It is characterized by low levels of circulating red blood cells, which are responsible for delivering oxygen to tissues throughout the body. Common symptoms of anemia are severe fatigue, shortness of breath, diminished activity levels, and a reduced overall feeling of well-being.

Severe anemia often requires treatment with blood transfusions, which have associated risks of infection, rejection, and increased medical costs. Furthermore, severe anemia may cause a delay in cancer treatment, resulting in less favorable chances of a cure or optimal long-term survival.

Use of medications to treat anemia caused by chemotherapy has been shown to have several benefits in cancer patients, including improved quality of life and decreased need for blood transfusions. Medications such as Procrit® (epoetin alfa) and Aranesp® (darbepoetin alfa) stimulate the body to produce more red blood cells, ultimately reducing anemia and its long-term effects. Controlled clinical trials have already demonstrated the ability of Aranesp to reduce the need for blood transfusions and improve quality of life among patients with various types of cancers whose anemia is caused by treatment with chemotherapy. Aranesp is currently approved by the FDA for the treatment of patients with non-hematologic (not originating from the blood) cancers who have anemia caused by treatment with chemotherapy.

Researchers recently conducted a multicenter clinical trial to evaluate the effectiveness of Aranesp among patients with cancer whose anemia was not caused by treatment with chemotherapy. One group of patients received Aranesp, while the other group received a placebo (inactive substitute); the groups were directly compared. Overall, treatment of these patients with Aranesp did not produce favorable results: red blood cell transfusions were not reduced among the group of patients treated with Aranesp compared to those who received placebo, and there were more deaths in the group of patients treated with Aranesp.

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These results indicate that Aranesp did not benefit cancer patients with anemia that wasn’t caused by treatment with chemotherapy. According to Amgen and the United States Food and Drug Administration (FDA), the agent Aranesp should be used for its approved indication in the prevention and treatment of anemia among cancer patients undergoing chemotherapy.

Reference: United States Food and Drug Administration. 2007 Safety Alert Aranesp® (darbepoetin alfa). Available at: http://www.fda.gov/medwatch/safety/2007/Aranesp_DHCP_012707.htm. Accessed January 2007.

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