A pharmacovigilance study of the association between antipsychotic drugs and venous thromboembolism based on Food and Drug Administration Adverse Event Reporting System data

Abstract

ABSTRACT Background This study aimed to measure and present a comprehensive overview of the association of antipsychotic drugs and venous thromboembolism (VTE) in the Food and Drug Administration Adverse Event Reporting System (FAERS). Method: All VTE cases treated with antipsychotic drugs as primary suspected medicines were extracted from the FAERS database from 2004 to 2021. Disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and the information component (IC). Results In the FAERS system, 4,455 VTE cases associated with antipsychotics were identified. The VTE signal was detected with olanzapine, haloperidol, paliperidone, and quetiapine. The RORs and 95% confidence intervals (95% CI) of olanzapine, haloperidol, paliperidone, and quetiapine were (ROR = 2.53 95% Cl 2.38–2.69 IC = 1.31 95% Cl 1.11–1.52), (ROR = 2.17 95% Cl 1.91–2.46 IC = 1.1 95% Cl 0.66–1.52), (ROR = 1.6 95% Cl 1.4–1.83 IC = 0.67 95% Cl 0.22–1.11), and (ROR = 1.37 95% Cl 1.28–1.47 IC = 0.45 95% Cl 0.23–0.67). Pulmonary embolism occurred in more than 50% of VTE events (2760 cases, 52.84%). Conclusion The data mining of FAERS suggested an association between VTE and antipsychotic drugs, which reminds medical workers to pay attention to the serious adverse drug effects of antipsychotic drugs leading to venous thromboembolism.