| The New Label for Erythropoiesis Stimulating Agents: The FDA'S Sentence. | |
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MedLine Citation:
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PMID: 22515844 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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Steven Fishbane; Kenar D Jhaveri |
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Publication Detail:
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Type: EDITORIAL Date: 2012-4-20 |
Journal Detail:
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Title: Seminars in dialysis Volume: - ISSN: 1525-139X ISO Abbreviation: - Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-4-20 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8911629 Medline TA: Semin Dial Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2012 Wiley Periodicals, Inc. |
Affiliation:
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Department of Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, New York. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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