Bone Marrow Stimulant Drugs Get Black Box Warning Label

March 2007

Epoetin Alfa A new Food and Drug Administration (FDA) Public Health Advisory warns medical professionals and patients of the severe side effects of popular bone marrow stimulants. Drugs called erythropoiesis-stimulating agents (ESAs), known to consumers as Aranesp, Epogen, and Procrit, will receive black box warnings due to their potentially fatal risks.

The FDA study concluded that ESAs may increase the rate of:

Blood Clots
Heart Attacks
Heart Failure
Strokes
Tumor Growth
Death

ESAs are used to generate the natural ability of bone marrow to produce red blood cells. The drugs are approved to treat anemia in chronic kidney failure patients, cancer patients on chemotherapy, and HIV patients on AZT. ESAs are also approved to lower the number of blood transfusions needed for major surgery patients.

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Source: "Erythropoiesis-Stimulating Agents." FDA Public Health Advisory. March 9, 2007