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Anemia Drugs Change Black Box Warning

FDA Approves Revision to Warning Label for Procrit, Aranesp, and Epogen Anemia Drugs

ESAs and Cancer continued...

Health care providers determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient's red blood cells.

An earlier boxed warning, approved in March, described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients.

Today's new boxed 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.

Moreover, the revised warning states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

ESAs and Chronic Kidney Failure

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 and 12 g/dL.

Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk of death and serious cardiovascular reactions such as stroke, heart attack, or heart failure, according to the FDA.

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

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 patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.

Procrit, Aranesp, and Epogen are made by Amgen. Procrit is sold by Ortho Biotech, a subsidiary of Johnson & Johnson.

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