Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

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The use of antipsychotic drugs is a known risk for thromboembolism, but this risk has not been sufficiently analyzed in the Japanese population. We aimed to analyze the association between antipsychotic drug use and thromboembolism in a Japanese population and to clarify the factors that lead to serious consequences.

We extracted cases of thromboembolism during antipsychotic drug use from the Japanese Adverse Drug Event Report database from April 2004 to July 2020. Then we classified the cases according to a favorable or unfavorable outcome. “Favorable” included recovery and recovering, whereas “unfavorable” included recovered with sequelae, unrecovered, and death. Multivariate logistics regression analysis was performed to determine the factors behind the adverse outcomes.

From 32,421 patients who were on antipsychotic drugs, 1,111 thromboembolism cases were identified, and 903 were ultimately included in the analysis. In all, 489 thromboembolism cases were classified as favorable, and 414 were classified as unfavorable. Overall, 169 cases had arterial thromboembolism (ATE), 414 had venous thromboembolism (VTE), and 320 had vessel type unspecified and mixed arterial and venous thromboembolism. The combination of three or more antipsychotics was identified as prognostic factors for an unfavorable outcome of thromboembolism under antipsychotic drugs. On the other hand, patients who were also on hormone therapy tended to have favorable outcomes.

ATE and VTE have different etiologies and prognoses, but the risk of developing them should be considered when administering antipsychotic drugs. Particular attention should be paid to the development of serious thromboembolism with the combined use of three or more antipsychotics.

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