Drug-induced myocarditis: a real-world pharmacovigilance study using the FDA adverse event reporting system database

Abstract

ABSTRACT Background Myocarditis is a rare but potentially life-threatening inflammation of the heart muscle that can be caused by various drugs. This study aimed to comprehensively evaluate the risk of drug-induced myocarditis using data from the FDA Adverse Event Reporting System (FAERS) database. Methods We queried the FAERS database for reports of myocarditis from Q1 2004 to Q4 2023. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were calculated to detect disproportionality signals for drugs associated with myocarditis. Results A total of 8,212 myocarditis-related reports were identified in the FAERS database. The most frequently reported drugs were clozapine (N = 1269), followed by nivolumab (N = 621), pembrolizumab (N = 358), mesalazine (252), and olanzapine (N = 191). Disproportionality analysis revealed strong signals for the top 50 drugs, including mesalazine (ROR 48.01, 95% CI 42.29-54.49), cemiplimab (ROR 38.84, 95% CI 26.71-56.47), clozapine (ROR 35.21, 95% CI 33.13-37.39), nivolumab (ROR 23.21, 95% CI 21.38-25.2), atezolizumab (ROR 20.75, 95% CI 17.91-24.05) and pembrolizumab (ROR 19.90, 95% CI 17.89-22.13). Conclusions Our findings suggest a potential risk of drug-induced myocarditis associated with various medications. Close monitoring for signs and symptoms of myocarditis is crucial, especially in patients with risk factors or those receiving these drugs. Further investigations are warranted to establish causality and identify risk factors.