The New Label for Erythropoiesis Stimulating Agents: The FDA’S Sentence
Article first published online: 20 APR 2012
© 2012 Wiley Periodicals, Inc.
Seminars in Dialysis
Volume 25, Issue 3, pages 263–266, May/June 2012
How to Cite
Fishbane, S. and Jhaveri, K. D. (2012), The New Label for Erythropoiesis Stimulating Agents: The FDA’S Sentence. Seminars in Dialysis, 25: 263–266. doi: 10.1111/j.1525-139X.2012.01065.x
- Issue published online: 20 MAY 2012
- Article first published online: 20 APR 2012
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.