Clozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries

Translated title of the contribution: Clozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries

Carlos De las Cuevas, Emilio J. Sanz, Can Jun Ruan, Jose de Leon

Research output: Contribution to journalArticlepeer-review

37 Scopus citations

Abstract

Introduction: The incidence of clozapine-associated myocarditis varies by country. These variations were explored in VigiBase, the World Health Organization's global database which has >25 million spontaneously reported adverse drug reaction (ADR) reports from 145 national drug agencies. Methods: On January 15, 2021, a search of VigiBase since inception focused on myocarditis in clozapine patients. The 3572 individual reports were studied using the standard VigiBase logarithmic measure of disproportionality called information component (IC). The IC measures the disproportionality between the expected and the reported rates. After duplicates were eliminated there were 3274 different patients with myocarditis studied in logistic regression models. Results: The first case was published in 1980 but since 1993 the VigiBase clozapine-myocarditis IC has been significant; moreover, currently it is very strong (IC = 6.0, IC005–IC995 = 5.9–6.1) and statistically significantly different from other antipsychotics. Of the 3274 different patients with myocarditis, 43.4% were non-serious cases, 51.8% were serious but non-fatal, and 4.8% were fatal. More than half (1621/3274) of the reports came from Australia, of which 69.2% were non-serious, 27.7% serious but non-fatal, and 3.1% fatal. Asian countries contributed only 41 cases. Conclusions: In pharmacovigilance studies, confounding factors may explain statistical associations, but the strength and robustness of these results are compatible with the hypothesis that myocarditis is definitively associated with early clozapine treatment (84% [1309/1560] and 5% [82/1560] in the first and second months). Myocarditis reports from Australia are over-represented to a major degree. Asian countries may be underreporting myocarditis to their drug agencies.

Translated title of the contributionClozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries
Original languageEnglish
Pages (from-to)238-250
Number of pages13
JournalRevista de Psiquiatria y Salud Mental
Volume15
Issue number4
DOIs
StatePublished - Oct 1 2022

Bibliographical note

Publisher Copyright:
© 2021 SEP y SEPB

Keywords

  • Clozapine/adverse effects
  • Clozapine/metabolism
  • Clozapine/toxicity
  • Mortality/drug effects
  • Myocarditis/chemically induced

ASJC Scopus subject areas

  • Psychiatry and Mental health

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