FDA OK's new anemia drug safety plan
FDA OK's new anemia drug safety plan
WASHINGTON - The U.S. Food and Drug Administration says it has approved a risk management program for certain drugs used to treat anemia. The federal agency says the new program is designed to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis- Stimulating Agents. For patients with cancer, the program is also designed to help ensure the appropriate administration of the drugs, which they receive to treat anemia that can occur as a result of chemotherapy. ESAs -- including epoetin alfa, marketed as Procrit and Epogen, and darbepoetin alfa, marketed as Aranesp -- are forms of the human protein eryth- ropoietin, which stimulates bone marrow to make red blood cells, the FDA said. ESAs are approved for the treatment of anemia that may occur as a result of kidney failure, certain kinds of chemotherapy, the drug AZT and to treat anemia among certain patients undergoing surgery. Procrit, Epogen and Aranesp are manufactured Amgen Inc. of Thousand Oaks, Calif.
WASHINGTON - The U.S. Food and Drug Administration says it has approved a risk management program for certain drugs used to treat anemia. The federal agency says the new program is designed to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis- Stimulating Agents. For patients with cancer, the program is also designed to help ensure the appropriate administration of the drugs, which they receive to treat anemia that can occur as a result of chemotherapy. ESAs -- including epoetin alfa, marketed as Procrit and Epogen, and darbepoetin alfa, marketed as Aranesp -- are forms of the human protein eryth- ropoietin, which stimulates bone marrow to make red blood cells, the FDA said. ESAs are approved for the treatment of anemia that may occur as a result of kidney failure, certain kinds of chemotherapy, the drug AZT and to treat anemia among certain patients undergoing surgery. Procrit, Epogen and Aranesp are manufactured Amgen Inc. of Thousand Oaks, Calif.
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