Mining and Analysis of Edaravone Adverse Reaction Signals Based on FAERS Database
Objective:To analyze the signal mining of suspected adverse drug events (AE) caused by edaravone based on FDA Adverse Event Reporting System,and to provide a safe medication reference for clinical use of edaravone. Methods:The AE data of edaravone,the primary suspected drug reported in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023,were selected. The signal monitoring and data mining were carried out by using the reporting odds ratio (ROR) method and the comprehensive standard method of the British Medicine and Healthcare Products Administration (MHRA). The AE reports were classified and described by comparing the system organ classification (SOC) and preferred term (PT) of the adverse drug reaction terminology set in the Medical Dictionary of Regulatory Activities. Results:A total of 2910 research reports were included,of which 60.03％ were actively reported by consumers,and 79.66％ of the reporters were from the United States.After algorithm calculation,95 effective signals were mined,including death,fatigue and fatigue. 17 SOCs including systemic diseases;in this study,the AE signals of edaravone were more common or highly correlated,such as elevated cystatin C,thrombosis at the intubation site,ventilator dependence,etc.,and 6 new potential risk signals that were not included in the drug instructions were also found,including aphasia,speech disorder,cerebral infarction,increased energy,hemorrhagic cerebral infarction,hemorrhagic infarction. Conclusion:Through the analysis of the adverse reactions of edaravone in the FAERS database,it is suggested that the occurrence of serious adverse reactions such as respiratory failure and death should be avoided in the clinical use of the drug. At the same time,it is also necessary to pay close attention to the new potential adverse reactions that may not be indicated in the instructions.
EdaravoneAdverse drug eventsFDA Adverse Event Reporting SystemSignal mining
万方数据
维普
