FDA Warning - Procrit, Epogen, and Aranesp

[Black]

"Erythropoiesis Stimulating Agents
Procrit, Epogen, and Aranesp

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."

http://www.fda.gov/medwatch/safety/2006/safety06.htm#erythropoiesis

[Rerun]

Hmmmmmm maybe the price will go down! 

Very interesting, Thank you Black.

[Zach]

I think the price will go up.   

[kitkatz]

Can you translate the medical goup into English?  What did that mean?

[Rerun]

What I think it means is that using too much Epogen to keep your hemoglobin to target of 13.5 like all the doctors and Pharmaceutical  companies want you to is now showing adverse complications.  They are saying to lower the dose so your hemoglobin is around 11.3.  They are lowering the target hemoglobin.  So, Zach is right the price will go up because we won't be using as much!   

[RichardMEL]

Question: down here my hemo is in measures around 100, 110 etc.. they suggest 130 is normal and put me on anaresp when I was down to 90 or so. I am presuming this is just 10x the figures mentioned above, and so I should really be looking for a target of 110-120? My last labs had me at 112 so I guess I'm doing OK there. Must ask the doc

[BigSky]

Typical governement day late and dollar short.

The information of increased risk  is in the clinical pharmacology information of the drug.

[stauffenberg]

It has been well-established since the mid 1980s that EPO is dangerous if used to normalize hemoglobin levels.  Normal hemoglobin for a male is 140 to 170, so all males on dialysis are SEVERELY anemic, since they are usually kept at a level around 110-120.  A hemoglobin of 90 is defined as the 'bed rest' level, meaning that a hospital patient with that low a level should not be allowed out of bed, but many dialysis patients are expected to walk around and somehow function at that level.  For women the situation is still inadequate but not so severe, since normal hemoglobin for a woman ranges from 120 to 140, so they are not so far below normal while on dialysis as men are.l

[Joe Paul]

It has been well-established since the mid 1980s that EPO is dangerous if used to normalize hemoglobin levels.  Normal hemoglobin for a male is 140 to 170, so all males on dialysis are SEVERELY anemic, since they are usually kept at a level around 110-120.  A hemoglobin of 90 is defined as the 'bed rest' level, meaning that a hospital patient with that low a level should not be allowed out of bed, but many dialysis patients are expected to walk around and somehow function at that level.  For women the situation is still inadequate but not so severe, since normal hemoglobin for a woman ranges from 120 to 140, so they are not so far below normal while on dialysis as men are.l

Intresting.

[RichardMEL]

That is VERY interesting to me. My doctor started me on Anaresp when my level hit 90 and he didn't seem too concerned about it other than "it was time" and he seems quite happy with my level being around 110-120. When I was on 90 I  can't say I felt a hell of a lot worse/more tired than I do now. There was some suggestion I should feel a burst of more energy... I guess I feel a little bit better, but I am not about to start running marathons. Still I feel mostly normal (well normal being defined as "OK for someone with kidney failure") - I'm not about to keel over or anything but I would love more energy. Oh well.

Very interesting reading...

[jbeany]

Richard - how are your iron levels?  I was on Aranesp and Procrit for years, but didn't see any real difference in my actual energy levels until I started iron transfusions.  My iron levels before were always down so low, it was practically a negative number. (6 or 10 when it's supposed to be 100-800)

[RichardMEL]

Iron levels? Not sure - will have to peek in my folder tomorrow at dialysis to see - I do know they have me an iron shot last week so I am guessing it was lowish.... I couldn't be bothered to ask when they came to put it in. They just said "iron" and I nodded and said "Ok" but didn't really think much of it since they said I'd need iron from time to time so I kind of assumed it was just another part of being on dialysis.

I shall have a peek at the latest test results and check where I am at.

[jbeany]

For some reason, I only have energy if my iron levels are up, regardless of how high my hemogloblin actually is.  I don't know if that's true for everyone, but it's worth looking into, I think.

[jedimaster]

My hemoglobin level is now 90...and I feel VERY tired most of the time. I just had my monthly clinic and thy increased my Aramesp from .5 weekly to .8 weekly.....Usually if I'm around 120 I feel WAY better...

[RichardMEL]

I am on Anaresp 40 every 10 days.. seems to keep me between 110-120.

[Zach]

so all males on dialysis are SEVERELY anemic, since they are usually kept at a level around 110-120.

Despite stauffenberg's gloomy pronouncements, most of us men on dialysis do fine with a hemoglobin between 110-120.  Along with Hemoglobin, Serum Ferritin and Transferrin Saturation %, as well as one's nutritional intake are all part of the equation of what gives us enough energy to do things.

[Lucinda]

You are definitely in a more dangerous zone if your hemoglobin is over 120. Mine was up to 140 and I felt brilliant but it was dangerously high so had my dosage cut and now hang between 110 and 120 which is the safe zone.  Anything higher and you put a big risk on your heart.  I was taking the same as Richard but now I am on 20 of Aranesp every two weeks and that tends to keep me at a safe level. 

[Razman]

You are definitely in a more dangerous zone if your hemoglobin is over 120. Mine was up to 140 and I felt brilliant but it was dangerously high so had my dosage cut and now hang between 110 and 120 which is the safe zone.  Anything higher and you put a big risk on your heart.  I was taking the same as Richard but now I am on 20 of Aranesp every two weeks and that tends to keep me at a safe level. 

Here is a comment that I recevied from a doctor.  :
Most studies do not support HGB beyond 120. However, there are some data that suggest higher HGB might be safe IF large doses of EPO are not requried to attain these levels. This information is still preliminary, though, I agree with your sentiment, that a "one size fits all approach" is probably not universally valid.

Having said that, the current guidelines advise 120 as high threshold. If a patient preferred and felt better at a higher number s/he would have to accept being advised by their practitioner that there MAY be increased risk of cardiovascular events by doing so.

Talk to your doctor .  You may be able to go higher if required.