Capecitabine-associated gastrointestinal ulceration, haemorrhage, and obstruction: a pharmacovigilance analysis based on the FAERS

作者全名：Wang, Yuwei; Meng, Long; Liu, Xiao

作者地址：[Wang, Yuwei] Chongqing Univ, Dept Radiat Oncol, Canc Hosp, Chongqing, Peoples R China; [Meng, Long] Chongqing Med Univ, Dept Pharm, Affiliated Hosp 1, Chongqing, Peoples R China; [Liu, Xiao] Fifth Peoples Hosp Chongqing, Dept Gastrointestinal Surg, Chongqing, Peoples R China

通信作者：Liu, X (通讯作者)，Fifth Peoples Hosp Chongqing, Dept Gastrointestinal Surg, Chongqing, Peoples R China.

来源：FRONTIERS IN PHARMACOLOGY

ESI学科分类：PHARMACOLOGY & TOXICOLOGY

WOS号：WOS:001257057300001

JCR分区：Q1

影响因子：4.4

年份：2024

卷号：15

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：adverse drug reactions; capecitabine; FAERS; gastrointestinal ulceration; gastrointestinal haemorrhage; gastrointestinal obstructions

摘要：Background Capecitabine has been reported to be associated with severe gastrointestinal (GI) adverse drug reactions (gastrointestinal ulceration, haemorrhage, and obstruction). However, statistical correlations have not been demonstrated, and specific GI adverse drug reactions, such as GI obstruction, are not listed on its label.Aim We aimed to determine the associations between capecitabine and GI ulceration, haemorrhage, or obstruction among patients with breast cancer by examining data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS).Methods We performed disproportionality analysis of GI ulceration, haemorrhage, and obstruction by evaluating the reporting odds ratio (ROR) and the information component (IC) with their 95% confidence intervals (CIs).Results We identified 279 patients with capecitabine-associated GI ulceration, haemorrhage, or obstruction reported between 1 January 2004 and 31 December 2020. One-fourth of the cases of GI ulceration, haemorrhage, or obstruction resulted in death. Capecitabine as a drug class had disproportionately high reporting rates for GI ulceration [ROR 1.94 (1.71-2.21); IC 0.80 (0.60-0.99)], haemorrhage [ROR 2.27 (1.86-2.76); IC 0.99 (0.69-1.28)], and obstruction [ROR 2.19 (1.63-2.95); IC 0.96 (0.51-1.40)].Conclusion Pharmacovigilance research on the FAERS has revealed a slight increase in reports of GI ulceration, haemorrhage, and obstruction in capecitabine users, which may cause serious or deadly consequences. In addition to the adverse reactions described in the package insert, close attention should be paid to GI obstruction to avoid discontinuation or life-threatening outcomes.

基金机构：Chongqing Health Commission [2022QNXM011]; Science and Technology Bureau [2022QNXM011]

基金资助正文：The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This study is supported by grants from the Joint Project of Chongqing Health Commission and Science and Technology Bureau (Grant No. 2022QNXM011).