Safety profiles of dasatinib in pediatric patients - A real-world pharmacovigilance assessment based on the FAERS database

Sep 30, 2026

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Objective: Dasatinib was approved for pediatric Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia, yet comprehensive safety evidence in children remains limited. This study used FAERS adverse event reports to evaluate and characterize pediatric AEs associated with dasatinib. Methods: FAERS data from 2014 Q1 to 2024 Q4 were analyzed using disproportionality methods to identify reported AEs. Results: 382 pediatric cases were analyzed, with frequent system organ classes including general disorders and gastrointestinal disorders; several previously unreported AEs and off-label use patterns were detected, suggesting new safety concerns. Conclusion: Findings support enhanced pediatric pharmacovigilance and proactive monitoring to improve treatment safety and outcomes.

LanguageEnglish

CategoryHealthcare

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Abstract

Introduction

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Safety proﬁles of dasatinib in pediatric patients: areal-world pharmacovigilance assessment based on the FAERS database Yuanyuan Yang , Weihao Ma, Hongbo Fu, Yanqiong Zhou, Yan Lin* Department of Pharmacy of the Second Afﬁliated Hospital, Shantou University Medical College, No. 69 Dongxia North Road, Jinping District, Shantou 515041, Guangdong, China *Corresponding author. Department of Pharmacy of the Second Afﬁliated Hospital, Shantou University Medical College, No. 69 Dongxia North Road, Jinping District, Shantou 515041, Guangdong Province, China. E-mail: [214636852@qq.com](214636852@qq.com) Abstract Objective: Dasatinib was approved for treating pediatric patients with philadelphia chromosome-positive chronic myeloid leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia. While its efﬁcacy has been proven, comprehensive safety data in pediatric populations remain limited. This study utilizes data from the food and drug administration adverse event reporting system (FAERS) to evaluate and characterize adverse events (AEs) reported in pediatric patients treated with dasatinib. Methods: Data from the FAERS between 2014 Q1 and 2024 Q4 were analyzed. Disproportionality analysis was performed to identify AEs reported in pediatric patients treated with dasatinib. Results: A total of 382 pediatric cases involving dasatinib were reported. The most frequent system organ classes included general disordersand administration site conditions, injury, poisoning, and procedural complications, and gastrointestinal disorders. Notably, previously unreported AEs such as hemorrhagic enterocolitis, lymphoid tissue hyperplasia, hydrocephalus, and hemorrhagic cystitis were identiﬁed, raising potential new safety concerns. Additionally, instances of off-label use were observed, particularly in regions where dasatinib is not recommended for pediatric patients, underscoring the importance of vigilant AEs monitoring to ensure patient safety. Conclusion: This study highlights the need for enhanced pharmacovigilance and proactive monitoring in pediatric patients receiving dasatinib to ensure treatment safety and improve clinical outcomes, and provides supporting evidence for the safe use of dasatinib in pediatric populations. Keywords: adverse events; dasatinib; FAERS; pediatric patients; pharmacovigilance Introduction Philadelphia chromosome-positive chronic myeloid leukemia (Ph + CML) and philadelphia chromosome-positive chronic myeloid leukemia (Ph + ALL) are rare but aggressive hematologic malignancies in pediatric patients, characterized by the BCR-ABL fusion gene resulting from a chromosomal translocation [1, 2] . Pediatric Ph + CML often exhibits more aggressive clinical features and unique biological behavior compared to adult cases, including distinct mutational profilesand treatment responses [3] . Although Ph + ALL accounts for only a small proportion of childhood ALL, it carries a poor prognosis, with event-free survival (EFS) rates as low as 25%–30%[4, 5] . The introduction of tyrosine kinase inhibitors (TKIs) has substantially improved survival in these populations [6] . Dasatinib, a second-generation TKI, offers more potent and rapid molecular responses than imatinib, and is approved for use in pediatric patients with newly diagnosed or imatinibresistant/intolerant Ph + CML, as well as Ph + ALL [7, 8] . Its favorable pharmacokinetic profile—including oncedaily dosing and blood–brain barrier penetration, makes it particularly suitable for pediatric use, especially in cases with central nervous system (CNS) involvement [9–12] . Notably, a randomized trial demonstrated superior efficacy of dasatinib over imatinib in pediatric Ph + ALL, with higher 4-year EFSand overall survival (OS) rates and a lower risk of relapse [11] . Despite its efficacy, dasatinib has been associated with various adverse events (AEs), such as cytopenias, pleural effusion, and gastrointestinal disturbances, which are

FAQs

What was the main objective of the study on dasatinib safety in children?

To evaluate and characterize adverse events reported in pediatric patients treated with dasatinib using FAERS data.

How were adverse events identified and assessed in the analysis?

FAERS reports from 2014 Q1 to 2024 Q4 were analyzed, and disproportionality analysis was used to identify AEs reported in pediatric patients treated with dasatinib.

What key safety findings were reported in the results?

The study reported 382 pediatric cases and highlighted frequent system organ classes such as general disorders and gastrointestinal disorders. It also identified previously unreported AEs and observed off-label use in some regions.

Sep 30, 2026

Uploaded by Aran