A real-world pharmacovigilance analysis of FDA adverse event reporting system database for baloxavir marboxil

Abstract

Abstract Baloxavir marboxil represents a groundbreak drug as the premiere agent targeting influenza with an innovative mechanism of action. The study was to investigate the adverse events and provide reference for clinical safety. The adverse events data were collected from the U.S. FDA Adverse Event Reporting System (FAERS) database covering the first quarter of 2018 to the third quarter of 2023. Two methods, reporting odd ration (ROR) and bayesian confidence propagation neural network (BCPNN) were used to detect the adverse events risk signal. A total of 1671 adverse events reports with baloxavir marboxil as the main suspected drug were collected. More women and patients under 18 years of age were reported. It was found that the adverse events signals involved multiple systems, among which the high-risk signals included melena, altered state of consciousness, delirium, abnormal behavior, rapid severe anaphylaxis, anaphylactic shock and erythema multiforme. Safety warning signs of ischemic colitis and rhabdomyolysis, which were high risk and not mentioned in the instructions, were also detected. In addition to the adverse events recorded in the manual, ischemic colitis, neuropsychiatric symptoms, allergic reactions, severe skin adverse reactions and rhabdomyolysis in the clinical application of baloxavir marboxil also should be paid attention to ensure the safety of patients.