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Published on Mar 12, 2007 by Edgar Snyder

Bone Marrow Stimulant Drugs Get Black Box Warning Label

Bone Marrow Stimulant Drugs

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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Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Ohio and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

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