Disproportionality Analysis of Lenvatinib‐Caused Gastrointestinal Perforation in Cancer Patients: A Pharmacovigilance Analysis Based on the US Food and Drug Administration Adverse Event Reporting System

• DOI: 10.1002/jcph.2312
• Publication Date: 2023-07-21T00:18:52Z
• Authors: Jianxing Zhou; Zipeng Wei; You Zheng; Helin Xie; Wanxia Cao; Xinying Cai; Jialin Huang; Xuemei Wu
• Keywords: Gastrointestinal perforation; Perforation; Lenvatinib; Gastrointestinal cancer

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