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Erythropoiesis-Stimulating Agents (ESAs) 11.0807 - Full Version

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On November 8, 2007, the Food and Drug Administration issued a public health advisory titled: Erythropoiesis- [eh RITH ro POH eh sis] Stimulating Agents (E-S-As); known as Epoetin alfa [eh POH eh tin AL fa] (marketed as Procrit or Epogen) and Darbepoetin alfa [dar beh POH eh tin AL fa] (marketed as Aranesp).

I am Mandy Eisemann from F-D-A’s Center for Drug Evaluation and Research.

We have approved revised labeling for the E-S-As that clarifies how to safely and effectively use these products and to strengthen the information about risks from using E-S-As. These changes reflect the advice we heard from two advisory committee meetings held this year. Here is a summary of the information and guidance for doctors and patients that is in the revised labeling.

Patients with cancer who are currently using or considering the use of an E-S-A should know the following:

  • First, E-S-As may shorten your survival time or may cause your tumors to grow faster.
  • Second, E-S-As should only be used to treat anemia caused by chemotherapy and not other anemia from other causes in patients with cancer.
  • Third, E-S-As 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 E-S-As is to avoid blood transfusions.
  • Finally, treatment with an E-S-A should be stopped after you complete your course of chemotherapy.

Patients with chronic kidney failure--including both patients on dialysis and those not on dialysis--who are currently using an E-S-A should know the following:

  • First, your hemoglobin level should be checked regularly to make sure it stays between 10 and 12 grams per deciliter.
  • Second, E-S-As can increase your chance of heart attack, stroke, blood clots, heart failure, and death when they are given to maintain higher hemoglobin levels.
  • Finally, if you are not responding to treatment with an E-S-A, meaning your hemoglobin levels are not increasing, ask your doctor if you need to be checked for other causes of anemia.

If you are a patient taking Zidovudine [zye DOH vue deen] for HIV and are being treated with an E-S-A for your anemia, you should be aware that there is no evidence that E-S-As lessen the symptoms of anemia, such as fatigue.

All patients should talk with their health care provider about any concerns or questions they may have concerning the use of E-S-As.

Healthcare professionals should read the full prescribing information and the revised Information for Healthcare Professionals.

FDA and Amgen, the manufacturer of these products, and Ortho Biotech Products, L.P, a Johnson and Johnson Pharmaceuticals Research and Development subsidiary, the distributor of Procrit, have changed the labeling for Aranesp, Epogen, and Procrit to reflect the updated safety information and to provide additional instructions to both doctors and patients for their use. A Medication Guide is also being developed to better communicate the risks and benefits of E-S-As to patients.

FDA-approved uses of E-S-As are for the treatment of anemia: in patients with chronic kidney failure, in patients with cancer whose anemia is caused by chemotherapy, in patients with HIV whose anemia is caused by A-Z-T (zidovudine [zye DOH vue deen]), and to reduce the number of transfusions during and after major surgery, except heart surgery.

We are asking health care professionals and patients to report serious side effects after using E-S-As to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot G-O-V slash M-E-D-W-A-T-C-H.

Date created: November 8, 2007


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