On November 8th, the Food and Drug Administration (FDA) announced labeling changes for erythropoiesis-stimulating agents (ESAs) addressing the potential risk that the drugs Aranesp and Procrit/Epogen pose to patients with cancer and patients with chronic kidney failure.  National Patient Advocate Foundation participated in the FDA briefing and due to the complexity of the issue, feels patients will benefit by having all FDA materials available to them so that they may discuss treatment issues with their physicians.

The new label allows patients and providers to determine collaboratively when ESAs should be used.  FDA further identified that these products are used as supportive care. Richard Pazdur, M.D., Director of the Office of Oncology Drug Products at FDA, encouraged patients to ask their doctors the following questions if ESAs are part of their treatment:

• What is the intent of the use of this drug in my treatment?
• Is it curative?
• Is it palliative?

Currently, the FDA is developing a Medication Guide (written in patient-friendly language) to better inform patients about the risks and benefits associated with ESA use including additional questions to ask your doctor.  Since this guide is not yet available, NPAF urges patients to contact their physicians if they have additional questions.

For more information visit www.fda.gov or contact the Cancer Liasion Program within the FDA's Office of Special Health Issues at 301-827-4460.

Additional Information

NPAF Press Release

FDA Public Health Advisory

Questions & Answers

Aranesp Label

Procrit/Epogen Label