Signal Mining of Ruxolitinib-Related Adverse Drug Events Based on the FAERS
Objective To provide a reference for the rational and safe use of ruxolitinib in the clinic.Methods Adverse drug event(ADE)reports with Ruxolitinib as the primary suspected drug from November 16,2011 to December 31,2022 in the Food and Drug Administration Adverse Event Reporting System(FAERS)were retrieved,and the ADE signals were mined by the reported odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method.Results A total of Ruxolitinib-related 13 885 ADE reports were screened,with a male-to-female ratio of 1.24∶1.North America(68.78%)was the region with the highest number of ADE reports.A total of 195 ADE risk signals were identified,involving 14 system organ classificantion(SOC),mainly including various examinations(53 signals),blood and lymphatic system diseases(45 signals),infections and infectious diseases(24 signals),etc,and the main manifestations were anemia(1 486 times),lower hemoglobin(1 330 times),and lower platelet count(1 312 times).A total of 30 infection-related signals and 20 tumor-related ADE risk signals were obtained.The top three infection signals in terms of frequency were herpes zoster(288 times),tuberculosis(127 times),and herpesvirus infection(26 times).The top three tumor signals in terms of frequency were the second primary malignant tumor(298 times),skin cancer(246 times),and squamous cell carcinoma(150 times),which were listed in the drug instructions.Conclusion The mined ruxolitinib-related ADE signals and the involved SOC are basically consistent with the drug instructions.The risk assessment of infection,skin cancer and lymphomas,as well as medication education and guidance for patients should be done before use of ruxolitinib in the clinic.During the treatment,hematologic,infection,and tumor-related indicators should be closely monitored.Measures such as adjusting the dosage and interrupting treatment should be taken to avoid the occurrence of serious ADE and to ensure the medication safety of patients.
ruxolitinibFAERSadverse drug eventsignal miningROR methodBCPNN method
万方数据
维普
