FRIDAY, June 24 (HealthDay News) -- Doctors should use the
anemia drugs Procrit, Epogen and Aranesp more cautiously in
patients with chronic kidney disease, U.S. health officials said
The new warning comes in response to data showing that patients
on these drugs face a higher risk of cardiovascular problems such
as heart attack, heart failure, stroke, blood clots and death, the
U.S. Food and Drug Administration said.
"FDA is recommending new, more conservative dosing recommendations for erythropoiesis-stimulating agents [ESAs] for patients with chronic kidney disease," Dr. Robert C. Kane, acting deputy director for safety in the division of hematology products, said during a news conference Friday.
These recommendations are being added to the drug label's black
box warning and sections of the package inserts, he said.
This is not the first time health risks have been linked to
these anemia drugs. They have also been tied to increased tumor
growth in cancer patients and may cause some patients to die
sooner. Also, cancer patients have an increased risk of blood
clots, heart attack, heart failure and stroke, according to the
Procrit, Epogen and Aranesp are synthetic versions of a human
protein known as erythropoietin that prods bone marrow to produce
red blood cells. The drugs are typically used to treat anemia in
cancer patients and to reduce the need for frequent blood
transfusions. Anemia also occurs in patients with chronic kidney
disease. Anemia results from the body's inability to produce enough
red blood cells, which contain the hemoglobin needed to carry
oxygen to the cells.
Currently, labels on these drugs say ESAs should be used to
achieve and maintain hemoglobin levels within 10 to 12 grams per
deciliter of blood in patients with chronic kidney disease. These
target levels will no longer be given on the label, the agency
Hemoglobin levels greater than 11 grams per deciliter of blood
increases the risk of stroke, heart attack, heart failure and blood
clots and haven't been proven to provide any additional benefit to
patients, according to the FDA.
The new label says that for patients with chronic kidney disease
not on dialysis, ESA therapy can be started when the hemoglobin
level is less than 10 grams per deciliter. However, the goal of
treatment should not be to increase hemoglobin levels to 10 or more
grams per deciliter. Treatment needs to be individualized for each
patient, the FDA said.
For patients on dialysis, ESA therapy can start when the
hemoglobin level is less than 10 grams per deciliter. But, if the
hemoglobin level approaches or goes over 11 grams per deciliter,
the dose of the drug should be lowered or therapy stopped, the
Doctors should prescribe the lowest possible dose needed to
reduce the need for transfusions, the agency added.
Patients taking these drugs should read the information in the
medication guide included with these drugs. They should also have
frequent blood tests, which help doctors keep hemoglobin at safe
If patients have concerns about these drugs, they should consult
with their doctor, the FDA said.
Amgen Inc., the maker of all three drugs, said in a news release
that it backs the FDA action.
"Amgen supports the modified ESA prescribing information as it informs physicians of important safety information," Dr. Roger M. Perlmutter, Amgen's executive vice president of research and development, said in the news release. "The revised label also provides physicians with more individualized treatment guidance by distinguishing between patients undergoing dialysis as compared with those who are not on dialysis."
The U.S. Centers for Disease Control and Prevention estimates
that more than 20 million Americans aged 20 and older suffer from
chronic kidney disease.
To learn more about ESAs, visit the
U.S. Food and Drug Administration.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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