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U.S. Department of Health and Human Services

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Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) November 2007

Audience: Oncologists, nephrologists, other healthcare professionals

[UPDATE 01/03/2008] FDA informed healthcare professionals of findings from two additional clinical studies, Preoperative Epirubicin Paclitaxel Aranesp Study (PREPARE), and the National Cancer Institute Gynecologic Oncology Group (COG-19), showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an Erythropoiesis-Stimulating Agent (ESA). Both the PREPARE study in breast cancer and the COG-19 study in cervical cancer showed higher rates of death and or tumor progression in patients who received an ESA compared to patients who did not receive an ESA. FDA strongly recommends that healthcare professionals discuss the risks of ESA-associated tumor progression and shortened survival in patients with cancer before starting or continuing ESA therapy.

[Posted 11/08/2007] FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure. For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater. For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk of death and other serious conditions. The new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

Additionally, the new boxed warnings clarify that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Further, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

[January 03, 2008 - Communication about an Ongoing Safety Review - FDA]
[November 08, 2007 - Labels for Epogen, Procit - FDA]
[November 08, 2007 - Label for Aranesp - FDA]
 

[November 08, 2007 - Drug Information Page - FDA]

Previous MedWatch Alerts:

[February 16, 2007]