Signal Mining and Analysis of Oseltamivir-Related Adverse Drug Events in Children Based on FAERS
Objective To provide a reference for the safe use of oseltamivir in the clinic.Methods Adverse drug event(ADE)reports with oseltamivir as the primary suspected drug and occurring in children aged 0-17 years old from the first quarter of 2004 to the first quarter of 2023 in the Food and Drug Administration Adverse Event Reporting System(FAERS)database were retrieved,and the ADE signals were mined by the reported odds ratio(ROR)method and proportional reporting ratio(PRR)method.The preferred technique(PT)and preferred system organ classification(SOC)from the International Dictionary of Medical Terminology were used for encoding and classification.Results A total of 3 100 oseltamivir-related reports were mined,with 76 positive signals detected,mainly concentrated in 12 SOC categories including psychiatric disorders(34 signals),various nervous system disorders(13 signals),gastrointestinal disorders(seven signals),general disorders and administration site conditions(six signals),and immune system disorders(three signals).The top 20 ADEs in terms of frequency were hallucinations(455 times),abnormal behavior(428 times),vomiting(410 times),delirium(120 times),and confusional state(111 times).The top 20 ADEs in terms of signal strength were psychiatric disorders,nervous system disorders,and gastrointestinal disorders.The top 20 ADEs in terms of frequency and signal strength were screaming,fear,and sleep terror,which were not listed in the drug instructions.Conclusion When using oseltamivir in the children in the clinic,attention should be paid to ADEs related to psychiatric disorders,nervous system disorders,gastrointestinal disorders,and skin and eye.
oseltamivirchildrenFAERSadverse drug eventssignal mining
万方数据
维普
