Disproportionality analysis of drug-induced myocarditis: Insights from the Food and Drug Administration Adverse Event Reporting System database.
This FAERS disproportionality study identified 9,014 myocarditis reports from 2004–2023, with chemotherapy commonly represented, substantial hospitalization and death reporting, clozapine having the most reports, and phendimetrazine showing the strongest reporting association.
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This FAERS disproportionality study identified 9,014 myocarditis reports from 2004–2023, with chemotherapy commonly represented, substantial hospitalization and death reporting, clozapine having the most reports, and phendimetrazine showing the strongest reporting association.
Research significance
The evidence supports pharmacovigilance signals—not causal drug risks—suggesting that targeted cardiac monitoring of patients receiving drugs with disproportionate myocarditis reporting could potentially enable earlier toxicity detection; pediatric benefit remains inferential because age-specific pediatric results are not provided.
Source abstract
ObjectiveDrug-induced myocarditis is a rare but serious adverse events that may have a significant impact on patient prognosis. To identify signals of disproportionate reporting associated with drug-induced myocarditis, we conducted descriptive and disproportionality analyses of the United States Food and Drug Administration Adverse Event Reporting System database.MethodsThis study analyzed Food and Drug Administration Adverse Event Reporting System data from 2004 to 2023, focusing on myocarditis-related reports. We examined patient demographics, clinical prognosis, reporting country, and reporter type. A disproportionality analysis was conducted to assess the association between drugs and myocarditis, focusing on the 50 most frequently reported drugs.ResultsAmong 20,753,288 adverse events in the Food and Drug Administration Adverse Event Reporting System database, 9014 (0.04%) were cases of drug-induced myocarditis, with reports increasing from 101 in 2004 to 1543 in 2023. Most cases occurred in male patients (52.63%) and patients aged 41-64 years, with chemotherapeutic agents being the drug group most commonly associated with myocarditis, making cancer the leading indication (32.5%). The United States reported the highest number of cases (20.87%). Physicians and pharmacists submitted the majority of reports (42.62% and 25.96%, respectively). Clinical outcomes included hospitalization (35.24%) and death (12.82%). Clozapine was the most frequently reported drug, whereas phendimetrazine showed the strongest association with myocarditis.ConclusionsThis study identifies key risk factors for drug-induced myocarditis using Food and Drug Administration Adverse Event Reporting System data. Although cases are rare, their severity highlights the need for improved monitoring. Enhanced pharmacovigilance, especially for high-risk drugs, is crucial to reduce the incidence of myocarditis and improve patient outcomes.