Signals mining and analysis of adverse drug events of pazopanib based on FAERS database
- VernacularTitle:基于美国FAERS数据库的培唑帕尼不良事件信号挖掘与分析
- Author:
Mingming BO
1
,
2
;
Yafei SHI
1
,
2
;
Jixiong SUN
3
;
Tianyu WANG
2
;
Guohui LI
1
;
Yuanyuan DAI
1
Author Information
1. Dept. of Pharmacy，National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital，Chinese Academy of Medical Sciences and Peking Union Medical College，Beijing 100021，China
2. Dept. of Pharmacy，Langfang Branch，National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital，Chinese Academy of Medical Sciences，Hebei Langfang 065001，China
3. Information Management Center，Langfang Branch，National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital，Chinese Academy of Medical Sciences，Hebei Langfang 065001，China
- Publication Type:Journal Article
- Keywords:
pazopanib;
adverse drug event;
signal
- From:
China Pharmacy
2023;34(15):1879-1883
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine and analyze adverse drug event （ADE） signals after the marketing of pazopanib and provide references for clinically safe medication. METHODS OpenVigil 2.1 data platform was used to mine ADE signals from the US FDA adverse event reporting system （FAERS） database. ADE reports of pazopanib from October 2009 to June 2022 were collected， and ADE signals were analyzed using proportional reporting ratio （PRR） method and reporting odds ratio （ROR） method in the proportional imbalance method. RESULTS A total of 16 655 ADE reports were identified with pazopanib as the primary suspect drug. Through ROR and PRR analysis， 220 ADE signals involving 19 system organ classes were identified. The top 10 ADE signals by frequency were recorded in the drug instruction. Additionally， 88 new ADE signals were discovered， mainly related to the gastrointestinal system， various investigations， and the renal and urinary system. Decreased basophil count， nail bed hemorrhage， tumor rupture， and vaginal fistula were both new ADE signals and the top 10 ADE signals by strength. CONCLUSIONS The occurrence of common ADEs （diarrhea， hair color changes， hypertension， etc.） during the use of pazopanib after marketing is generally consistent with its drug instruction； the number of reported cases for new suspected risk signals （decreased basophil count， nail bed hemorrhage， tumor rupture， and vaginal fistula， etc.） is limited， and continuous monitoring is required.
