Signal Mining Study of Adverse Reaction Associated with Allopurinol and Febuxostat Based on FDA Adverse Events Reporting System(FAERS)Database
10.3870/j.issn.1004-0781.2024.04.026
- VernacularTitle:基于FDA不良事件报告系统数据库的别嘌醇和非布司他不良事件信号挖掘研究
- Author:
Lu WEN
1
,
2
,
3
;
Li CHEN
;
Xucheng HE
;
Jia CHENG
;
Yuan XU
Author Information
1. 四川大学华西第二医院药学部/循证药学中心,成都 610041
2. 出生缺陷与相关妇儿疾病教育部重点实验室,成都 610041
3. 成都市温江区人民医院/四川省医学科学院· 四川省人民医院温江医院药学部,成都 611130
- Keywords:
Allopurinol;
Febuxostat;
FDA adverse event reporting system(FAERS)database;
Adverse reaction signal mining;
Reporting odds ratio method;
Proportional reporting ratio method
- From:
Herald of Medicine
2024;43(4):639-647
- CountryChina
- Language:Chinese
-
Abstract:
Objective To conduct signal mining of adverse events(AEs)of allopurinol and febuxostat based on FAE-RS database,and to explore their potential drug risks and promote rational and safe clinical drug use.Methods The adverse event report data of febuxostat and allopurinol in 22 quarters from the first quarter of 2017 to the second quarter of 2022 were ex-tracted from FAERS database,and the signal mining of febuxostat and allopurinol adverse events(AE)was carried out using ROR method and PRR method.Results There were 5 060 AE reports for allopurinol,concentrated in patients aged≥60 years,in-volving 25 items of system organ classification(SOC),mainly in skin and subcutaneous tissue diseases(40.01%).It was found that 12 SOC categories were not mentioned in the instructions.For febuxostat,there were 905 AE reports,involving 17 SOC items,mainly in cardiac organ diseases(40.17%),and 2 items were not involved in the instructions.Allopurinol and febuxostat were as-sociated with infection and infectious diseases(5.51%,0.49%)and hepatobiliary diseases(5.35%,0.87%),However,these as-sociations were included in the instructions of allopurinol.Allopurinol was associated with the reproductive system and breast dis-eases(0.55%),pregnancy,puerperium and perinatal conditions(0.03%),but febuxostat was not found to be involved in the a-bove SOC.Conclusion The inclusion of adverse reactions in the instructions for allopurinol is relatively inadequate compared to buprostat,and the newly discovered involvement of systemic organs and AE can provide a reference for improving allopurinol in-structions.This study found that allopurinol and febuxostat allopurinol and febuxostat involved system differences,which can pro-vide reference for clinical individualized treatment.
