Document Detail

The new label for erythropoiesis stimulating agents: the FDA'S sentence.
MedLine Citation:
PMID:  22515844     Owner:  NLM     Status:  MEDLINE    
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.
Steven Fishbane; Kenar D Jhaveri
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Publication Detail:
Type:  Case Reports; Editorial     Date:  2012-04-20
Journal Detail:
Title:  Seminars in dialysis     Volume:  25     ISSN:  1525-139X     ISO Abbreviation:  Semin Dial     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-05-21     Completed Date:  2012-11-27     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  8911629     Medline TA:  Semin Dial     Country:  United States    
Other Details:
Languages:  eng     Pagination:  263-6     Citation Subset:  IM    
Copyright Information:
© 2012 Wiley Periodicals, Inc.
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MeSH Terms
Anemia / blood,  drug therapy*,  etiology
Drug Prescriptions / standards*
Erythropoiesis / drug effects*
Erythropoietin / analogs & derivatives*,  therapeutic use
Hematinics / therapeutic use
Hemoglobins / metabolism*
Kidney Failure, Chronic / blood,  complications,  therapy*
Middle Aged
Renal Dialysis*
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Hematinics; 0/Hemoglobins; 11096-26-7/Erythropoietin; 15UQ94PT4P/darbepoetin alfa; 9041-75-2/hemoglobin B

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