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.

FDA ALERT [11/16/2006]: A clinical study published November 16, 2006 in the New England Journal of Medicine found that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL have a significantly higher chance for serious and life threatening cardiovascular complications, as compared to those treated with an ESA to a target hemoglobin concentration of 11.3 g/dL. In this study (titled “Correction of Hemoglobin and Outcomes in Renal Insufficiency” (CHOIR)), life threatening cardiovascular complications were a composite endpoint of death, myocardial infarction, hospitalization for congestive heart failure, and stroke. The CHOIR study findings underscore the importance of following the currently approved prescribing information for Procrit, Epogen, and Aranesp, including the dosing recommendation that the target hemoglobin not exceed 12 g/dL. See the Healthcare Professional Sheet at: http://www.fda.gov/cder/drug/InfoSheets/HCP/RHE_HCP.htm

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.