Labeling Changes Stronger Warnings Approved For Erythropoietic Agents

The FDA has approved revised boxed warnings and safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. ESAs are a bio-engineered version of a protein made in the kidneys that stimulates bone marrow to produce more red blood cells.

A sampling of the new statements addresses the following:

•Aranesp, Epogen, and Procrit pose certain risks to patients with cancer and with chronic kidney failure.

•Symptoms of anemia, fatigue, and quality of life have not been shown to improve in cancer patients receiving ESAs.

•ESAs caused tumor growth and shortened survival in some cancer patients when they received doses intended to achieve a hemoglobin level of 12 g/dL or greater. (It is unclear whether the risk is similar with doses given to achieve a hemoglobin level below 12 g/dL.)

•ESAs should be used only in patients with cancer to treat chemotherapy-induced anemia, and they should be discontinued after chemotherapy is completed.

•For patients with chronic kidney failure, ESAs should be used to maintain hemoglobin levels between 10 and 12 g/dL.

•No data have shown that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.

The new labeling also provides instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in hemoglobin.

Kidney disease raises the risk of early death, heart attack, stroke, and hypertension; unfortunately, according to the NIH, a growing number of Americans have chronic kidney disease, but most remain unaware of it. This unawareness hampers efforts to to prevent kidney failor more information on ESAs and chronic kidney disease, see the article on page 661.

(Sources: FDA, November 8, 2007