Signal mining and analysis of pomalidomide adverse events based on FAERS database
Objective To mine the adverse event signals related to pomalidomide based on the adverse reaction reports in the FAERS database,so as to provide references for clinical safe and rational drug use.Methods The data of pomalidomide in FAERS database from February 8,2013 to March 20,2024 were collected,and adverse event signal mining was carried out using the method of reported odds ratio(ROR)and Bayesian credible propagation neural network(BCPNN).Results 14 618 effective adverse event reports of pomalidomide were finally included,and 152 adverse event signals were obtained,involving a total of 17 organ system classifications(SOC).The proportion of men(50.43%)was higher than that of women(45.03%).The ages were mainly distributed in people older than 60 years(56.37%),the SOC involved mainly includes various examinations,respiratory system,chest and mediastinal diseases,blood and lymphatic system diseases,infection and infection diseases,etc.A large number of adverse event signals reported include infectious pneumonia,neutropenia,decreased white blood cell count,peripheral neuropathy,etc.New suspicious adverse reactions not recorded in the instructions of pomalidomide include human chorionic gonadotropin increased,tooth disorder,atrial rupture,clonal hematopoiesis,progressive multifocal leukoencephalopathy,and hyperintensity in brain deep nuclei,etc.Conclusion The adverse reactions related to pomalidomide discovered based on the FAERS database are basically consistent with those mentioned in the drug instructions.At the same time,there are also some newly discovered suspicious adverse reactions,which should be paid attention to in clinical medication.