Drug-induced noninfectious myocarditis: a disproportionality analysis of the FAERS database.

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2024-11-03 DOI:10.1080/14740338.2024.2423679

Liyuan Yan, Guanqun Zheng

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引用次数: 0

Abstract

Background: This investigation aims to identify and evaluate the most common and critical drugs associated with the risk of noninfectious myocarditis utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: Data pertaining to noninfectious myocarditis from 2004 Q1 to 2024 Q2 were extracted. Following data standardization, multiple signal quantification techniques, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio, were employed for analysis.

Results: The study identified a total of 10,763 adverse event reports associated with noninfectious myocarditis. Disproportionality analysis revealed that the top 5 drugs by ROR were phendimetrazine tartrate (ROR 104.64), trimethoprim + sulfamethoxazole (ROR 67.65), aldesleukin (ROR 52.67), mesalazine (ROR 49.73), and balsalazide disodium (ROR 45.26). Notably, among the 30 drugs with the strongest ROR signals, 8 drugs lacked myocarditis risk information in their package inserts.

Conclusion: Through comprehensive analysis of the FAERS database, our study identified drugs with a strong signal for myocarditis that are not currently indicated on their labels. The findings suggest that the potential risk of myocarditis associated with these medications is significant and warrants close monitoring in clinical practice.

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药物诱发的非感染性心肌炎：FAERS 数据库的比例失调分析。

背景：本调查旨在利用美国食品和药物管理局不良事件报告系统（FAERS）数据库，确定并评估与非感染性心肌炎风险相关的最常见和最关键药物：这项调查旨在利用美国食品和药物管理局不良事件报告系统（FAERS）数据库，确定和评估与非感染性心肌炎风险相关的最常见和最重要的药物：提取2004年第一季度至2024年第二季度与非感染性心肌炎相关的数据。数据标准化后，采用多种信号量化技术进行分析，包括报告比值比（ROR）和比例报告比：研究共发现了 10,763 份与非感染性心肌炎相关的不良事件报告。比例失调分析显示，按ROR计算，排名前5位的药物分别是酒石酸芬地美嗪（ROR 104.64）、三甲双胍+磺胺甲噁唑（ROR 67.65）、醛固酮（ROR 52.67）、美沙拉秦（ROR 49.73）和巴柳氮二钠（ROR 45.26）。值得注意的是，在 ROR 信号最强的 30 种药物中，有 8 种药物的包装说明书中缺乏心肌炎风险信息：通过对 FAERS 数据库的全面分析，我们的研究发现了目前标签上未标明的心肌炎强信号药物。研究结果表明，这些药物引发心肌炎的潜在风险很大，需要在临床实践中密切监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.