Safety assessment of eltrombopag:real-world adverse event analysis from the FAERS database
LIU Jie
CHEN Shupeng
GAO Yao
ZHANG Meiling
WU Zhenhui
ZENG Yingjian
Abstract：Objective To detect and analyze the signals of spontaneously reported adverse drug events(ADE)in the post-marketing clinical application of eltrombopag by data mining technology,so as to deepen the systematic understanding of the safety characteristics of eltrombopag.Methods This study conducted a systematic search of the Food and Drug Administration Adverse Event Reporting System database operated by the US Food and Drug Administration from the date of entry(December 31,2008)to June 30,2024.After standardizing the data,four non-proportional methods,namely reporting odds ratio(ROR),proportional reporting ratio,Bayesian confidence propagation neural network and multi-item gamma Poisson shrinker,were used to evaluate the correlation between eltrombopag and ADE,and Weibull shape parameter was used to analyze the characteristics of the onset time curve to explore the ADE signals of eltrombopag.Results There were 17 230 ADE reports of eltrombopag.A total of 182 preferred terms(PT)showed significant disproportionality across all four algorithms and seven system organ classes(SOC)showed significant disproportionality across any four algorithms.SOC disproportionate analysis found that"general disorders and administration site conditions"were significant and ranked first in the total number of ADE cases(n=8 985,ROR=1.28).PT analysis revealed high-intensity ADE signals associated with eltrombopag,such as decreased platelet count and elevated platelet count.Some ADE signals were found to be highly consistent when compared with drug instructions and Side Effect Resource databases,while some new ADE signals were also found.Conclusion More attention should be paid to the risks of"thrombocytopenia"and"anemia"when taking eltrombopag.At the same time,we should also be alert to cerebral infarction and myocardial infarction events caused by thrombosis due to increased platelets,as well as ADE signals not mentioned in the instructions,such as"antiphospholipid syndrome"and"increased reticulocyte count",to ensure the medication safety of patients.
Keywords：eltrombopagFAERS databaseadverse event signaldisproportionate analysisreal-world researchimmune thrombocytopenia
Publication Date：2025-11-30
Online Publishing Date：2026-08-26(First online date of this platform, not the publication date of the document)
Pages：9( 1456-1464 )