The new FDA label for erythropoietin treatment: how does it affect hemoglobin target?
The erythropoietin analogs have been an important advance for the treatment of the anemia of kidney disease, resulting in reduced need for blood transfusion and improved quality of life. Recent studies, however, have indicated risks associated with targeting higher levels of hemoglobin (Hb). As a result, in March 2007, the US Food and Drug Administration (FDA) substantially changed prescribing information for these drugs to alert clinicians to these risks. In this review, we consider the recent literature, the change in FDA warnings, and new National Kidney Foundation Anemia Guidelines. Suggestions for new Hb targets during erythropoiesis-stimulating agent treatment are presented.
Fishbane
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Division of Nephrology, Winthrop-University Hospital, Mineola, New York 11501, USA. sfishbane@metrorenal.com
Nissenson
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D000740:Anemia / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D004348:Drug Labeling; D004921:Erythropoietin / Q000009:adverse effects* / Q000031:analogs & derivatives; D005582:Foundations; D006454:Hemoglobins / Q000187:drug effects / Q000378:metabolism*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000401:mortality; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration
D006454:Hemoglobins; D004921:Erythropoietin