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Exercising its new power to order drug companies to make label changes, the FDA is requiring manufacturers to revise prescribing information for two major erythropoiesis-stimulating agents (ESAs). The drugs, epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp), are approved to treat anemia in patients with renal failure and in patients with certain types of cancer being treated with chemotherapy. Epoetin alfa is also approved for several other indications.


The new labeling addresses concerns that the risks of ESA therapy may outweigh the benefits in some patients with cancer. Research shows that at certain dosages, ESAs cause tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid, and non-small-cell lung cancer. The labeling will emphasize that ESAs should be used for cancer patients only if their anemia is caused by chemotherapy, not another cause, and shouldn't be given to patients who are aiming for cure. In addition, ESAs should be used to maintain a hemoglobin level between 10 and 12 grams/dL, no higher. Research hasn't shown that higher levels are beneficial, and in patients with chronic renal failure, higher levels raise the risk of serious complications or death.


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