Like Peptide-2 Receptor ; Glucagon-Like Peptides ; Gastric Inhibitory Polypeptide |
Chemical Substances | Liraglutide (839I73S42A) ; Hypoglycemic Agents ; semaglutide (53AXN4NNHX) ; tirzepatide (OYN3CCI6QE) ; Glucagon-Like Peptide-1 Receptor ; Glucagon-Like Peptide-2 Receptor ; Glucagon-Like Peptides (62340-29-8) ; Gastric Inhibitory Polypeptide (59392-49-3) |
Language | English |
Publishing date | 2024-01-24 |
Publishing country | Netherlands |
Document type | Journal Article |
ZDB-ID | 2601204-2 |
ISSN | 2210-7711 ; 2210-7703 ; 0928-1231 |
ISSN (online) | 2210-7711 |
ISSN | 2210-7703 ; 0928-1231 |
DOI | 10.1007/s11096-023-01694-7 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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