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Title: Erythropoiesis Stimulating Agents (ESAs) - Results of Aranesp Study May Apply to Other ESAs

"Erythropoiesis Stimulating Agents (ESAs) - Results of Aranesp Study May Apply to Other ESAs"

BETHESDA, MD -- February 18, 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 complete MedWatch 2007 Safety summary, including links to the FDA Information For Healthcare Professionals Sheet and previous MedWatch alerts regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA SOURCE: Food and Drug Administration

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