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PLEASE BE AWARE OF THIS NOTICE ABOUT ARANESP AND PROCRIT


RandyW

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The FDA informed healthcare professionals of findings from two additional clinical studies, Preoperative Epirubicin Paclitaxel Aranesp Study, and the National Cancer Institute Gynecologic Oncology Group, 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.

On November 8th, the 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.

for more information: http://www.fda.gov/cder/drug/early_comm/ESA.htm

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I wonder if these tests focused solely on the people taking the shots vs. those not taking them, or if they even considered the fact that those needing the shots in the first place had consistently low blood counts and couldn't continue treatments= allowing their cancer to grow.

I would think that in and of itself would lead to a lower mortality before you even factor in the arenesp/procrit shots.

??? hmmmm I need to read this study again.

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