The new label for erythropoiesis stimulating agents: the FDA'S sentence

Semin Dial. 2012 May;25(3):263-6. doi: 10.1111/j.1525-139X.2012.01065.x. Epub 2012 Apr 20.

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.

Publication types

  • Case Reports
  • Editorial

MeSH terms

  • Anemia / blood
  • Anemia / drug therapy*
  • Anemia / etiology
  • Darbepoetin alfa
  • Drug Prescriptions / standards*
  • Erythropoiesis / drug effects*
  • Erythropoietin / analogs & derivatives*
  • Erythropoietin / therapeutic use
  • Hematinics / therapeutic use
  • Hemoglobins / metabolism*
  • Humans
  • Kidney Failure, Chronic / blood
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / therapy*
  • Male
  • Middle Aged
  • Renal Dialysis*
  • United States
  • United States Food and Drug Administration

Substances

  • Hematinics
  • Hemoglobins
  • Erythropoietin
  • Darbepoetin alfa
  • hemoglobin B