Aranesp (Darbepoetin Alfa)

Aranesp (Darbepoetin Alfa)

Study Showing the Drug Ineffective in Reducing RBC Transfusions or Fatigue in Cancer Patients With Anemia and a Higher Mortality Rate Observed in the Aranesp Treatment Group

BETHESDA, MD -- January 29, 2007 -- 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.

Read the complete MedWatch 2007 Safety summary, including a link to the Dear Healthcare Professional letter, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Aranesp

SOURCE: U.S. Food and Drug Administration

Posted 5/07

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