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Alert Number 270

EPO Drugs - Not to Be Overused

PC and I would like to wish all our members a Happy New Year.  May 2008 bring you and your family good health and happiness.

We have been active in sounding the alarm for some years over indiscriminate and excessive use of erythropoietin drugs (brand names such as Aranesp, Epogen, Procrit) in an attempt to increase hemoglobin levels in patients with anemia.  Links to our earlier articles are given below, if you are a new member or have forgotten about these warnings.

CLL patients can be anemic for a variety of reasons.  Among them, a bone marrow so stuffed with CLL cells that it is not up to its job of making new red blood cells, bone marrow toxicity of chemotherapy agents used to treat CLL, autoimmune disease ( AIHA ) where red blood cells are unfairly attacked and killed by a sick immune system, a swollen spleen that traps and sequesters good red blood cells and takes them out of circulation.  Hey, it could also be garden variety anemia due to inadequate iron levels.

For whatever reason, having low hemoglobin levels has tremendous impact on quality of life.  People with low hemoglobin levels literally have to drag themselves out of bed, and the fatigue can be quite distressing.  In the past decade or so we have made amazing advances in developing man-made growth factors such as erythropoietin drugs that can goose the bone marrow into producing new red blood cells.  But it is important to remember a good thing is not necessarily better if you use more of it – and red blood cell growth factors fall into this category.  Glowing consumer-directed advertisements to the contrary, it is not a good idea to push those hemoglobin levels higher than absolutely necessary, in an attempt to regain the youthful vibrancy you lost a long time ago as you became older.

The reason for this Alert is the new FDA warning released today, citing the dangers of excessive use of erythropoietin drugs in the case of lymphoid cancer patients as well.  Until now, the only cancers cited have been solid tumors such as breast cancer, cervical cancer, head and neck cancers etc.  Now, there is little doubt that we fall into the same group, our guys too are at risk of dying sooner or having more aggressive disease, if chemotherapy induced anemia is treated with aggressive erythropoietin therapy.  Bugging your doctor to give you additional shots of Aranesp, Epogen or Procrit is not a good idea.  Sometimes the best thing to do is use as little of these drugs as you can get away with, then be patient while your bone marrow gradually recovers by itself.  

There is one type of “epo” that is very safe, has no risks whatsoever.  It is the epo your body makes by itself, when you participate in vigorous and regular exercise.  I know, it is hard to work out when you are anemic and it is hard to get out off of the sofa.  But every little bit helps, and the sooner you get going the better you will feel.  Gone are the days when patients are told to coddle themselves.  Discuss a sensible exercise plan with your doctor, and then get moving!  The life you save will be your own.

More Risks Seen With Use Of Epo Drugs (June 7, 2006)
Dark Side of Epo (Nov. 22, 2003)
Epo Drugs - Topics Alert Number 222 (March 9, 2007)

Be well,


News Report

FDA Reviews New Amgen, J&J Data

January 4, 2008

WASHINGTON -- The Food and Drug Administration said it is reviewing additional information submitted by Amgen Inc. and Johnson & Johnson involving risks associated with the antianemia drugs Aranesp, Epogen and Procrit and "may take" additional regulatory action.
The agency strengthened warnings on the widely used drugs twice last year and plans to hold another advisory-panel meeting in the next few months to discuss the new studies, which the agency said weren't included in the most recent label update of the drugs Nov. 8.
The FDA said the studies "provide further evidence of the risks of anemia drugs" known as erythropoiesis-stimulating agents, or ESAs. The companies released the study results in December.
The FDA said the studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more-rapid tumor growth than similar patients who didn't receive the anemia drugs.
The agency said the two new studies, along with six that are included in the current drug labels "show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared with patients who did not receive this treatment."
The agency said ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter or greater in the studies, which is higher than current dosing recommendations.
"This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer," which the FDA addressed in previous communications, said Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs.
She said the agency is recommending, for now, that health-care providers review the risks and benefits of ESAs outlined in the product labels and discuss the information with their patients.
Amgen makes all three antianemia drugs, and Procrit is marketed by Ortho Biotech, a Johnson & Johnson unit, under a license agreement with Amgen. The drugs treat anemia by boosting the number of red blood cells and are typically used to treat patients with kidney disease and certain cancer patients receiving chemotherapy.
Both Amgen and Ortho Biotech said they would continue to work closely with the FDA on any additional label updates and would continue to provide safety updates to health-care providers.

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