Does CYTARABINE\FLUDARABINE\GRANULOCYTE COLONY-STIMULATING FACTOR NOS\IDARUBICIN Cause Off label use? 6 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 6 reports of Off label use have been filed in association with CYTARABINE\FLUDARABINE\GRANULOCYTE COLONY-STIMULATING FACTOR NOS\IDARUBICIN. This represents 26.1% of all adverse event reports for CYTARABINE\FLUDARABINE\GRANULOCYTE COLONY-STIMULATING FACTOR NOS\IDARUBICIN.
How Dangerous Is Off label use From CYTARABINE\FLUDARABINE\GRANULOCYTE COLONY-STIMULATING FACTOR NOS\IDARUBICIN?
Of the 6 reports, 4 (66.7%) resulted in death, 1 (16.7%) required hospitalization.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for CYTARABINE\FLUDARABINE\GRANULOCYTE COLONY-STIMULATING FACTOR NOS\IDARUBICIN. However, 6 reports have been filed with the FAERS database.