Disproportionality Analysis of Lenvatinib-caused Gastrointestinal Perforation in Cancer Patients: A Pharmacovigilance Based on the Food and Drug Administration Adverse Event Reporting System.

Lenvatinib is a medication that targets multiple tyrosine kinases and is commonly used to treat various types of cancer. Due to its frequent usage, monitoring and assessing its potential adverse effects has become crucial. This study utilizes the FAERS database to analyze the possible link between lenvatinib and gastrointestinal perforation (GP). The FDA Adverse Event Reporting System was used to analyze adverse drug reactions linked with lenvatinib from Q1 2015 to Q4 2022. The association between lenvatinib and gastrointestinal perforation was evaluated using disproportionality Analyses. This study included 464 patients who developed gastrointestinal perforation after using lenvatinib. The perforation involved the entire digestive tract, the colon was among the most commonly affected perforation sites, and previously undetected esophageal perforation was frequently observed. Uterine and liver cancer patients were at a higher risk of developing gastrointestinal perforation, with liver cancer patients experiencing a shorter onset time and those with endometrial cancer displaying a slower time to onset. Middle-aged and elderly patients exhibited a higher propensity for developing gastrointestinal perforation than younger adults. Patients with gastrointestinal perforation were found to have a significantly higher mortality rate than those without gastrointestinal perforation. This study has identified several gastrointestinal perforation events not included in the drug instructions. It has also described the perforation site and clinical characteristics based on various types of cancer. These results could provide valuable insights for developing safer and more effective regulatory strategies concerning the use of lenvatinib. This article is protected by copyright. All rights reserved.