Anemia Drugs Change Black Box Warning
FDA Approves Revision to Warning Label for Procrit, Aranesp, and Epogen Anemia Drugs
Nov. 8, 2007 -- The FDA today approved revisions to a "black box"
warning and other safety-related label changes for the anemia drugs Procrit, Aranesp,
Those drugs are erythropoiesis-stimulating agents (ESAs). They boost
production of red blood cells.
The revisions expand labeling
changes made in March 2007, which emphasize using the lowest possible dose
of the drugs to avoid the need for a blood transfusion.
Highlights in the revised warning include:
- Risks for certain cancer patients
- Risks for patients with chronic kidney failure
- A statement that ESAs haven't been shown to improve symptoms of anemia, fatigue, and quality of life
in cancer patients.
"FDA strongly recommends that prescribers talk to their patients about
the risks that ESAs might cause cancers to grow more quickly or shorten
survival before they prescribe these drugs or continue ESA therapy. These risks
should be weighed against the potential for red cell blood transfusion and
their associated risks," the FDA's Richard Pazdur, MD, said in a news
Pazdur directs the FDA's Office of Oncology Drug Products.
Procrit, Aranesp, and Epogen
ESAs are approved for treating certain cases of anemia, including in some
cancer patients and people with chronic kidney failure.
Epogen and Procrit are also approved for use in certain anemia patients who
are scheduled to undergo major surgery to reduce blood transfusions during or
shortly after surgery and for the treatment of anemia caused by zidovudine
(AZT) therapy in people with HIV, the virus that causes
ESAs and Cancer
For cancer patients, the new boxed warnings emphasize that ESAs caused tumor
growth and shortened survival in patients with advanced breast, head and neck,
lymphoid, and non-small-cell lung cancer when they received a
dose that attempted to achieve a hemoglobin level of 12 grams per deciliter
(g/dL) or greater.
The boxed warnings also emphasize that no clinical data are available to
determine whether there is a similar risk of shortened survival or increased
tumor growth for cancer patients who receive an ESA dose that attempts to
achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level
commonly achieved in clinical practice.
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.