Evaluating safety risks of ischaemic colitis with taxanes: a disproportionality analysis based on FDA adverse event Reporting system

Ischaemic colitis (IC) is a rare yet serious gastrointestinal condition, increasingly reported in patients receiving taxanes-based chemotherapy. So far, the correlation between the two remains unclear. The aim of this study is to assess the safety concerns associated with taxanes use in relation to IC. Disproportionality analyses (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], Multi-item gamma Poisson Shrinker [MGPS]) were conducted using the FDA Adverse Event Reporting System (FAERS, 2005 Q1-2023 Q2). Significant IC signals were detected across taxanes: paclitaxel (ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05), nab-paclitaxel (ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,), and docetaxel (ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59). Reports were predominantly from Japan and the U.S.A. with IC developing within 16 days in half of the patients. Taxanes may substantially increase IC risk, necessitating vigilant gastrointestinal monitoring and characterization of high-risk populations. Further clinical validation is required to confirm these findings.