Unveiling unexpected adverse events: post-marketing safety surveillance of gilteritinib and midostaurin from the FDA Adverse Event Reporting database.

ABSTRACT:

Background

Gilteritinib and midostaurin are FLT3 inhibitors that have made significant progress in the treatment of acute myeloid leukemia. However, their real-world safety profile in a large sample population is incomplete.

Objectives

We aimed to provide a pharmacovigilance study of the adverse events (AEs) associated with gilteritinib and midostaurin through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.

Design

A retrospective analysis of the FAERS database was conducted by disproportionality analyses.

Methods

We conducted disproportionality analyses to identify drug-AE associations, including the reporting odds ratio and the Bayesian confidence propagation neural network. A signal was detected if both methods achieved

SUBMITTER: Jiang T 

PROVIDER: S-EPMC11724423 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature