Use of other EPO agents may also increase risk

February 26, 2007

Findings from a clinical trial showing that darbepoetin alfa (Aranesp, Amgen) is not effective in reducing the need for transfusions may also pertain to other erythropoiesis-stimulating agents (ESAs), according to the FDA. The darbepoetin study showed a higher death rate and no decrease in the frequency of necessary transfusions compared with placebo. The FDA says it will review and analyze the complete study results following submission by Amgen, however it has already been determined that the Aranesp did not reduce the need for transfusions and showed a higher death rate. In the meantime, the FDA reminds healthcare professionals to strictly adhere to prescribing guidelines and that treating cancer patients not currently on chemotherapy with an ESA may offer no benefit and could cause serious harm

Findings from a clinical trial showing that darbepoetin alfa (Aranesp, Amgen) is not effective in reducing the need for transfusions may also pertain to other erythropoiesis-stimulating agents (ESAs), according to the FDA. The darbepoetin study showed a higher death rate and no decrease in the frequency of necessary transfusions compared with placebo. The FDA says it will review and analyze the complete study results following submission by Amgen, however it has already been determined that the Aranesp did not reduce the need for transfusions and showed a higher death rate. In the meantime, the FDA reminds healthcare professionals to strictly adhere to prescribing guidelines and that treating cancer patients not currently on chemotherapy with an ESA may offer no benefit and could cause serious harm

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