Vascular endothelial growth factor receptor tyrosine kinase inhibitors associated hepatotoxicity: An Analysis of the FDA Adverse Event Reporting System

Abstract

Abstract Vascular endothelial growth factor tyrosine kinase inhibitors (VEGFR-TKIs) are widely used in cancer. Despite the growing number of reported cases of hepatotoxicity resulting from the use of these drugs, there is a lack of information regarding the specific features and severity of hepatotoxicity associated with VEGFR-TKIs. We conducted disproportionality analyses using the Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate the potential association between hepatotoxicity and ten VEGFR-TKIs. The reporting odds ratios (ROR) and the information component (IC) were calculated to determine the presence of signals for severe liver injury. A total of 10,236 hepatotoxicity events cases with VEGF-TKIs as primary suspected drugs were collected. Apatinib, axitinib, cabozantinib, lenvatinib, pazopanib, regorafenib, sorafenib and sunitinib generated significant signals for liver injury. Significant signals indicating severe liver injury were detected with sorafenib, regorafenib, pazopanib, sunitinib and lenvatinib. The prognosis of drug-related liver injury was poor, sometimes resulting in death.