Abstract
Introduction: Pharmacovigilance studies have definitely established that clozapine can cause myocarditis. Two published reviews suggested that on rare occasions other antipsychotics may induce myocarditis. Areas covered: This review explored myocarditis associated with antipsychotics other than clozapine by conducting a systematic search of the literature and critically analyzing the current data in VigiBase compared to the data on clozapine-associated myocarditis. VigiBase is the World Health Organization’s global pharmacovigilance database that uses a statistical signal for associations with a logarithmic measure of disproportionality called the information component (IC). Expert opinion: For quetiapine, VigiBase provided 106 reports of myocarditis and a significant statistical signal (IC = 1.8; IC025 = 1.5) which was confounded by 48% (51/106) with clozapine co-prescription. Combining the literature and VigiBase cases provided five probable myocarditis cases during quetiapine monotherapy (4 after overdose or rapid titration). For olanzapine, VigiBase provided 107 reports of myocarditis and a significant statistical signal (IC = 2.1; IC025 = 1.8) probably explained by 77% (82/107) using clozapine co-prescription. Combining the literature and VigiBase cases provided one probable myocarditis case during olanzapine monotherapy. Combining the literature and VigiBase provided another three probable cases during therapy with other antipsychotics during overdose or titration with a high dose.
| Original language | English |
|---|---|
| Pages (from-to) | 65-78 |
| Number of pages | 14 |
| Journal | Expert Review of Clinical Pharmacology |
| Volume | 15 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2022 |
Bibliographical note
Publisher Copyright:© 2022 Informa UK Limited, trading as Taylor & Francis Group.
Funding
J de Leon has previously received researcher-initiated grants from Eli Lilly, Roche Molecular Systems, Inc and, in a collaboration with Genomas, Inc., from the NIH Small Business Innovation Research program. He has previously served on the advisory boards of Bristol-Myers Squibb and AstraZeneca. He has previously received support from Roche Molecular Systems for an educational presentation. His lectures have been supported by; Sandoz, Lundbeck, Pfizer, Eli Lilly, Janssen, Bristol-Myers Squibb and Roche Molecular Systems, Inc. The authors have no other 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 apart from those disclosed. This paper was not funded. The authors are indebted to the national centers that make up the World Health Organization (WHO) Program for International Drug Monitoring and contribute reports to VigiBase. The information comes from a variety of sources, and the probability that the suspected adverse effect is drug-related is not the same in all cases. However, the opinions and conclusions of this study are not necessarily those of the various centers nor of the WHO. The authors acknowledge Lorraine Maw, from the University of Kentucky Mental Health Research Center at Eastern State Hospital, who helped in editing the article.
| Funders | Funder number |
|---|---|
| Lorraine Maw | |
| Roche Molecular Systems, Inc. | |
| University of Kentucky Mental Health Research Center at Eastern State Hospital | |
| National Institutes of Health (NIH) | |
| Bristol-Myers Squibb | |
| Eli Lilly and Company | |
| Pfizer | |
| World Health Organization | |
| Janssen Pharmaceuticals | |
| Sandoz | |
| H. Lundbeck A/S | |
| national centers that make up the World Health Organization |
Keywords
- Antipsychotic agents/administration and dosage
- antipsychotic agents/adverse effects
- antipsychotic agents/poisoning
- antipsychotic agents/toxicity
- mortality/drug effects
- myocarditis/chemically induced
- myocarditis/etiology
- olanzapine/adverse effects
- quetiapine/adverse effects
- quetiapine/poisoning
ASJC Scopus subject areas
- General Pharmacology, Toxicology and Pharmaceutics
- Pharmacology (medical)