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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Predictive Toxicology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1526836

Drug-induced dermatomyositis: a pharmacovigilance study of the FDA adverse event reporting system

Provisionally accepted
Jianing Bi Jianing Bi 1Hanzhang Xie Hanzhang Xie 1Yixuan Yang Yixuan Yang 2Qiaochu Chen Qiaochu Chen 2Bingnan Cui Bingnan Cui 2*ZhanShuo Xiao ZhanShuo Xiao 2*
  • 1 Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
  • 2 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

The final, formatted version of the article will be published soon.

    Background: Dermatomyositis (DM) is an autoimmune disease that may be triggered by certain medications. However, most studies have focused on specific drugs, lacking a comprehensive overview. This study uses the FDA's Adverse Event Reporting System (FAERS) to explore the correlation between DM and medications.The study encompassed FAERS reports from January 2004 to June 2024. We coded and classified adverse events (AEs) using MedDRA and conducted multiple disproportionality analyses (ROR, PRR, BCPNN, MGPS) to examine drug-event associations and analyze the results.Results: Using the 'primary suspects' role code in FAERS, 1767 reports involving 353 drugs suspected of inducing DM were identified. Among 24 signal-positive drugs, cardiovascular drugs (297 reports, mainly statins) were most frequent, followed by immunotherapy agents (188 reports, mainly Immune Checkpoint Inhibitors) and chemotherapy agents (147 reports, mainly Antimetabolites).Conclusions: This study on drug-induced DM presents a new approach to rational and evidence-based drug prescribing. It leverages advanced model algorithms to significantly improve the precision in predicting drug-DM correlations, enhancing patient safety. Additionally, the study provides clinicians with guidance on avoiding medications associated with DM in patients with predisposing factors that may increase their risk of developing the condition.

    Keywords: adverse events, Dermatomyositis, Drug-induced dermatomyositis, FAERS, Pharmacovigilance

    Received: 12 Nov 2024; Accepted: 02 Jan 2025.

    Copyright: © 2025 Bi, Xie, Yang, Chen, Cui and Xiao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Bingnan Cui, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
    ZhanShuo Xiao, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.