Evaluating safety risks of ischaemic colitis with taxanes: a disproportionality analysis based on FDA adverse event Reporting system.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-07-02 DOI:10.1080/14740338.2025.2529429

Yufang Liao, Yanbin Zeng, Xiaorong Su, Wanlong Lin, Xiuxian Lin, Lizhu Weng, Jianhui Yang, Wei Zhuang, Junyan Wu

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引用次数: 0

Abstract

Background: Ischaemic colitis (IC) is a rare yet serious gastrointestinal condition, increasingly reported in patients receiving taxanes-based chemotherapy. So far, the correlation between the two remains unclear. The aim of this study is to assess the safety concerns associated with taxanes use in relation to IC.

Research design and methods: Disproportionality analyses (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], Multi-item gamma Poisson Shrinker [MGPS]) were conducted using the FDA Adverse Event Reporting System (FAERS, 2005 Q1-2023 Q2).

Results: Significant IC signals were detected across taxanes: paclitaxel (ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05), nab-paclitaxel (ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,), and docetaxel (ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59). Reports were predominantly from Japan and the U.S.A. with IC developing within 16 days in half of the patients.

Conclusion: Taxanes may substantially increase IC risk, necessitating vigilant gastrointestinal monitoring and characterization of high-risk populations. Further clinical validation is required to confirm these findings.

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评价紫杉烷类药物治疗缺血性结肠炎的安全风险：基于FDA不良事件报告系统的歧化分析。

背景：缺血性结肠炎（IC）是一种罕见但严重的胃肠道疾病，在接受紫杉烷类化疗的患者中越来越多地报道。到目前为止，两者之间的关系尚不清楚。研究设计和方法：使用FDA不良事件报告系统（FAERS， 2005年第一季度-2023年第二季度）进行歧化分析（报告优势比[ROR]、比例报告比[PRR]、贝叶斯置信传播神经网络[BCPNN]、多项目γ泊松收缩器[MGPS]）。结果：紫杉醇（ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05）、nab-紫杉醇（ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,）和多西紫杉醇（ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59）在紫杉醇类中均检测到显著的IC信号。报告主要来自日本和美国，半数患者在16天内发生IC。结论：紫杉烷类药物可能显著增加IC的风险，有必要警惕胃肠道监测和高危人群的特征。需要进一步的临床验证来证实这些发现。

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.