Safety Plan Requirement for Erythropoiesis-Stimulating Agents

2/18/2010
The FDA and Amgen are notifying health care providers and patients that all erythropoiesis-stimulating agents (ESAs), including Procrit, Epogen, and Aranesp, must be prescribed and used under a risk evaluation and mitigation strategy (REMS) to ensure safe use. Studies show that ESAs can increase the risk of tumor growth and shorten survival rates in cancer patients, in addition to increasing the risk of heart attack and heart failure, stroke, or blood clots. As part of the REMS, a Medication Guide must be provided to all patients explaining the risks and benefits associated with ESA use. The FDA has also required Amgen to develop the ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program to train health care professionals in the prescribing and dispensing of ESAs. Only those who complete the training will be allowed to prescribe and dispense ESAs. ESAs are approved for the treatment of anemia that may occur due to kidney failure, certain kinds of chemotherapy, and zidovudine administration and anemia occurring in certain patients undergoing surgery.
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