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

Manny Saltiel, PharmD, FASHP, FCCP

Comprehensive Pharmacy Services, Costa Mesa, California, msaltiel{at}CPSpharm.net

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.

Key Words: Erythropoietic stimulating agonists • chronic kidney disease • anemia • regulatory controls

This version was published on December 1, 2008

Journal of Pharmacy Practice, Vol. 21, No. 6, 402-404 (2008)
DOI: 10.1177/0897190008318913


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