Signal mining and analyses of adverse drug reactions for brigatinib based upon FAERS
OBJECTIVE To provide clinical safety supports for brigatinib through mining its potential adverse drug reaction signals.METHODS Based upon the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),adverse drug event(ADE)data of brigatinib were retrieved from the listing date to the second quarter in 2023.Proportional imbal-ance method was utilized for examining the extracted data.The potential adverse drug reaction signals were identified along with ADEs in package insert and case reports in the literature.RESULTS A total of 2 521 ADE reports related to brigatinib as a pri-mary suspect drug were extracted.There was a higher proportion of females(49.35％)than males(38.52％).The age groups were distributed between 41 to 65 years(29.27％)and over 65 years(21.98％).The reporting years were largely clustered after 2018.There was a yearly rising trend and the major reporting country was United States(49.66％).A total of 72 effective ADE signals were identified.Diarrhea,nausea,elevation of blood creatine phosphokinase and cough were frequent.It was consistent with the descriptions of package insert.CONCLUSION This study has identified 34 new potential ADEs based upon package insert of brigatinib.It offers suggestions for off-label usage and dosage adjustments to ensure patient safety.
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