FDA ALERT FOR ARANESP PLEASE READ!!!!

[RandyW]

This is posted oin other forums but I want to make sure the most people see this as is possible..

DEb had so many shots of this and I am Devastated to readd and Hear this today after dealing with another drug that caused 2 death in Charlotte NC Last year.

Information on Erythropoiesis Stimulating Agents (ESA)

(marketed as Procrit, Epogen, and Aranesp)

FDA ALERT [11/16/2006]

FDA is issuing this alert to advise you 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” (CHOIR) 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 CHOIR 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

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Healthcare Professional Information

Healthcare Professional Sheet [PDF] or

Prescribing Information

Epogen and Procrit label and approval history for Drugs@FDA

Aranesp label and approval history for Drugs@FDA

Other Information

Public Health Advisory

Report Adverse Events to MedWatch

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Date created: November 16, 2006

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Maybe instead Of suing the Tobacco companies for Giving People Lung Cancer, We should think about the Companies Trying to save us from the ones trying to kill us with ther products. WHERE DOES THIS END??????????????????????????

[Linda661]

Randy:

Thanks so much for the timely alert. Unfortunately, I always assumed that this is exactly why we need to stay informed ourselves and proactively advocate so hard on what goes on with our medical care.

Linda

[marym]

I have been given arenesp many times, but only if my hemo was below 12. I think that must have been a guidline for some time, or at least it was with my doctor.

Mary

[RandyW]

BUMPING FOR INFORMATION REASONS

[EastCoastLadi]

Thank you for the info Randy...

I just told my husband that I was going to discuss this w/ his onc. this week. He has been getting weekly procrit shots, but he has gotten arenesp before. It makes you wonder if sometimes the treatment for this awful disease can be as devistating as the disease itself..

Grace

[teriw]

Randy,

Thank you so much for taking the time to post this. It's so helpful.

I'm feeling a bit stupid at the moment, but does anyone know -- is it standard practice to dose to a target hemoglobin concentration of 13.5 g/dL (as opposed to the safer 11.3 g/dL)? Or is the former dosage considered to be "pushing it?"

I guess the best thing to do is print this report out and bring it to our docs, which is what I plan to do.

Thanks again Randy.

[stand4hope]

It makes you wonder if sometimes the treatment for this awful disease can be as devistating as the disease itself..

Dear Grace,

Sometimes it is!

Love,

Peggy