Black Box Warning Ordered for Aranesp, Epogen, and Procrit
 

Black Box Warning Ordered for Aranesp, Epogen, and Procrit

http://www.procrit.com/HCP07.pdf

A New Boxed Warning providing the following information:
• Avoid serious cardiovascular and arterial and venous thromboembolic events by using the lowest dose of [Aranesp /EPOGEN/PROCRIT] that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion
• [Aranesp /EPOGEN/PROCRIT] and other ESAs increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL
• Use of ESAs to achieve a target hemoglobin of 12 g/dL or greater in cancer patients:
• shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy;

http://www.medpagetoday.com/ProductA...ptions/tb/5231

ROCKVILLE, Md., March 9 -- The FDA warned today that aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to a target of 12 g/dL or higher was associated with "serious and life-threatening side-effects and/or death."

I had some of this information posted somewhere else but I don't think it was being seen. I think this is the reason that they are changing the parameters for dosage. Please check out the full information at the links I provided.

Leslie