Neutropenia and infectious events during off-label treatment with venetoclax in children with malignant disease: a pharmacovigilance analysis of FDA adverse event reporting system reports
Pharmacovigilance data highlight serious infection risks with a cancer drug in children, helping doctors prescribe and monitor more safely.
This FAERS pharmacovigilance analysis identified and quantified disproportionality signals for neutropenia and infectious adverse events in pediatric cancer patients receiving off-label venetoclax, a BCL-2 inhibitor increasingly used in pediatric AML/ALL. These findings have direct safety implications for pediatric oncology prescribing and monitoring protocols in a population with high unmet need.
What the study was
- Study design
- Pharmacovigilance FAERS database analysis
- Population
- Pediatric patients with hematologic malignancies receiving off-label venetoclax; FAERS reporting system
- Category
- Drug Development
- Maturity
- Exploratory
- Journal
- Annals of Hematology
Why it surfaced
Safety signal characterization for venetoclax in pediatric hematologic malignancies (high unmet need, underserved population); FAERS disproportionality approach is standard method.
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