February 16, 2010
FDA announces safety plan for erythropoiesis-stimulating agentsThe FDA has approved a risk management program to inform healthcare providers and patients about the risks of erythropoiesis-stimulating agents (ESAs). ESAs include epoetin alfa (Procrit, from Centocor Ortho Biotech and Epogen, from Amgen) and darbepoetin alfa (Aranesp, from Amgen). Amgen's APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program, which is part of the Risk Evaluation and Mitigation Strategy (REMS), requires specific training and certification of healthcare professionals who administer chemotherapy to patients with cancer and counseling of their patients. It does not apply to patients being treated with an ESA for anemia due to other circumstances.
The FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.
Through the risk management program, Amgen must ensure that healthcare professionals who treat patients with cancer do the following:
- Register and maintain active enrollment in the ESA APPRISE program
- Complete a special training module on how to use ESAs in patients with cancer
- Discuss the risks, benefits, and FDA-approved uses of ESAs with patients who have cancer before beginning a course of ESA treatment and document this discussion with a written acknowledgement from the patient
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200391.htm.