The U.S. Food and Drug Administration today approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs).
For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy.
ESAs, which include epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen Inc. ESAs are forms of the human protein erythropoietin, which stimulates bone marrow to make red blood cells.
In April 2008, FDA required Amgen Inc. to establish this risk management program based on studies that found that ESAs caused tumors to grow faster and resulted in earlier deaths in some cancer patients.
Amgen’s risk management program, referred to as a REMS or Risk Evaluation and Mitigation Strategy, requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to …
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