Thyroid dysfunction related to vascular endothelial growth factor receptor tyrosine kinase inhibitors: A real‐world study based on FAERS.

What is known and objective: The adverse events of thyroid dysfunction caused by the use of vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR‐TKIs) have not been confirmed in a real‐world investigation. The aim of this study was to evaluate the relationship between thyroid dysfunction and treatment using Food and Drug Administration (FDA)‐approved VEGFR‐TKIs. Methods: Four data‐mining algorithms were employed to detect thyroid dysfunction signals for VEGFR‐TKIs, using data in the FDA Adverse Event Reporting System (FAERS) database from 68 quarters. MySQL Workbench and R were used to conduct statistical analysis. Results and Discussion: We identified 32679 reports of thyroid dysfunction, of which 1567 listed VEGFR‐TKIs as the primary suspected drugs. All four algorithms showed that the strength of the signals for hypothyroidism were greater than those for hyperthyroidism, for all the VEGFR‐TKIs. In most cases, the median appearance time was within 100 days of initiation of VEGFR‐TKIs therapy, except in the case of ponatinib. This indicated the need to actively identify and manage thyroid dysfunction during the early stages of VEGFR‐TKIs treatment. What is new and conclusions: This study systematically identified the pharmacovigilance signals of thyroid dysfunction associated with the use of VEGFR‐TKIs, using the FAERS database. [ABSTRACT FROM AUTHOR]