Mining and analysis of adverse event signals of pazopanib after market launch based on the FDA adverse event reporting system database
Objective To investigate the pazopanib adverse reaction signals and offer guidance for safe clinical medication.Methods Reports about pazopanib from March 1,2017,to December 31,2022,were acquired from the Food and Drug Administrations(FDA)adverse event reporting system(FAERS),and the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were utilized for data mining.To ascertain whether a signal exists,the ROR,PRR,and 95％confidence intervals(95％CI)were calculated.The intensity of the adverse drug reaction(ADR)signal was deter-mined by comparing the ROR/PRR values with their standard errors.Results After calculations using the ROR and PRR formulas,both methods identified 376 adverse reaction signals for pazopanib.After a second screening and the exclusion of signals potentially caused by ineffective tumor treatment,a final total of 184 completely overlapping signals were ob-tained.Involving 16 systems,systemic diseases and various reactions at the administration site,gastrointestinal diseases,and various examinations had a higher incidence of adverse reactions.Among benign,malignant,and unknown tumors,52.68％(1 653/3 138)had metastasized.The frequency of adverse reactions was mainly concentrated in death,diarrhea,hypertension,fatigue,and nausea and vomiting,while those with strong signals mainly occured in skin and subcutaneous tissue diseases.At the same time,57 adverse reactions were found that were not included in the instructions,such as ex-ophthalmos,hypoproteinemia,hemoptysis,food intolerance,and caval vein thrombosis,etc.Conclusions Through the ROR and PRR signal detection methods,57 new adverse reaction signals not mentioned in the pazopanib product leaflet were identified and should be paid attention to.It is recommended that healthcare professionals consider the possible ad-verse reactions caused by pazopanib and take intervention measures when using the drug clinically.
pazopanibFood and Drug Administration adverse event reporting systemproportional reporting ratio meth-odadverse drug eventssignal mining
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