ArticleTherapeutic innovation & regulatory science2026
Dasatinib-Associated Chylothorax: A Scoping Review and Pharmacovigilance Analysis.
Article in Therapeutic innovation & regulatory science, 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
backgroundDasatinib, a second-generation tyrosine kinase inhibitor widely used for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), has been reported in association with rare cases of chylothorax.
objectiveTo systematically summarize published case reports and complement these findings with pharmacovigilance data in order to characterize the clinical presentation, management, and outcomes of dasatinib-associated chylothorax.
methodsA scoping review was conducted in accordance with PRISMA 2020 recommendations. PubMed/MEDLINE and an institutional discovery platform were searched for case reports and case series published up to February 13, 2026. Eligible reports included patients developing chylothorax during dasatinib therapy. In parallel, data from the FDA Adverse Event Reporting System (FAERS) were analyzed through September 30, 2024. Descriptive analyses were performed. FAERS data were interpreted as hypothesis-generating only.
resultsForty-two publications describing 44 patients met the inclusion criteria. Patients ranged from 5 to 90 years of age, with a slight male predominance. Time from dasatinib initiation to chylothorax onset varied from 2 months to 10 years. Management most commonly involved drug discontinuation and thoracentesis, frequently followed by clinical resolution. FAERS analysis identified 104 unique reports of chylothorax associated with dasatinib, all classified as serious adverse events; severe outcomes were uncommon. Reporting trends increased over time, particularly between 2017 and 2023. LIMITATIONS: Evidence derives from case reports and spontaneous reporting data, which do not allow estimation of incidence or causal inference and are subject to reporting bias and incomplete information.
conclusionsDasatinib-associated chylothorax is an uncommon but clinically relevant event that may occur even after prolonged therapy. Long-term monitoring and prompt recognition are essential. Findings from pharmacovigilance data should be interpreted cautiously and considered hypothesis-generating. Further studies using large retrospective administrative databases are warranted to formally evaluate this potential association.
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