Signal mining of hypoxia-inducible factor prolyl hydrocylase inhibitor-related adverse events based on US FDA Adverse Event Reporting System database
10.3760/cma.j.cn114015-20240126-00064
- VernacularTitle:基于美国FDA不良事件报告系统数据库的低氧诱导因子脯氨酰羟化酶抑制剂不良事件风险信号挖掘
- Author:
Dandan WU
1
;
Ying ZENG
1
;
Weihua LAI
1
Author Information
1. 南方医科大学附属广东省人民医院药学部（广东省医学科学院），广州 510080
- Publication Type:Journal Article
- Keywords:
Hypoxia-inducible factor prolyl hydroxylase inhibitors;
Roxadustat;
Daprodustat;
Vadadustat;
Adverse events signal mining
- From:
Adverse Drug Reactions Journal
2024;26(8):474-479
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the risk signals of hypoxia-inducible factor prolyl hydrocylase inhibitor (HIF-PHI)-related adverse events (AEs) and provide reference for the safe use of the drugs in clinic practice.Methods:AE reports of HIF-PHI drugs were collected from the US FDA Adverse Event Reporting System (FAERS) database during January 1, 2004 to September 30, 2023. AEs were classified and standardized according to the system organ class (SOC) and the preferred term (PT) in Medical Dictionary for Regulatory Activities 25.0. The AE risk signals of above mentioned 3 drugs were mined using reporting odds ratio (ROR) method. An AE with reports ≥3 and the lower limit of the 95% confidence interval ( CI) of ROR >1 was defined as a risk signal. Descriptive analysis on the signals was performed. Results:Only AE report data for roxadustat, daprodustat, and vacladustat were collected. A total of 78 AE reports related to roxadustat were collected, involving 12 PTs and 8 SOCs. The top 5 PTs in signal intensity were shunt occlusion, central hypothyroidism, gastrointestinal perforation, colon cancer, and hepatic function abnormal. Except for central hypothyroidism, the other 4 were not recorded in the labels. A total of 459 AE reports related to daprodustat were collected, involving 29 PTs and 13 SOCs. The top 5 PTs in signal intensity were gastrointestinal erosion, retinal haemorrhage, haemorrhoidal haemorrhage, abnormal feces and colon cancer. Retinal haemorrhage, abnormal feces and colon cancer were new adverse events not recorded in the labels. A total of 26 AE reports related to vadadustat were collected, involving 6 PTs and 4 SOCs. The top 5 PTs in signal intensity were drug eruption, face oedema, colon cancer, gastrointestinal haemorrhage, and dehydration, all of which were new adverse event not recorded in the labels.Conclusions:The risk signals of roxadustat, daprodustat and vadadustat are mostly adverse events not recorded in the labels, such as shunt obstruction, gastrointestinal perforation, colon cancer, etc. When using the 3 drugs, clinicians should not only pay attention to the adverse reactions recorded in the labels, but also be alert to the adverse events not recorded in the labels.
