Higher Mortality when Treating Certain Anemias with Erythrop

Amgen has notified healthcare professionals that the erythropoietic agent Aranesp (darbepoetin alfa) is not effective in treating cancer patients whose anemia is not associated with the use of chemotherapy. This treatment can also increase mortality in these patients. FDA is cautioning healthcare professionals that these findings also apply to similar products such as Procrit (epoetin alfa)and Epogen (epoetin alfa).

Amgen was studying how well the drug could treat anemia in patients with active malignant disease who were not receiving chemotherapy or radiation therapy as compared with similar patients given a placebo. The study showed that the drug did not reduce RBC transfusions in the patients treated with Aranesp. It also showed a higher mortality rate in patients treated with the drug.

Procrit, Aranesp and Epogen are all approved for treating anemia associated with cancer chemotherapy. They are not approved to treat anemia in patients who are not receiving chemotherapy. FDA warns that using these drugs to treat anemic cancer patients who are not currently on chemotherapy may offer no benefit and could cause serious harm.

Additional Information:

FDA MedWatch Safety Alert. Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa). March 9, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA

FDA MedWatch Safety Alert. Aranesp (darbepoetin alfa). January 27, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Aranesp

Category:

News & Politics

Tags:

• Anemia
• Erythropoietic
• Agents
• Mortality
• FDA
• Cancer
• Patients
• Aranesp
• Procrit
• Epogen
• Chemotherapy

[rockygreenmountains]

what about anemia due to kidney failure