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A pharmacovigilance study of the association between antipsychotic drugs and Venous thromboembolism based on Food and Drug Administration adverse event reporting system data
  • +3
  • Yu Yan,
  • Ling Wang,
  • YanLing Yuan,
  • JiaYue Xu,
  • YuXian Chen,
  • bin wu
YanLing Yuan
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YuXian Chen
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bin wu
Sichuan University West China Hospital

Corresponding Author:[email protected]

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Aims Venous thromboembolism (VTE) is a rare but serious adverse drug reaction could be caused by antipsychotic drugs. However, the specific correlation of VTE caused by antipsychotic drugs is still controversial. This study explored the potential association between antipsychotics and VTE. Method All VTE cases of antipsychotic drugs as primary suspected medicines were extracted from the US Food and Drug Administration adverse event reporting system (FAERS) from 2004 to 2021.Disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and the information component (IC). Results 4, 455 VTE cases with antipsychotics as primary suspected drugs were identified. The VTE signal was detected in haloperidol, olanzapine, quetiapine and paliperidone. The RORs and the 95% confidence intervals (95% CI) of t haloperidol, olanzapine, quetiapine and paliperidone were (ROR=2.17, 95% CI(2.17-1.91), IC=1.1, 95%CI(1.52-0.66)), (ROR 2.53 95% CI 2.69–2.38 IC 1.31 95%CI 1.52-1.1), (ROR 1.37, 95% CI 1.47–1.28 IC 0.45 95%CI 0.67-0.23) and (ROR 1.6 95% CI 1.83–1.4 IC 0.67 95%CI 1.11-0.22), respectively. Pulmonary embolism occurred in more than 50% of VTE events (2760 cases, 52.84%). The outcome indicated that venous thrombosis caused by antipsychotics is usually a serious consequence. Conclusion The current data mining of FAERS suggested an association between VTE and antipsychotic drugs including olanzapine, haloperidol, paliperidone and quetiapine, which reminds health professionals to pay attention to the serious adverse drug effects of antipsychotic drugs leading to venous thromboembolism.