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FDA Issues Alert for Erythropoiesis Stimulating Agents

February 20, 2007 -- FDA is issuing this alert to advise you of results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. By random assignment, patients received either Aranesp (darbepoetin alfa), an ESA, according to the dosing regimen in approved labeling or placebo. In this study, patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. ESAs are not FDA approved to treat anemia in cancer patients not receiving chemotherapy. The findings in this study of Aranesp may apply to other ESAs. See the Healthcare Professional Sheet below for more details.

Health care professional sheet in PDF or HTML.

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