WEDNESDAY, Feb. 17 (HealthDay News) -- Under a new safety plan approved Feb. 16 by the U.S. Food and Drug Administration, physicians will be required to provide all patients prescribed Erythropoiesis-Stimulating Agents (ESAs) with a Medication Guide, and to receive specific training and certification for the proper use of these agents in cancer patients receiving chemotherapy.
After studies showed that ESAs may speed tumor growth and contribute to premature mortality in some cancer patients, the FDA ordered Amgen -- manufacturer of the ESAs epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) -- to develop a risk management program. The company responded with a REMS (Risk Evaluation and Mitigation Strategy), which includes a subcomponent called APPRISE (Assisting Providers and Cancer Patients With Risk Information for the Safe Use of ESAs).
Under the risk management program, Amgen is required to ensure that cancer specialists register and maintain active enrollment in APPRISE, complete a training module on how to use ESAs in cancer patients, discuss the risks and benefits of ESAs with cancer patients prior to initiating a course of treatment, and document the discussions with a written acknowledgement from each patient.
"Evaluation of ESAs has been an ongoing and intensive process since 2004, involving a series of public meetings, labeling changes, and a required Medication Guide," Richard Pazdur, M.D., director of the Office of Oncology Products in the FDA's Center for Drug Evaluation and Research in Silver spring, Md., said in a statement. "This new risk management program will help ensure that patients and their health care professionals have fully considered the benefits and risks of using ESAs."
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