title: The new label for erythropoiesis stimulating agents: the FDA'S sentence.
abstract: On June 24, 2011, the U.S. Food and Drug Administration (FDA) revised the prescribing instructions (the label) for erythropoiesis-stimulating agents. The new label, the second revision since publication of the TREAT Study, placed new restrictions on the use of these agents, and increased the strength of warnings. We believe that the new label language may deprive patients of the full benefits of erythropoiesis-stimulating agent treatment and impair the opportunity to individualize treatment through shared decision making. Diminished discovery and innovation in the treatment of one of the most common and important complications of kidney disease may also be an unintended consequence of the label change.
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.forename: Kenar D
authors.initials: KD
authors.lastname: Jhaveri
mesh_terms: D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D011307:Drug Prescriptions / Q000592:standards*; D004920:Erythropoiesis / Q000187:drug effects*; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006397:Hematinics / Q000627:therapeutic use; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; C020622:hemoglobin B