Objective To detect and analyze the adverse drug event(ADE)signals of prasugrel since its launch,and provide a basis for its clinical rational use.Methods ADE reports of prasugrel from January 1st,2009 to January 30th,2023 were collected from the OpenFDA database.The reporting odds ratio(ROR)method was used for signal detection.According to the Medical Dictionary for Regulatory Activities(MedDRA),each signal was mapped onto its corresponding system organ class(SOC),and compared and analyzed with adverse reactions in the prasugrel package insert.Results A total of 10 872 ADE reports of prasugrel were extracted,in which 44 effective signals involving 11 types of SOC were detected.There were 23 potential adverse reaction signals that had been not recorded in the package insert.Conclusion At present,prasugrel was considered safe.However,it was necessary to pay close attention to and evaluate the risk of adverse events such as gastrointestinal disorders,vascular pseudoaneurysm,cardiac diseases,and renal and urinary disorders during the clinical use of prasugrel.
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