Safety study of anti-influenza virus drugs baloxavir marboxil and oseltamivir based upon real-world data
OBJECTIVE To explore the safety differences of baloxavir marboxil and oseltamivir to provide references for post-marketing research and clinical rational drug use.METHODS The adverse events of baloxavir marboxil and oseltamivir reported in FDA Adverse Event Reporting System(FAERS)from quarter Ⅰ of 2019 to quarter Ⅲ of 2022 were retrieved with reporting odd ratio(ROR)and Bayesian confidence propagation neural network(BCPNN).RESULTS ADE signals of baloxa-vir marboxil and oseltamivir involved multiple systems.Different from the signals of congenital familial genetic disorder,reproduc-tive system and breast diseases unique to oseltamivir,baloxavir marboxil as a primary suspect drug has unique signals of kidney and urinary system diseases.In system organ class(SOC)with signals for both drugs,obvious differences existed in AED signal intensity in psychiatric diseases,pregnancy/puerperium/perinatal conditions,ocular organ diseases and various nervous system dis-eases.Baloxavir marboxil reported the most number of no adverse event signals while oseltamivir yielded the most number of vom-iting signals.CONCLUSION ADE signals obtained in this study are consistent with the existing common ADRs in package insert.However,significant differences exist in system organs and signal intensity of pregnancy/postpartum/perinatal conditions,congenital familial genetic diseases,ocular organ diseases,kidney and urinary system diseases.For population at a high risk of ADE as mentioned above,this study provides references for individualized drug selections and ensuring clinical safety and rational drug use.
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