On November 16, 2006, the Food and Drug Administration (FDA) issued a public health advisory over certain drugs being used to treat anemia, including Procrit, Epogen, and Aranesp. The FDA did not issue a recall for Procrit but did heed warnings from a research study published November 16, 2006 in the New England Journal of Medicine. The study found patients treated with Procrit whose hemoglobin levels were raised above the level recommended on the label had a higher chance of heart attack, heart failure, stroke, or even death.

Anemia, or having a low red blood cell count, is a condition commonly experienced by patients with kidney failure and is often treated by Procrit, Epogen or similar drugs to stimulate bone marrow into producing red blood cells. These drugs are also frequently prescribed for cancer patients undergoing chemotherapy.

In addition to the concerns raised by the study in the New England Journal of Medicine, an article in the November 17, 2006 online edition of the British medical journal The Lancet reported about half of all kidney dialysis patients have their red blood cell counts boosted beyond what the FDA says is safe, and about 20 percent experience red blood cell counts in the potential danger zone. This creates a risk for life-threatening conditions such as heart attack and stroke, which could lead to death.

"There is a disconnect between the prescribing information for these drugs and their use in maintaining high hemoglobin values," said Dr. Robert Steinbrook of Dartmouth Medical School, who authored the Lancet article. "It raises patient safety and public health concerns."

In their advisory, the FDA said that any patients having taken Procrit, Epogen, Aranesp or similar medicines should contact their doctor if they experience:

• Shortness of breath
• Pain in the legs
• Swelling in the legs
• Increase in blood pressure

The FDA alert also raises questions about new clinical prescribing guidelines issued by the National Kidney Foundation that suggest it is desirable to boost red blood cell counts higher than what the FDA recommends. The prescribing guidelines were underwritten by pharmaceutical companies.

Medicare pays for most dialysis treatments in the United States at a cost of about $2 billion annually. Certain Medicare reimbursement policies have also come under fire for guaranteeing dialysis clinics a 6 percent profit margin for distributions of Epogen, which may be encouraging clinics to give patients more of the potentially dangerous drug.

Sources: Christopher Rowland, "FDA warns on anemia-drug dosing," Boston Globe. November 18, 2006. Accessed November 20, 2006; FDA Public Health Advisory: Procrit, Epogen, Aranesp, November 16, 2006, accessed November 20, 2006.