A pharmacovigilance study of the association between antipsychotic drugs
and Venous thromboembolism based on Food and Drug Administration adverse
event reporting system data
Abstract
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.