Iodine contrast medium-associated thyroid dysfunction:a real-world signal mining study
OBJECTIVE To comprehensively mine the adverse event(thyroid dysfunction)signals of global marketed iodine contrast media,so as to provide reference for safe clinical use.METHODS The reports in the U.S.FDA Adverse Event Reporting System(FAERS)database were obtained.Disproportionality methods were used to detect the signals of thyroid dys-function caused by iodine contrast media,and demographic information,time to onset and patient outcome were analyzed.RESULTS Six iodine contrast media including iohexol,iopamidol,iopromide,ioversol,iodixanol and meglumine diatrizoate have been reported.Iohexol,iopamidol and iopromide had no hypothyroidism signal,and iodixanol had the highest signal inten-sity.Hypothyroidism mainly occurred in infants and females,while hyperthyroidism mainly occurred in adults and males.The time to onset was concentrated in the first 30 days.The proportion of serious outcomes was significantly higher in hyperthyroidism than that in hypothyroidism(P<0.01).CONCLUSION Different iodine contrast media may have different risks of thyroid dys-function.The incidence of iodine contrast medium-associated hypothyroidism and hyperthyroidism differs according to age and gen-der,while the occurrence of them is usually within the first 30 days,and thyroid surveillance is recommended during this time for high-risk individuals.Hyperthyroidism may lead to more severe outcomes.