FDA Alert for Darbepoetin alfa

Darbepoetin

The FDA has issued an alert about the use of darbepoetin alfa (Aranesp), an ery-thropoiesis-stimulating agent (ESA), to treat anemia in cancer patients who are not receiving chemotherapy. In a large clinical trial, patients randomly received either the approved dosing regimen of darbepoetin alfa or placebo. The treated patients had a higher death rate and no reduction in the need for transfusions, compared with placebo patients.
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ESAs are not approved by the FDA to treat anemia in cancer patients not receiving chemotherapy.