Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system
- VernacularTitle:基于美国FAERS数据库的阿可替尼ADE信号挖掘与分析
- Author:
Rui XIONG
1
;
Jing LEI
2
;
Shipeng ZHANG
1
;
Hong ZHANG
3
;
Yongtao TONG
3
;
Xiaodan LAI
1
Author Information
1. Dept. of Pharmacy，the 958th Hospital of Chinese PLA，Chongqing 400020，China
2. Dept. of Pharmacy，Army Medical Center of PLA，Chongqing 400042，China
3. Dept. of Pharmacy，the 956th Hospital of Chinese PLA，Xizang Nyingchi 860100，China
- Publication Type:Journal Article
- Keywords:
acalabrutinib;
adverse drug event;
data mining;
FDA adverse event reporting system;
mantle cell lymphoma
- From:
China Pharmacy
2024;35(5):595-600
- CountryChina
- Language:Chinese
-
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.
