Mining and analysis of adverse event signals of selexipag based on FDA adverse event reporting system database
Objective To mine and analyse the potential adverse event(ADE)risk signals of selexipag post-marketing to provide a reference for its rational clinical application.Methods The FDA adverse event reporting system database of ADEs reported for selexipag from marketing(December 2015)to November 2023 was extracted to conduct data cleaning de-duplication and standardization.Signal mining was performed using the reported ratio(ROR)and Bayesian confidence progressive neural network(BCPNN)methods.Results A total of 100 07 ADEs were reported in the database with selexipag as the primary suspect.Mining by ROR and BCPNN methods resulted in 325 potential positive PTs,involving 19 SOCs,among which the ADEs reports associated with general disorders and administration site conditions diseases were the most(17.24%),followed by gastrointestinal system diseases(13.62%),respiratory system,chest and mediastinal diseases(10.86%),nervous system disease(10.17%),musculoskeletal and connective tissue diseases(9.30%),various abnormal examination indicators(6.61%),infectious diseases(5.23%)Compared with the drug instructions,it was found that 301 kinds of PT were not recorded in the drug instructions,such as dyspnea,elevated pulmonary artery pressure,fatigue,heart failure and so on,which require high clinical attention.Conclusion Mining the real-world adverse events of selexipag suggests that clinical caution should be given in evaluating its ADE risk factors and strengthening the medication monitoring to ensure patient medication safety.
selexipagFDA adverse event reporting systemprostacyclin receptor agonistsignal miningadverse drug event
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