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Safety Labeling Changes on Anemia Drugs

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

The labeling changes incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007. The new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.

The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue, or well-being for patients with cancer or for patients with HIV undergoing zidovudine (AZT) therapy.

Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by AZT therapy in HIV patients.

For patients with cancer, the new boxed warnings emphasize that

• ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater.
• No clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.

The new warning also clarifies that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. It also states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

For patients with chronic kidney failure, the new boxed warning states that

• ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and serious cardiovascular reactions such as stroke, heart attack, or heart failure.

In addition to the boxed warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

For More Information
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html

Information on Erythropoiesis Stimulating Agents (ESA)
http://www.fda.gov/cder/drug/infopage/RHE/default.htm

Date Posted: November 8, 2007

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