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Alert Number 70

Aranesp Warning – The Dark Side of Epo

Date: January 21, 2005

In November of 2003 we published an article titled The Dark Side of Epo on Topics, alerting our readers to the potential risks involved in over use of epoetin-based drugs. The link to our article is given below. If you have not read this article yet, I suggest you do so now.

On January 11, 2005, Amgen (manufacturer of Aranesp) sent out one of their "Dear Doctor" letters, as required by the FDA. (Sounds like CLL Topics was a little ahead of the FDA, by about a year, give or take. It feels good to be vindicated!) Aranesp is used in treating low levels of hemoglobin, either as a consequence of disease or therapy. Since low hemoglobin levels are a matter of life or death (certainly quality of life!) for CLL patients, this is an important issue for us. You can read the full text of the Amgen letter by clicking on the link at the bottom of this Alert.

Aranesp belongs to the class of growth factors called erythropoietic drugs (often abbreviated to epo or epoetin). Two recent studies with other drugs in the same class of Aranesp have shown that using the drugs at higher-than-recommended doses increases the risk of adverse effects including blood clots and death. Overkill use of any growth factor is not a good thing, in my opinion, and this letter says it the case with epo drugs as well. Our article also gives links to other studies that suggest this growth factor may also accelerate the rate at which cancers grows back, perhaps as a consequence of accelerated angiogenesis.

Anemia is a common side effect of chemotherapy, which can damage the production of red blood cells. In the case of CLL, anemia can also be due to crowding out of the red blood cell production in the bone marrow by too many CLL cells, or the red blood cells getting attacked and killed by an immune system gone berserk, as in the case of autoimmune hemolytic anemia (AIHA). Yet another reason for anemia could be due to incorrect functioning of the spleen, where red blood cells can get sequestered for no good reason. Independent of the root cause of the anemia, you will know when you are anemic: your body will tell you of this condition in no uncertain terms, well ahead of any blood test. Red blood cells and the hemoglobin they contain are the crucial transport system for oxygen in your body. Without it each and every cell in your body will be suffocating for lack of air. Low levels of hemoglobin will cause fatigue, difficulty carrying out the simplest tasks and a real loss of quality of life. Left untreated, it can cause death. If you are anemic, do not let this warning keep you from getting the treatment you need to correct the problem.

However, too much of a good thing is not good. The prescribing information for Aranesp indicates that the target hemoglobin level should not exceed 12 g/dL. In these studies, doctors used higher doses of the drug to achieve hemoglobin levels of greater than 12 g/dL, which subsequently increased the risk of blood clots and death. This warning is all about overkill. It is important to get the right perspective on things, getting a pragmatic balance between risks and rewards.

Be well.


Safety Warning

Tumor Growth Factor Potential

"Amgen has updated the safety information in the Aranesp prescribing information to reflect results from two recent investigational studies with other erythropoietic products (ie, epoetin alfa [Eprex] and epoetin beta [NeoRecormon], conducted outside the US, where patients with cancer were treated to higher hemoglobin target levels beyond the correction of anemia in those patients. These studies permitted or required dosing to achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events were reported in these studies."

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