Signal mining and analysis of filgrastim adverse events based on FAERS database
Objective To excavate and analyze the safety signals of filgrastim related adverse events,and to provide reference for the safe clinical use of filgrastim.Methods To collected adverse events of filgrastim from FAERS from January 1,2013 to December 31,2023.Subsequently signals mining were carried out by using the ROR,PRR and BCPNN methods.Statistical analysis was carried out to reveal the top 20 frequent reports and intensive signals,and adverse events classified by various systems and organs.Results A total of 4 434 adverse event reports related to filgrastim were collected,and 328 related signals were found.Fever,bone pain and decreased white blood cell count were common.A total of 22 systemic organs are involved,mainly focusing on diseases of the blood and lymphatic system,infections and infectious diseases,and various examinations.78 new suspected adverse reactions not recorded in the instructions were found,mainly sepsis,malignant tumor and inadequate bone integration.Conclusion The common adverse reactions of fegelstim in the real world are consistent with the instructions,but there are some newly found suspicious adverse reactions.It is recommended to pay close attention to clinical drug use,do a good job of risk assessment before drug use,and timely monitoring after drug use to ensure the safety of drug use for patients.
filgrastimFAERS databaseadverse drug eventssignal miningproportional imbalance methoddiseases of blood and lymphatic system
NETL
NSTL
万方数据
