FDA adverse event reporting system database-based study of adverse events associated with baloxavir marboxil in a pediatric population
Objective To explore adverse events of baloxavir marboxil in the pediatric population using the U.S.FDA adverse event reporting system(FAERS)database to inform safe medication use in children.Methods The FAERS database was searched for reports of adverse events in the pediatric population from the first quarter of 2018 to the first quarter of 2024 in which baloxavir marboxil or Xofluza® was the primary suspect.The reports were analyzed by reporting odds ratio and Bayesian confidence propagation neural network.Results A total of 424 reports of adverse events in children with baloxavir marboxil as the main suspect were screened.There were slightly more males(42.69%)than females(38.68%),children aged 5 to 11 years accounted for 71.93%.The main reporting country was the United States(73.82%),serious adverse event outcomes accounted for 31.60%,and the main reporting years were centered on 2019 and 2020,with 27.83%and 58.25%,respectively.The safety signals detected involved seven system-organ classes.According to the signal frequency distribution,the adverse events associated with baloxavir marboxil in the pediatric population were abnormal behavior,delirium,and rapid-onset severe allergic reactions in order of magnitude.According to the signal intensity,the intensity was in order of thermal delirium,erythema multiforme,delirium,etc.Adverse event signals not included in the Instructions for baloxavir marboxil were detected including thermal delirium,dehydration,altered state of consciousness,and facial edema.Conclusion Baloxavir marbaoxil has been associated with adverse reactions such as psychiatir system symptoms and allergic reactions.Therefore,special attention should be paid to the occurrence of psychiatric symptoms such as abnormal behavior and febrile delirium when using baloxavir marboxil in children to ensure the safety.
baloxavir marboxilchildrenFDA adverse event reporting system databaseinfluenzapharmacovigilancemedication safety
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