Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals of a newly published clinical
study showing that patients treated with an erythropoiesis-stimulating
agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL
are at a significantly increased risk for serious and life threatening
cardiovascular complications, as compared to use of the ESA to target a
hemoglobin concentration of 11.3 g/dL. The "Correction of Hemoglobin and
Outcomes in Renal Insufficiency" study, published November 16, 2006 in
the New England Journal of Medicine, reports the adverse cardiovascular
complications as a composite of the occurrence of one of the following
events: death, myocardial infarction, hospitalization for congestive
heart failure, or stroke.
The study findings underscore the importance of following the currently
approved prescribing information for Procrit, Epogen, and Aranesp,
including the dosing recommendation that the target hemoglobin not
exceed 12 g/dL.
Read the complete MedWatch 2006 Safety summary, including links to the
FDA Public Health Advisory and FDA Information for Healthcare
Professionals regarding this issue at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#erythropoiesis
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FDA notified healthcare professionals of a newly published clinical
study showing that patients treated with an erythropoiesis-stimulating
agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL
are at a significantly increased risk for serious and life threatening
cardiovascular complications, as compared to use of the ESA to target a
hemoglobin concentration of 11.3 g/dL. The "Correction of Hemoglobin and
Outcomes in Renal Insufficiency" study, published November 16, 2006 in
the New England Journal of Medicine, reports the adverse cardiovascular
complications as a composite of the occurrence of one of the following
events: death, myocardial infarction, hospitalization for congestive
heart failure, or stroke.
The study findings underscore the importance of following the currently
approved prescribing information for Procrit, Epogen, and Aranesp,
including the dosing recommendation that the target hemoglobin not
exceed 12 g/dL.
Read the complete MedWatch 2006 Safety summary, including links to the
FDA Public Health Advisory and FDA Information for Healthcare
Professionals regarding this issue at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#erythropoiesis
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