Can intravenous iron therapy meet the unmet needs created by the new restrictions on erythropoietic stimulating agents?

Abstract

In 2008, after reports of an association between erythropoietic stimulating agent (ESA) therapy and the potential for either thrombotic cardiovascular events or more rapid tumor progression in some cancers, the Food and Drug Administration changed the product labeling for ESAs, adding a black box warning as well as more restrictive indications, especially in oncology patients. In addition the Centers for Medicare and Medicaid Services has placed significant restrictions on payments for ESA therapy. These new limitations on ESA have led to increased use of transfusions in anemic cancer patients. This increase in allogeneic transfusions potentially will place an additional burden on the US blood supply. Although allogeneic blood transfusion is one answer to ESA restrictions, the use of intravenous iron therapy (IV iron) is another possible alternative. We will discuss the use of IV iron as primary therapy for anemia, the use of combination IV iron and ESA therapy to improve efficiency and decrease costs, and evidence that IV iron with and without ESA therapy can reduce allogeneic blood transfusions in surgical patients. We will also review the available IV iron agents and their comparative safety profiles.