摘要
Abstract
AIM The potential adverse drug event(ADE)signals associated with vonoprazan were detected and analyzed using the Japanese Adverse Drug Event Report(JADER)database,to provide references for its rational and safe clinical use.METHODS The vonoprazan-related ADE reports in the JADER database from December 2014 to December 2023 were analyzed using the report odds ratio method and the comprehensive standard method from Medicines and Healthcare products Regulatory Agency(MHRA).RESULTS A total of 2 192 cases of vonoprazan-related ADE reports were analyzed,and 57 disproportionality signals were detected,involving 13 system organ classes.The ADE signals were primarily concentrated in gastrointestinal,skin,subcutaneous tissue and hepatobiliary disorders.Among these,strong ADE signals such as hypergastrinemia,gastric mucosal hypertrophy,elevated blood gastrin,Wernicke-Korsakoff syndrome,and eosinophilic cystitis were identified,which were not documented in the drug label.CONCLUSION The newly detected ADE signals in this study supplement current safety information in the drug label.Additionally,the understanding of drug safety in the Asian population is improved and the drug safety of patients is guaranteed by mining the JADER database.关键词
伏诺拉生/药品不良事件/日本药品不良事件报告数据库/信号挖掘Key words
vonoprazan/adverse drug events/Japanese Adverse Drug Event Report datebase/signal mining分类
药学
