FDA: Procrit, Aranesp & Epogen Raise Risk for Serious Complications

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

Audience:

Indication:

[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.

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