Mining and comparation on the risk signals related to allopurinol and febuxostat based on the US Food and Drug Administration Public Data Open Project database
10.3760/cma.j.cn114015-20221230-01194
- VernacularTitle:基于美国FDA公共数据开放项目数据库的别嘌醇和非布司他风险信号的挖掘和比较
- Author:
Meijuan ZHANG
1
;
Hang YIN
1
;
Jiangshuo LI
1
;
Mengyu HOU
1
;
Jingxuan WU
1
;
Ruihua DONG
1
Author Information
1. 首都医科大学附属北京友谊医院研究型病房，北京 100050
- Publication Type:Journal Article
- Keywords:
Gout;
Gout Suppressants;
Allopurinol;
Febuxostat;
Adverse event;
OpenFDA;
Safety
- From:
Adverse Drug Reactions Journal
2023;25(8):460-468
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine and compare the adverse event (AE) signals of allopurinol and febuxostat and provide reference for the rational and safe use of the 2 drugs in clinic.Methods:The AE reports on allopurinol and febuxostat from January 1, 2009 to December 31, 2021 were collected by searching the US Food and Drug Administration Public Data Open Project (openFDA) database. AEs were classified using preferred term (PT) and systemic organ class (SOC) of the International Medical Terminology Dictionary 25.0. The AE risk signals of allopurinol and febuxostat were mined using the reporting odds ratio ( ROR) method. The number of AE reports ≥3 and the lower limit of the 95% confidence interval ( CI) of the ROR>1 was defined as a positive signal. The new AE risk signals of allopurinol and febuxostat were screened according to the drug labels. The radar chart was drawn according to the number of allopurinol and febuxostat risk signals. The positive PT signals were descriptively and statistically analyzed. Results:The number of AE reports of allopurinol and febuxostat were 105 532 and 9 949, respectively. The analysis of the top 100 AE reports were as follows. There were 82 positive PT signals of allopurinol, involving 14 SOCs, and 61 AEs were not recorded in the drug labels; there were 86 positive PT signals of febuxostat, involving 18 SOCs, and 25 AEs were not recorded in the drug labels. The top 5 PTs in the signal strength of allopurinol were drug reaction with eosinophilia and systemic symptoms, end-stage renal disease, hypercalcemia, acute kidney injury, and chronic kidney disease; the top 5 PTs in the signal strength of febuxostat were enthesopathy, granuloma skin, blood parathyroid hormone decreased, tenosynovitis and alanine aminotransferase abnormal. The 2 drugs had a total of 49 overlapping signals. More AE signals of allopurinol were detected in SOCs of metabolic and nutritional diseases, blood and lymphatic system diseases etc.; more AE signals of febuxostat were detected in SOCs of skin and subcutaneous tissue diseases, various musculoskeletal, and connective tissue diseases, etc.Conclusions:Allopurinol has a higher risk of causing AEs related to kidney and urinary system, blood and lymphatic system, and metabolic system, while febuxostat has a higher risk of causing AEs related to skin and subcutaneous tissue, musculoskeletal and connective tissue, and hepatobiliary system. It is suggested that patients with gout accompanied by renal insufficiency, urinary system diseases or blood diseases should be careful with allopurinol, and the patients with gout accompanied by liver dysfunction should be careful with febuxostat.
