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, AranespFDA issues public health advisory on risks to Procrit/Epogen & Aranesp
Healthcare Professionals
FDA Sends Procrit/Epotin & Aranesp Warning to Healthcare ProfessionalsFDA Warns healthcare professionals of risk to Procrit/Epotin & Aranesp
Sodium Chromate
Covidien annnounces recall of lot of Sodium Chromate Cr-51Lot of Sodium Chromate Cr-51 recalled by Covidien; may be subpotent
