Adverse drug reaction patterns of <scp>GLP</scp> ‐1 receptor agonists approved for obesity treatment: Disproportionality analysis from global pharmacovigilance database
Tae Hyeon Kim, Kyeongmin Lee, Seoyoung Park, Jiyeon Oh, Jaeyu Park, Hyesu Jo, Hayeon Lee, Jaehyeong Cho, Xuerong Wen, Hanseul Cho, Sunyoung Kim, Dong Keon Yon
Abstract
Abstract Aims This study aims to compare adverse drug reaction patterns of liraglutide, semaglutide and tirzepatide—glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) approved for anti‐obesity medications—to evaluate their real‐world safety. Materials and Methods This disproportionality analysis utilized a case–control design with VigiBase. The study focused on reports of adverse events associated with liraglutide, semaglutide and tirzepatide, selected based on warnings in the US Food and Drug Administration approval labels for each drug. Data were restructured using unique identifiers to differentiate individuals affected by adverse drug reactions. Multivariable logistic regression models estimated adjusted reporting odds ratios (aRORs) with 95% confidence intervals (CIs) to assess the association between various adverse events and GLP‐1 RAs, adjusting for age, sex, region, reporter qualification, reporting year and concomitant medication. The information component (IC) was analysed, and signals of adverse drug reactions were considered significant only when both aROR and IC were statistically significant. Results Our analysis of targeted adverse drug reactions included 24 725 individuals using liraglutide, 21 454 using semaglutide and 11 538 using tirzepatide. Tirzepatide had fewer reports of adverse drug reactions compared with the other two drugs, and its pharmacovigilance association strength was the lowest. Semaglutide, however, was significantly associated with several unusual adverse events, including suicidal ideation and behaviour (IC, 1.53 [IC 025 , 1.28]; aROR, 2.52 [95% CI, 2.18–2.93]), hair loss (IC, 0.78 [IC 025 , 0.63]; aROR, 1.42 [95% CI, 1.30–1.55]) and vision loss (IC, 1.27 [IC 025 , 1.13]; aROR, 1.80 [95% CI, 1.66–1.97]). Conclusions Our findings emphasize the need for cautious prescribing and further research to ensure the safe use of these medications.