THE NATIONAL KIDNEY FOUNDATION ANSWERS PATIENTS’ CONCERNS ABOUT ANEMIA TREATMENT

[okarol]

March 2007

THE NATIONAL KIDNEY FOUNDATION ANSWERS
PATIENTS’ CONCERNS ABOUT THE FDA BLACK
BOXED WARNING ON ANEMIA TREATMENT

The Food and Drug Administration (FDA) recently
issued a Black Boxed Warning about the safety of
drugs called Erythropoiesis-Stimulating Agents (ESAs)
for the treatment of anemia. You may know these
drugs as EPO. The National Kidney Foundation (NKF)
understands that patients may have concerns about
starting or continuing to use ESAs after hearing about
the FDA’s safety warning.
The purpose of these “Frequently Asked Questions”
is to help chronic kidney disease (CKD) patients
understand the risks and benefits of ESAs for
treating anemia and to address concerns you may
have about these drugs.
1. WHAT IS ANEMIA?
Anemia means there is a low supply of red blood
cells in the body. Red blood cells carry oxygen from
your lungs to all your organs and tissues. They
provide energy for your daily activities. Having
anemia may make you feel tired, look pale, and feel
short of breath. Many patients with chronic kidney
disease have anemia because their kidneys fail to
make enough of a certain hormone. This hormone
is called erythropoietin. Erythropoietin helps bone
marrow make red blood cells.
2. WHAT IS HEMOGLOBIN?
Hemoglobin is the part of the red blood cell that
carries oxygen. Iron is important for making
hemoglobin. Doctors measure your hemoglobin
level to check if you have anemia. Doctors also use
this test when treating anemia to make sure that
the hemoglobin level does not become too low or
too high.
3. WHAT IS AN FDA BLACK BOXED
WARNING AND WHY WAS ONE ISSUED
FOR ESAS?
Black Boxed Warnings are used by the FDA on drug
labels to warn users of serious risks that can happen
when using a drug product. The drug package
insert and ads for drug products with Black Boxed
Warnings must present these serious risks in a way
that stands out and is easy to notice.
A Black Boxed Warning was issued for ESAs
because of recent studies that showed an increased
risk of death, blood clots, strokes, and heart attacks
in patients with CKD (not on dialysis) who used
ESAs to treat anemia. The higher risks were seen in
patients receiving ESAs at doses designed to raise
the hemoglobin higher than the FDA-recommended
limit of 12. The Black Boxed Warning also applies to
the use of the ESA to treat anemia in patients who
are on dialysis.
In other studies, patients with anemia caused by
treatment for head and neck cancers, those with
cancer who were not receiving chemotherapy,
and patients who had orthopedic surgery all had
poor results after ESA treatment for anemia. These
results do not apply to most patients with chronic
kidney disease.
4. WHAT DRUGS ARE AFFECTED BY
THE FDA BLACK BOXED WARNING ON
ANEMIA TREATMENT?
Drugs affected are ESAs called Aranesp, Epogen
and Procrit. These drugs are used to treat anemia in
chronic kidney disease and other diseases.

NKF 30 East 33rd Street, New York, NY 10016 • (800) 622-9010 • (212) 889-2210 • Fax (212) 889-2310 • www.kidney.org