FDA Issues Updated Advisory Regarding Use of Red-blood Cell Boosters

Cancer Connect

Based on advice from two advisory committees, the U.S. Food and Drug Administration (FDA) has approved revised labeling for erythropoiesis-stimulating agents (ESAs). ESAs are drugs used to treat anemia and include Procrit® (epoetin alfa), Epogen® (epoetin alfa), and Aranesp® (darbepoetin alfa).

Anemia is a common side effect of chemotherapy and cancer. It is characterized by low levels of circulating red blood cells, which are responsible for delivering oxygen to tissues throughout the body. Severe anemia often requires treatment with blood transfusions.

ESAs stimulate the body to produce more red blood cells. Use of ESAs to treat anemia caused by chemotherapy has been shown to decrease the need for blood transfusions.

ESAs are approved for the treatment of anemia in chronic kidney failure patients, in patients with cancer whose anemia is caused by chemotherapy, in patients with HIV whose anemia is caused by AZT (zidovudine), and to reduce the number of transfusions during and after major surgery (except heart surgery).

Serious adverse effects of ESAs have been reported in certain groups of patients, and in March 2007 the FDA issued a Public Health Advisory about the use of these drugs. Since March two advisory committee meetings have been held. Based on advice from the advisory committees, the FDA issued another Public Health Advisory in November 2007 and approved revised labeling for ESAs.

For patients with cancer, the November 2007 Public Health Advisory makes the following points:[[1]](http://news.cancerconnect.com/fda-issues-updated-advisory-regarding-use-of-red-blood-cell-boosters/#_edn1 "_ednref1")

  • ESAs may shorten your survival time or may cause your tumors to grow faster.
  • ESAs should only be used to treat anemia caused by chemotherapy and not anemia from other causes in patients with cancer.
  • ESAs should not be used to treat the symptoms of anemia, such as fatigue, or improve the quality of life in patients with cancer. The goal of treatment with ESAs is to avoid blood transfusions.
  • Treatment with an ESA should be stopped after you complete your course of chemotherapy.

The studies that reported increased tumor growth or decreased survival with ESAs targeted a hemoglobin level that is higher than the approved level. Nevertheless, the FDA notes that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer 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.[[2]](http://news.cancerconnect.com/fda-issues-updated-advisory-regarding-use-of-red-blood-cell-boosters/#_edn2 "_ednref2")

In spite of concerns about the potential for more rapid tumor progression or shortened survival, the FDA notes: ESA products do have an important supportive role in the treatment of patients with cancer who are undergoing chemotherapy. There is no doubt that use of ESAs in that setting reduces the need for a blood transfusion. The current labeling provides flexibility for patients and physicians to decide whether the use of an ESA is appropriate in each individual case [[3]](http://news.cancerconnect.com/fda-issues-updated-advisory-regarding-use-of-red-blood-cell-boosters/#_edn3 "_ednref3")

The FDA recommends that cancer patients discuss this information with their physician before beginning or continuing ESA treatment.

References:

[[1]](http://news.cancerconnect.com/fda-issues-updated-advisory-regarding-use-of-red-blood-cell-boosters/#_ednref1 "_edn1") U.S. Food and Drug Administration. FDA Public Health Advisory. November 8, 2007. Available at: http://www.fda.gov/cder/drug/advisory/RHE200711.htm (Accessed November 9, 2007).

[[2]](http://news.cancerconnect.com/fda-issues-updated-advisory-regarding-use-of-red-blood-cell-boosters/#_ednref2 "_edn2") U.S. Food and Drug Administration. FDA News. FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs). November 8, 2007. Available at: (Accessed November 9, 2007).

[[3]](http://news.cancerconnect.com/fda-issues-updated-advisory-regarding-use-of-red-blood-cell-boosters/#_ednref3 "_edn3") U.S. Food and Drug Administration. Questions and Answers for Erythropoiesis-stimulating Agents (ESAs) Labeling Changes. November 8, 2007. Available at: (Accessed November 9, 2007).

Related News:

Senate Asks Centers for Medicare and Medicaid Services to Review Restrictions on Erythropoietic Stimulating Agents (09/07/2007)

FDA Issues Advisory Regarding Use of Red-blood Cell Boosters (3/12/2007)

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