Erythropoietin, the FDA, and Oncology

Abstract

As has been the case for patients with chronic renal failure, treatment with erythropoiesis-stimulating agents (ESAs) has substantially raised the hemoglobin concentrations of hundreds of thousands of patients with cancer, diminishing their need for red-cell transfusions during chemotherapy. At the same time, use of these agents has raised safety concerns because they can cause thromboembolic events and increase “the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL,” according to the black-box warning that the Food and Drug Administration (FDA) added to the prescribing information in March 2007.¹ Therefore, the . . .