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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 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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