FDA Releases Q&A about ESA Medication Guides

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BETHESDA, Md.—The U.S. Food & Drug Administration (FDA) released answers to questions regarding the use of erythropoiesis-stimulating agents (ESAs) and their FDA-approved Medication Guides, which are now part of labeling for ESAs Aranesp, Epogen and Procrit.

The guides are designed to help patients make informed decisions about the risks and benefits of using ESAs and to give them a starting point for discussions with their doctors. The guide must be given to directly patients or their caregivers at the time an ESA is dispensed.

Erythropoiesis-stimulating agents trigger the bone marrow to produce more red blood cells when anemia is due to low red cell counts. For cancer patients, ESAs only are used during chemotherapy to reduce the need for blood transfusions. They are not appropriate for anemic cancer patients who not are having chemo, nor are they approved for chemotherapy patients whose treatment goal is cancer cure.

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