The Erythropoietic Receptors Agonists: FDA Warnings,Changing Guidelines,and Other Responses to Negative Data

In 2006, two large, international, randomized trials comparing high-intensity to low-intensity treatment with epoetin alfa were published. Both trials demonstrated that low-intensity treatment—with goal serum hemoglobin values of 11.3 or 10.5 to 11.5 g/dL, respectively—was associated with improved outcomes in patients with anemia and nondialysis-dependent chronic kidney disease. Over the following 6 to 12 months, regulatory agencies, insurers, and hospital systems would react, sometimes dramatically, as further literature became available that caused a rethinking of the appropriate use of these valuable agents. This article will summarize the response to recent literature regarding the administration of erythropoietic stimulating agents.