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The FDA has discontinued the Risk Evaluation Mitigation Strategy (REMS) program for the erythropoiesis-stimulating agents (ESAs). The program, known as the ESA Apprise Oncology Program, was implemented in 2011 to help ensure the benefit of using the ESAs outweighed the risks in patients with anemia due to myelosuppressive chemotherapy. Analysis of randomized clinical trials data showed a risk of decreased overall survival and a risk of increased tumor progression or disease recurrence when ESAs are used in these patients. Other risks with ESA therapy, not unique to the oncology population include death, myocardial infarction, stroke, thrombosis of vascular access, and venous thromboembolism.
The FDA reviewed the REMS Assessments submitted by Amgen and conducted additional analyses to monitor the REMS program. Their analysis indicated that prescribers demonstrate satisfactory knowledge of the risks of ESAs in cancer patients and the need to counsel patients on these risks; and, prescribers are appropriately prescribing the ESAs in accordance with the intended use as an alternative to red blood cell transfusion for anemia secondary to myelosuppressive chemotherapy. Additionally, labeling changes in the products and coverage limitations imposed by the Center for Medicare and Medicaid Services (CMS) led to fewer chemotherapy patients receiving ESAs, a larger proportion of the patients receiving ESAs initiating therapy once their hemoglobin was less than 10 g/dL, and a larger proportion of the patients receiving ESAs initiating therapy at the dosage recommended in the prescribing information. Based on the above analysis and changes in drug utilization, FDA concluded the REMS program is no longer necessary. The risk of decreased overall survival and increased tumor progression or disease recurrence still exists in cancer patients, but the prescribing information adequately communicates these risks. Continue discussing the risks and benefits of ESAs with patients before initiating therapy.
Additional information is available from the following links:
- FDA Drug Safety Information – April 13, 2017:
www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109375.htm