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Warning Date
    2007-04-28

Aranesp ® is ineffective for non- chemotherapy induced anemia.

2007-04-28

Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp ® (Darbepoetin alfa) was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy.

The study also showed higher mortality in patients receiving Aranesp. Aranesp is approved for the treatment of patients with anemia caused by the chemotherapy treatment of the malignant disease and should only be used in accordance with its approved product labeling.

Source: U.S. Food and Drug Administration

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