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FDA drops prescriber training for ESAs in chemo patients

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Clinicians have a better handle on prescribing erythropoiesis-stimulating agents (ESAs) appropriately for chemotherapy-related anemia and no longer need special training to prescribe them, FDA announced. The ESAs in question are epoetin alfa (Epogen and Procrit—Amgen) and darbepoetin alfa (Aranesp—Amgen).

Clinicians have a better handle on prescribing erythropoiesis-stimulating agents (ESAs) appropriately for chemotherapy-related anemia and no longer need special training to prescribe them, FDA announced. The ESAs in question are epoetin alfa (Epogen and Procrit—Amgen) and darbepoetin alfa (Aranesp—Amgen). Warnings on the labels of these ESAs note that the agents increased the risk for tumor progression or recurrence in patients with cancer and shortened their survival in clinical trials. With these issues in mind, FDA ordered a risk evaluation and mitigation strategy (REMS) in 2010, which required clinicians to receive extra training on administering the drugs and counseling patients about their risks, benefits, and permitted uses. However, FDA said on April 13 that the REMS was no longer needed to ensure that the benefits of ESAs outweigh their risks. FDA based this decision on an Amgen study of the REMS as well as its own analysis of how various regulatory actions have affected the use of ESAs. Amgen's study found that prescribers demonstrated "acceptable knowledge" about the risks of ESAs and the need to communicate them to patients.

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http://www.medscape.com/viewarticle/878611

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