ArticleJapanese journal of clinical oncology2026
Safety profiles of dasatinib in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database.
Article in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveDasatinib 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.
methodsData 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.
resultsA total of 382 pediatric cases involving dasatinib were reported. The most frequent system organ classes included general disorders and 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.
conclusionThis 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.
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