Analysis of Psychiatric Adverse Events for Semaglutide, Liraglutide, and Tirzepatide Reported to the EudraVigilance Database

Abstract

Abstract Background Weight reduction is essential for improving health in people with obesity and type 2 diabetes mellitus. Semaglutide, liraglutide, and tirzepatide are glucagon-like peptide-1 receptor agonists that are effective for weight management in conjunction with behavioral changes. Aim To identify and analyse the occurrence and the outcome of psychiatric adverse events associated with semaglutide, liraglutide, and tirzepatide. Methods All individual case safety reports (ICSR) for semaglutide, liraglutide, and tirzepatide reported to the EudraVigilance database from 01/01/2021 to 5/30/2023 were analysed. Descriptive statistics were used to describe the study population characteristics. Differences in proportions between the groups were compared using the chi-square test. Results During the study period, 31,444 adverse events 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 events 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 suicide 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 study.