1. Aschenbrenner, Diane S. MS, APRN-BC


* The FDA has mandated the creation of a risk evaluation and mitigation strategy for the ESAs marketed as Epogen, Procrit, and Aranesp.


* These ESAs increase the risk of tumor growth or recurrence and even death in some patients.


* ESAs can also increase patients' risks of serious cardiovascular events, stroke, and blood clots.



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Erythropoiesis-stimulating agents (ESAs), such as epoetin alfa (Epogen and Procrit) and darbepoetin alfa (Aranesp), are used to stimulate the production of red blood cells. The labels of these drugs already carry black box warnings that they increase the risk of tumor growth and shorten survival in patients with cancer. The black box warnings also state that when used in patients with chronic renal failure, ESAs can increase the risk of heart attack, heart failure, and stroke when "administered . . . to target hemoglobin levels of 13 g/dL and above." In patients undergoing surgery, they can lead to deep venous thrombosis if they're given without the concurrent use of anticoagulants.


The Food and Drug Administration is now requiring the creation of a risk evaluation and mitigation strategy (REMS) for ESAs, a safety plan that will include a medication guide for patients and specialized training and education for hospitals and health care providers who prescribe or dispense ESAs to patients with cancer. Providers will also be required to provide documentation that they have discussed the ESA-related risks with patients. No special training will be required if the drugs are given to patients without cancer, but all patients will receive the medication guide.


Nurses should teach patients about the possible adverse effects and emphasize that the medication guide should be read with each prescription. Nurses should also closely monitor patients receiving ESAs for adverse effects. For more information, go to