Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system

XIONG Rui; LEI Jing; ZHANG Shipeng; ZHANG Hong; TONG Yongtao; LAI Xiaodan

doi:10.6039/j.issn.1001-0408.2024.05.15

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Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system

更新时间：2024-03-08

- Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system
- ZHONGGUO YAOFANG Vol. 35, Issue 5, Pages: 595-600(2024)
- 作者机构：
  
  1.中国人民解放军陆军第九五八医院药剂科，重庆　400020
  2.陆军特色医学中心药剂科，重庆　400042
  3.中国人民解放军陆军第九五六医院药剂科，西藏林芝　860100
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.05.15
  CLC： R969.3;R979.1
- Published：15 March 2024，
  
  Received：17 August 2023，
  
  Revised：22 February 2024，
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熊瑞,雷静,张世鹏等.基于美国FAERS数据库的阿可替尼ADE信号挖掘与分析 ^Δ[J].中国药房,2024,35(05):595-600.

XIONG Rui,LEI Jing,ZHANG Shipeng,et al.Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system[J].ZHONGGUO YAOFANG,2024,35(05):595-600.
熊瑞,雷静,张世鹏等.基于美国FAERS数据库的阿可替尼ADE信号挖掘与分析 ^Δ[J].中国药房,2024,35(05):595-600. DOI： 10.6039/j.issn.1001-0408.2024.05.15.

XIONG Rui,LEI Jing,ZHANG Shipeng,et al.Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system[J].ZHONGGUO YAOFANG,2024,35(05):595-600. DOI： 10.6039/j.issn.1001-0408.2024.05.15.

摘要

目的

挖掘和分析阿可替尼的药物不良事件（ADE）信号，为其临床安全应用提供参考。

方法

通过OpenVigil 2.1平台提取美国FDA不良事件报告系统数据库中2017年11月1日至2023年3月31日与阿可替尼相关的ADE报告，采用报告比值比法与英国药品和健康产品管理局综合标准法对ADE信号进行检测。

结果

提取到以阿可替尼为首要怀疑药物的报告7 869份，从中检测到142个ADE阳性信号，涉及20个系统器官分类，基本与其药品说明书记载的ADE一致，主要涉及全身性疾病及给药部位各种反应、各类检查、血液及淋巴系统疾病、各类神经系统疾病和心脏器官疾病等。此外，还发现了一些未在其药品说明书中提及的新的潜在ADE信号，包括心源性猝死、肺毒性、肿瘤溶解综合征、胸腔积液、消化不良、胃食管反流病、骨痛、血压降低、血钠异常等。

结论

在应用阿可替尼时，除了需要关注其说明书已记载的ADE外，还应评估其包括心源性猝死、肺毒性等可能导致死亡的严重ADE风险，尽可能避免或减少ADE的发生。

Abstract

OBJECTIVE

To provide reference for the clinically safe application of acalabrutinib by mining and analyzing the risk signals of adverse drug events （ADE）.

METHODS

The acalabrutinib-induced ADE reports were extracted from the U.S. FDA adverse event reporting system using the OpenVigil 2.1 platform from November 1， 2017 to March 31， 2023. The reporting odds ratio （ROR） method and composite criteria method from the Medicines and Healthcare Products Regulatory Agency （MHRA） were used for detection of ADE signals.

RESULTS

There were 7 869 ADE reports of acalabrutinib as the primary suspect drug and 142 ADE positive signals were detected from them， involving 20 system organ classes， which was generally consistent with the ADE recorded in the drug instruction of acalabrutinib， mainly involving general disorders and administration site conditions， various inspection， blood and lymphatic system disorders， various neurological disorders and cardiac disorders. In addition， this study identified several new potential ADE signals that were not mentioned in the drug instruction， including sudden cardiac death， pulmonary toxicity， tumor lysis syndrome， pleural effusion， dyspepsia， gastroesophageal reflux disease， bone pain， decreased blood pressure， and abnormal blood sodium， etc.

CONCLUSIONS

When using acalabrutinib， in addition to paying attention to the ADE recorded in its instructions， the risk of serious ADE that may lead to death， such as sudden cardiac death and pulmonary toxicity， should also be evaluated to avoid or reduce the occurrence of ADE as much as possible.

关键词

阿可替尼药物不良事件数据挖掘FDA不良事件报告系统套细胞淋巴瘤

Keywords

adverse drug eventdata miningFDA adverse event reporting systemmantle cell lymphoma

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