Study On FDA Signal Detection Of Atomoxetine Based On The US Openfda Database

In the 1960 s,thalidomide adverse drug reaction events shocked the world,which promoted drug regulatory authorities of various countries to establish pharmacovigilance systems,including the establishment of an adverse drug reaction information database to collect and manage adverse drug event reports.At present,studies on adverse reactions of atomoxetine hydrochloride at home and abroad mainly include the comparative study of certain types of adverse events of the drug,the retrospective analysis of literature,or the collection of safety information through clinical trial studies.At present,most studies are on common adverse reactions to the drug.Atomoxetine hydrochloride has been on the market in the United States for nearly 20 years,and there is a lack of complete analysis and study of adverse drug event reports in the FDA adverse events database.In this context,to supplement the adverse reaction research information of this drug and provide data support for further confirmation of drug safety,this paper mined and analyzed the adverse events of atomoxetine hydrochloride in the adverse reaction database of the US FDA.The specific research contents include:(1)Classify the data in atomoxetine adverse event reports in the database,analyze and summarize the classification variables of each group by statistical description analysis method,and obtain the differences in the incidence of adverse events in terms of gender and system organs,which will help to analyze safety risk and new research directions.(2)PRR method was used for data analysis of atomoxetine adverse events.This method has high sensitivity and can detect and identify multiple suspicious signals of adverse reactions,significantly more than the number of adverse reaction signals currently reported,providing data support for the subsequent confirmation of drug safety.(3)ROR method was used for data analysis of atomoxetine adverse events.This method has high stability and generally,no bias occurred in detection results.The results showed that the results of the two analysis methods were highly consistent,which verified the applicability of the PRR method and provided the reference for subsequent studies.It is also suggested that adverse events in different databases can be further studied,and other detection methods can be used to mine safety signals and confirm suspicious signals of adverse reactions based on this study.