Safety assessment of aspirin in anti-tumor therapy based on FAERS
HUANG Li
WU Wenke
HU Ge
Abstract：Objective To identify adverse event(AE)signals associated with aspirin use in anti-tumor therapy based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS),so as to provide references for the safe clinical use of drugs.Methods AEs related to aspirin use in anti-tumor therapy reported in FAERS from 2004 to the third quarter of 2024 were extracted,with"Aspirin"and"Acetylsalicylic Acid"as the main suspect drug crite-ria for screening.The screened AEs were classified and described using the System Organ Classes(SOCs)and Preferred Terms(PT)from the Medical Dictionary for Regulatory Activities(MedDRA v27.1).The onset time of AEs associated with aspirin use in anti-tumor therapy was calculated using R language(R4.4.2).Positive signals of AEs related to aspi-rin in anti-tumor therapy were detected using reporting odds ratio,proportional reporting ratio(PRR),Medicines and Healthcare products Regulatory Agency(MHRA),and Multi-item Gamma Poisson Shrinker(MGPS).Results A total of 107 AE reports were obtained,with the largest number reported in the United States.After removing duplicate and er-roneous reports,only 23 reports provided the onset time,with a median onset time of 460 days.A total of 16 positive sig-nals were detected,involving 8 SOCs.The top three SOCs with the highest signal intensity for AEs related to aspirin use in anti-tumor therapy were pregnancy,puerperium and perinatal conditions,vascular and lymphatic system disorders,and blood and lymphatic system disorders.The PTs with relatively high signal intensity included off-label medication er-rors related to drug-drug interactions as specified in the package insert,subarachnoid hemorrhage,subdural edema,ce-sarean section,and intracranial hemorrhage,and others.Conclusion There is a relatively high incidence of off-label use of aspirin in anti-tumor therapy,and it may increase the risk of intracranial bleeding.
Keywords：aspirintumoradverse eventFood and Drug Administration Adverse Event Reporting System
Publication Date：2025-08-25
Online Publishing Date：2025-09-10(First online date of this platform, not the publication date of the document)
Pages：5( 31-35 )