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Dasatinib-Associated Chylothorax: A Scoping Review and Pharmacovigilance Analysis
Eleonora Castellana1, Patricia Madalina Budau2,3,4, Cecilia Miglietta1,5
1Hospital Pharmacy, University Hospital Città della Salute e della Scienza of Turin, Turin, Piedmont, Italy.
Therapeutic Innovation & Regulatory Science
|May 11, 2026
Summary
Dasatinib-associated chylothorax is a rare but significant adverse event in leukemia patients. Early recognition and monitoring are crucial for effective management and improved patient outcomes.
Area of Science:
- Oncology
- Pharmacovigilance
- Hematology
Background:
- Dasatinib is a tyrosine kinase inhibitor used for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
- Rare instances of chylothorax have been reported in patients receiving dasatinib therapy.
Purpose of the Study:
- To systematically review case reports and pharmacovigilance data on dasatinib-associated chylothorax.
- To characterize the clinical presentation, management strategies, and patient outcomes.
Main Methods:
- A scoping review adhering to PRISMA 2020 guidelines was performed.
- Searched PubMed/MEDLINE and an institutional platform for case reports up to February 2026.
- Analyzed FDA Adverse Event Reporting System (FAERS) data through September 2024 for hypothesis generation.
Main Results:
- 42 publications detailed 44 patients with dasatinib-associated chylothorax, aged 5-90 years.
- Chylothorax onset ranged from 2 months to 10 years after dasatinib initiation.
- Drug discontinuation and thoracentesis were common management strategies, often leading to resolution. FAERS identified 104 serious adverse event reports, with severe outcomes being uncommon.
Conclusions:
- Dasatinib-associated chylothorax is an uncommon but clinically relevant event, even with prolonged therapy.
- Long-term patient monitoring and prompt diagnosis are essential.
- Pharmacovigilance findings are hypothesis-generating; further studies are needed to confirm the association.
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