Signal Mining of Adverse Drug Reaction Related to Anaplastic Lymphoma Kinase Inhibitors After Marketing Based on FAERS
Objective To compare the safety of five kinds of anaplastic lymphoma kinase inhibitors(ALKi).Methods Report odds ratio(ROR)method was used to mine the risk signals of the key adverse drug reactions(ADRs)reports of five ALKi(Crizotinib,Alectinib,Ceritinib,Brigatinib,and Lorlatinib)in gastrointestinal,hepatobiliary,urinary,respiratory,nutritional/metabolic and neurological systems in the FDA Adverse Event Reporting System(FAERS)as of November 31,2022.Results A total of 15 234 055 ADR reports were mined,including 20 181 ALKi-related ADR reports.Among them,10 958,4 229,2 101,1 802,and 1 091 cases were reported for Crizotinib,Alectinib,Ceritinib,Brigatinib,and Lorlatinib,respectively.Alectinib,Ceritinib and Crizotinib showed relatively high risk signal in tensity in gastrointestinal system-related ADRs.Alectinib and Ceritinib were more likely to show risk signals in hepatobiliary system-related ADRs than other ALKi,and no urinary system-related risk signals were found for all five ALKi.Lorlatinib showed relatively high risk signal intensity in nutritional/metabolic systems.Four ALKi(except for Lorlatinib)showed relatively strong risk signal intensity in respiratory system-related ADRs,while Loratinib showed relatively high risk signal intensity in nervous system-related ADRs.Conclusion The risk signal strength of five Alki-related ADRs is basically consistent with the clinical study results.Data mining on FAERS can understand the real incidence of ALKi-related ADRs after the marketing,and provide a reference for the clinical medication.
anaplastic lymphoma kinase inhibitorsFAERSadverse drug reaction signaldata mining
万方数据
维普
