New ESA Risk Management System
Tuesday, February 16, 2010
February 16, 2010 - The U.S. Food and Drug Administration (FDA) announced that it is creating a Risk Evaluation and Mitigation Strategy (REMS) for Erythropoiesis-Stimulating Agents (ESAs) (e.g., Procrit, Epogen, and Aranesp), which are used to treat anemia that can result from chemotherapy. Although the most significant requirements of the ESA REMS apply to healthcare providers who prescribe or dispense, but not those who only administer, ESAs to patients with cancer, there are implications for oncology nursing practice. Many of the details have yet to be released. Read a summary of the current information (New ESA Risk Management System), and check back for regular updates.