Signal Mining of Adverse Drug Events of Neuraminidase Inhibitors Based on FAERS Database
Objective To provide a reference for clinic safe use of neuraminidase inhibitors.Methods The OpenVigil 2.1 platform was used to retrieve adverse drug event(ADE)reports related to three neuraminidase inhibitors(oseltamivir,zanamivir,peramivir)in the US Food and Drug Administration Adverse Event Reporting System(FAERS)from the first quarter of 2004 to the third quarter of 2022(with data for peramivir only available from 2015 to 2022).The reporting odds ratio(ROR)method and the Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive method were used to mine ADE signals,the preferred terms(PT)in the MedDRA 25.0 were used for encoding of the searched adverse drug reactions(ADRs)and the system organ classification(SOC)was used for classification.Results A total of 14 646 ADE reports were obtained with neuraminidase inhibitors as the primary suspected drug,including 12 223 reports of oseltamivir,2 377 reports of zanamivir,and 46 reports of peramivir.A total of 228 ADE signals and 15 SOCs were mined,with SOC mainly concentrated in psychiatric disorders,gastrointestinal diseases,various neurological diseases,etc.ADRs with a high frequency of occurrence included vomiting,abnormal behavior,hallucinations,insomnia,and confusion of oseltamivir,abnormal behavior,hallucinations,delirium,loss of consciousness,and changes in the consciousness of zanamivir,and shock and acute kidney injury of peramivir.ADRs with high signal intensity included infantile acne,delirium febrile,pathological personality,hemorrhagic enterocolitis,and sleep disturbances of oseltamivir,delirium febrile,febrile seizures,ocular mucocutaneous syndrome,abnormal behavior,and sleep talk of zanamivir,and shock and acute kidney injury of peramivir.Oseltamivir had insomnia,upper abdominal pain,aggression,loss of consciousness,bradycardia,and other ADRs not listed in the drug instructions.Zanamivir had loss of consciousness,decreased consciousness levels,seizures,aggression,agitation,and other ADRs not listed in the drug instructions.Conclusion When using neuraminidase inhibitors in the clinic,attention should be paid to ADRs in psychiatric,gastrointestinal,and various neurological diseases to ensure the safety of medication for patients.
neuraminidase inhibitorsFAERSadverse drug eventsreporting odds ratio methodMHRA comprehensive method
万方数据
维普
