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Procrit/Aranesp/Epogen

in this section: FDA Advisory | Healthcare Professionals | FDA Warning, Erythropoietin


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FDA ALERT: Procrit, Aranesp and Epogen Increase Risk for Serious Cardiovascular Complications



Audience: Oncologists, nephrologists, and other healthcare professionals
Indication: Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.

[Posted 11/17/2006] 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.


see also:

FDA Advisory FDA Public Health Advisory for Procrit, Epogen, Aranesp
FDA issues public health advisory on risks to Procrit/Epogen & Aranesp

Healthcare Professionals FDA Sends Procrit/Epotin & Aranesp Warning to Healthcare Professionals
FDA Warns healthcare professionals of risk to Procrit/Epotin & Aranesp

Sodium Chromate Covidien annnounces recall of lot of Sodium Chromate Cr-51
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