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

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.

KEYWORDS:

• Pharmacovigilance
• pulmonary thromboembolism
• deep venous thrombosis
• venous thromboembolism
• antipsychotics

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Bin Wu and Yu Yan designed the research. Yu Yan., Ling Wang, Yan Ling. Yuan performed data acquire and analysis of the paper. Yu Yan and JiaYue Xu contributed to data interpretation. Bin Wu and Yu Yan had over all oversight of the paper construction.

Acknowledgments

The authors are very grateful to all staffs of the Department of Pharmacy, West China Hospital, Sichuan University and West China College of Pharmacy, Sichuan University. This research was supported by National Key Clinical Specialties Construction Program.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2251881

Additional information

Funding

This paper was not funded.