Study on the risk signal mining related to edoxaban based on the US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20220515-00427
- VernacularTitle:基于美国FDA不良事件报告系统数据库的艾多沙班风险信号挖掘
- Author:
Yu WANG
1
;
Jia LI
1
;
Yunyan PAN
1
;
Yifan ZHENG
1
;
Pan CHEN
1
;
Jie CHEN
1
Author Information
1. 中山大学附属第一医院药学部，广州 510080
- Publication Type:Journal Article
- Keywords:
Anticoagulants;
Adverse drug reaction reporting systems;
United States Food and Drug Administration;
Signal processing, computer-assisted;
Edoxaban
- From:
Adverse Drug Reactions Journal
2022;24(7):347-352
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the risk signals of edoxaban-related adverse reactions and provide reference for the clinical safety of edoxaban.Method:The US FDA adverse Event Reporting System database was searched and the adverse event (AE) reports on edoxaban as the suspicious drug from the second quarter of 2011 to the first quarter of 2022 were collected. An AE with reports>3, 95% confidence interval ( CI) lower limit of ROR>1, PRR>2, and χ2>4 was defined as a positive signal. AEs were counted and classified using the preferred term (PT) and system organ class of Medical Dictionary for Regulatory Activities 25.0. The PTs of top 50 in AE report amount and signal intensity were selected and analyzed. Results:A total of 4 113 AE reports on edoxaban as the suspicious drug were collected and 996 PTs were involved. After calculation using ROR and PRR methods, 158 positive risk signals were obtained, involving 1 898 AE reports. PTs of the top 50 in AE report amount and signal intensity were merged 89 PTs were selected after screening out duplicates, involving 1 468 AE reports. The top 5 PTs in report amount were dyspnea, anemia, atrial fibrillation, melena, and cardiac failure; the top 5 PTs in signal intensity were angiodysplasia, urogenital haemorrhage, cardiac amyloidosis, chorea, and ischaemic cerebral infarction/cardioactive drug level increased. Fourty-five PTs were not included in the drug labels. Of them, acute renal injury, renal impairment, and interstitial lung disease were with more AE reports and stronger signals. Conclusions:Bleeding-related events are still the key AEs that need to be monitored during the use of edoxaban. Edoxaban may also lead to renal injury and interstitial lung disease, which requires special attention.
