Anemia Drugs Change Black Box Warning
FDA Approves Revision to Warning Label for Procrit, Aranesp, and Epogen Anemia Drugs
WebMD News Archive
ESAs and Cancer continued...
Health care providers determine whether a patient is anemic and decide on
ESA dosing by measuring how much of the protein known as hemoglobin is present
in a patient's red blood cells.
An earlier boxed warning, approved in March, described the results of six
studies demonstrating that survival was shorter and tumors progressed faster
when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in
Today's new boxed warning also clarifies that ESAs should only be used in
patients with cancer when treating anemia specifically caused by chemotherapy
and not for other causes of anemia.
Moreover, the revised warning states that ESAs should be discontinued once
the patient's chemotherapy course has been completed.
ESAs and Chronic Kidney Failure
For patients with chronic kidney failure, the new boxed warning states that
ESAs should be used to maintain a hemoglobin level between 10 g/dL and 12
Maintaining higher hemoglobin levels in patients with chronic kidney failure
increases the risk of death and serious cardiovascular reactions such as stroke, heart attack, or heart failure, according to the
In addition to the boxed warning, the new labeling provides specific
instructions for dosage adjustments and hemoglobin monitoring for chronic
kidney failure patients who don't respond to ESA treatment with an adequate
increase in their hemoglobin levels.
The new labeling also emphasizes that there are no data from controlled
trials demonstrating that ESAs improve symptoms of anemia, quality of life,
fatigue, or patient well-being for patients with cancer or for patients with
HIV undergoing AZT therapy.
Procrit, Aranesp, and Epogen are made by Amgen. Procrit is sold by Ortho
Biotech, a subsidiary of Johnson & Johnson.