Toward the future management of patients with CML and Ph + ALL: real-world safety insights from dasatinib pharmacovigilance.

ABSTRACT:

Background

Dasatinib, a second-generation BCR-ABL1 tyrosine kinase inhibitor, has transformed treatment for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. However, its broad kinase inhibition leads to distinct adverse events (AEs), requiring systematic post-marketing surveillance.

Objective

To evaluate dasatinib-associated AEs using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and identify potential safety signals.

Methods

We extracted FAERS reports (Q1 2004-Q4 2024) listing dasatinib as the primary suspect drug, submitted by physicians or pharmacists. After data cleaning, AEs were coded using MedDRA terminology. Signal detection was performed with four disproportionality methods (RO

SUBMITTER: Lu Z 

PROVIDER: S-EPMC12815812 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature