FDA Warns About Erythropoiesis Stimulating Agents (ESAs) - Results of Aranesp Study May Apply to Other ESAs

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ROCKVILLE, Md., Feb. 16, 2007--FDA notified healthcare professionals of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other ESAs. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.

Read the MedWatch alert below.  More information is attached.

FDA ALERT [2/16/2007]: 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.


Call 1-800-FDA-1088 (1-800-332-1088)

Posted: February 2007


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