Evidence mapPaperPMID 41334758Full record

ArticleJournal of the American Heart Association2025

Evolving Trends and Drug Class Dynamics in Drug-Induced Myocarditis: A 2-Decade Comparative Analysis of Pharmacovigilance Data.

Linping Si, Haoyang Xiang, Qingyuan Zhang, Shengyang Xiao, Haitao Yuan

Abstract readComparative Study
In one paragraph

Article in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Linping SiDepartment of Cardiology Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong China.
Haoyang XiangKey Laboratory of Endocrine Glucose & Lipids Metabolism and Brain Aging, Ministry of Education Jinan Shandong China.
Qingyuan ZhangDepartment of Cardiology Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong China.
Shengyang XiaoKey Laboratory of Endocrine Glucose & Lipids Metabolism and Brain Aging, Ministry of Education Jinan Shandong China.ORCID 0009-0007-9952-8620
Haitao YuanDepartment of Cardiology Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong China.ORCID 0000-0002-3445-8250

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrug-induced myocarditis has emerged as an increasingly significant concern with both established and novel medications. This study aimed to identify temporal trends and high-risk populations in drug-induced myocarditis through cross-regulatory pharmacovigilance analysis.

methodsData from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases were analyzed from 2004 to 2023. Drugs associated with myocarditis were identified and classified by therapeutic class, with trends evaluated using linear regression, stratified by age and sex.

resultsDrug-induced myocarditis was reported in 9983 cases in the US Food and Drug Administration Adverse Event Reporting System (increasing from 114 to 1819) and 3718 cases in the Japanese Adverse Drug Event Report database (rising from 18 to 655) from 2004 to 2023. Monoclonal antibodies and antipsychotics were the fastest-growing risk categories, a trend led by monoclonal antibodies in the US Food and Drug Administration Adverse Event Reporting System (+26.82 cases/year) and corroborated in the Japanese Adverse Drug Event Report database (+13.88 cases per year). Clozapine was the most frequently reported single drug in the US Food and Drug Administration Adverse Event Reporting System (12.79% of all cases, +6.96 cases per year). These trends showed consistent patterns across population subgroups; age-stratified analysis revealed that the increase in monoclonal antibodies was concentrated in the older group, whereas the trend for antipsychotics was most prominent in adults. Gender-specific analysis showed that trends for monoclonal antibodies and antipsychotics were more pronounced in men, whereas chemotherapy agents increased more in women.

conclusionsIntegrated analysis of multinational pharmacovigilance data enhances real-time risk detection and underscores the need for precision surveillance strategies targeting high-risk therapies and vulnerable populations.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsMyocarditisPharmacovigilanceAdolescentAdultAgedChildChild, PreschoolDatabases, FactualFemaleHumansJapanMaleMiddle AgedRisk AssessmentFAERSJADERmyocarditispharmacovigilancerisk stratification

Identifiers

PMID41334758
PMCPMC12826943

What Socratic holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.