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
Related Documents :
12514314 - Participation, power and beliefs shape local food and nutrition policy.
23603224 - Pre-meal affective state and laboratory test meal intake in adolescent girls with loss ...
8738874 - Policy considerations for a realistic approach to hunger in nigeria.
18755214 - Marketing of foods of minimal nutritional value to children in schools.
24598424 - Increased predation of nutrient-enriched aposematic prey.
1117374 - Fine structure of possible photoreceptor in cercariae of schistosoma mansoni.
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.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
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

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  A review of Platelet Derived Growth Factor playing pivotal role in bone regeneration.
Next Document:  Splicing Modulation Mediated by Small Nuclear RNAs as Therapeutic Approaches for Muscular Dystrophie...