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Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit and Epogen), Darbepoetin alfa (marketed as Aranesp)

11/8/2007

FDA has approved revised labeling for the ESAs that clarifies how to safely and effectively use these products and to strengthen the information about risks from using ESAs. These changes reflect the advice FDA heard from two advisory committee meetings held this year. The information and guidance for doctors and patients that is in the revised labeling is summarized below.

Patients with cancer who are currently using or considering the use of an ESA should know the following:

  • 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 other  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

Patients with chronic kidney failure (this includes both patients on dialysis and those not on dialysis) who are currently using an ESA should know the following:

  • Your hemoglobin level should be checked regularly to make sure it stays between 10 and 12 g/dL.
  • ESAs can increase your chance of heart attack, stroke, blood clots, heart failure, and death when they are given to maintain higher hemoglobin levels.
  • If you are not responding to treatment with an ESA (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 for HIV and are being treated with an ESA for your anemia, you should be aware that there is no evidence that ESAs lessen the symptoms of anemia, such as fatigue.

All patients should talk with their health care provider about any concerns or questions you may have concerning the use of ESAs.

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 & 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 ESAs to patients.  

FDA-approved uses of ESAs 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 AZT (zidovudine), and to reduce the number of transfusions during and after major surgery (except heart surgery).

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
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