Gastrointestinal perforation associated with novel antineoplastic agents: A real-world study based on the FDA Adverse Event Reporting System

Abstract

Purpose: Gastrointestinal perforation (GIP) is a fatal adverse event (AE). The AE of GIP induced by novel antineoplastic agents has attracted attention recently. We aimed to explore the AE signals of GIP related to novel antineoplastic agents comprehensively based on the FDA Adverse Event Reporting System (FAERS).Methods: The FAERS database containing 71 quarters of records was used for analysis. Reporting odds ratio (ROR), information component (IC), and empirical Bayesian geometric mean (EBGM) were utilized to evaluate the signals of GIP associated with novel antineoplastic drugs. Standardization of drug names was by employing MedEx-UIMA software and Python. Data analysis and visualization were performed using MySQL Workbench and R software.Results: After cleaning and handling the data, 5226 GIP cases were identified that were associated with new antineoplastic medications, where these agents were the main suspected contributors. A total of 37 novel antineoplastic drugs were detected with signals of GIP for ROR and IC. Only 22 drugs showed statistically significant signals for EBGM. We found the GIP signals of 22 novel antineoplastic drugs overlapped for the 3 indicators, including anti-vascular endothelial growth factor/vascular endothelial growth factor receptor, anti-endothelial growth factor receptor, immune checkpoint inhibitors, and so on.Conclusion: The potential risk of GIP associated with several novel antineoplastic agents was identified through data mining, which provided valuable information on the safety risks associated with GIP among these drugs. The potential threat of GIP should be recognized and managed properly when using these novel antineoplastic agents.

A Rare Presentation of Small Bowel Perforation Secondary to Microscopic Metastasis of Non-small Cell Lung Cancer (NSCLC): A Case Report

“…Only one of them presented with an acute abdomen. GITP has been associated with several novel antineoplastic agents, including anti-VEGF/VEGFR, anti-EGFR drugs, and immune checkpoint inhibitors (ICIs) [ 10 ]. Tumor immunotherapy, particularly with a focus on immune checkpoint inhibitors, has gained prominence in the field of oncology [ 11 ].…”

“…Proposed theories include suspicion of bowel ischemia due to decreased vascular supply and cytokine-induced immune-related adverse events [ 12 ]. Bowel perforation related to durvalumab has also been documented in medical literature [ 10 ]. However, establishing an association between GITP and durvalumab in our case remains uncertain due to the current micro-metastasis of NSCLC at the perforation site.…”

A real-world pharmacovigilance analysis for transthyretin inhibitors: findings from the FDA adverse event reporting database

“…We obtained reports of AEs caused by TTR inhibitors as the primary suspect (PS) drug from the first quarter of 2018 to the third quarter of 2023 by searching for patisiran (ALN-TTR02, onpattro, patisiran sodium), vutrisiran (amvuttra, vutrisiran sodium), and inotersen (inotersen sodium, tegsedi) in the FAERS database. Secondly, we removed duplicates based on CASEID, FDA_DT, and PRIMARYID in the FAERS database, as demonstrated in Table 1 ( Yu et al, 2023 ). Finally, we analyzed the data based on the hierarchical structure of the International Medical Dictionary (MedDRA) version 26.1, from the SOC and the PT levels ( Brown, 2002 ; Brown, 2003 ).…”