Chemotherapy Drug Shortages in the United States: Genesis and Potential Solutions

In October 2011, the US Food and Drug Administration (FDA) announced the end of the cytarabine shortage. Cytarabine is the key chemotherapy drug for the management of leukemia in children and adults, particularly acute myeloid leukemia, and the announcement by the FDA of an end to this 11-month crisis was good news. However, in July 2011, we started experiencing shortages of daunorubicin, another drug critical to the management of leukemia and the second most important drug used to treat acute myeloid leukemia. The daunorubicin shortage has been mitigated somewhat by the fact that it can be replaced with other anthracylines, albeit with different toxicity profiles. However, daunorubicin is an essential component of clinical trial protocols for leukemia in the United States, and its shortage has created serious challenges in conducting leukemia research.