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FDA Urges Reduced Doses for Anemia Drugs
Date:6/25/2011

By Steven Reinberg
HealthDay Reporter

FRIDAY, June 24 (HealthDay News) -- Doctors should use the anemia drugs Procrit, Epogen and Aranesp more cautiously in patients with chronic kidney disease, U.S. health officials said Friday.

The new warning comes in response to data showing that patients on these drugs face a higher risk of cardiovascular problems such as heart attack, heart failure, stroke, blood clots and death, the U.S. Food and Drug Administration said.

"FDA is recommending new, more conservative dosing recommendations for erythropoiesis-stimulating agents [ESAs] for patients with chronic kidney disease," Dr. Robert C. Kane, acting deputy director for safety in the division of hematology products, said during a news conference Friday.

These recommendations are being added to the drug label's black box warning and sections of the package inserts, he said.

This is not the first time health risks have been linked to these anemia drugs. They have also been tied to increased tumor growth in cancer patients and may cause some patients to die sooner. Also, cancer patients have an increased risk of blood clots, heart attack, heart failure and stroke, according to the FDA.

Procrit, Epogen and Aranesp are synthetic versions of a human protein known as erythropoietin that prods bone marrow to produce red blood cells. The drugs are typically used to treat anemia in cancer patients and to reduce the need for frequent blood transfusions. Anemia also occurs in patients with chronic kidney disease. Anemia results from the body's inability to produce enough red blood cells, which contain the hemoglobin needed to carry oxygen to the cells.

Currently, labels on these drugs say ESAs should be used to achieve and maintain hemoglobin levels within 10 to 12 grams per deciliter of blood in patients with chronic kidney disease. These target levels will no longer be given on the label, the agency added.


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