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FDA Releases Questions and Answers about ESA Medication Guides

The Food and Drug Administration now provides answers to questions about using erythropoiesis-stimulating agents (ESAs) and their FDA-approved Medication Guides.  The Medication Guides are now part of labeling for ESAs Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa), and Procrit® (epoetin alfa).

The Guides are designed to help patients make informed decisions about the risks and benefits of using ESAs and to give them a starting point for discussions with their doctors.  The Medication Guide must be given to directly patients or their caregivers at the time an ESA is dispensed.

Erythropoiesis-stimulating agents trigger the bone marrow to produce more red blood cells when anemia is due to low red cell counts.   For cancer patients, ESAs are only used during chemotherapy to reduce the need for blood transfusions.  They are not appropriate for anemic cancer patients who not are having chemo, nor are they approved for chemotherapy patients whose treatment goal is cancer cure.

The FDA tells cancer patients who are considering ESA treatment that

  • The tumor may grow faster and the patient may die sooner when ESA treatment is used.
  • The healthcare provider should prescribe the lowest dose of the ESA that is needed to avoid red blood cell transfusions.
  • ESAs work by stimulating the bone marrow to make more red blood cells. ESAs have not been shown to improve the symptoms of anemia, quality of life, fatigue, or well-being for patients with cancer.   For that reason, ESAs should be used only to reduce the chance that a patient with low red blood counts (anemia) will get a blood transfusion.
  • Treatment with an ESA should be stopped when chemotherapy treatment is finished.

The Medication Guides warn about the dangers of blood clots while using ESAs and tell patients to call their healthcare provider or get medical help right away if they have any of these symptoms of blood clots:

  • Chest pain
  • Trouble breathing or shortness of breath
  • Pain in the legs, with or without swelling
  • A cool or pale arm or leg
  • Sudden confusion, or trouble speaking or understanding speech
  • Sudden numbness or weakness of the face, an arm, or leg, especially on one side of the body
  • Sudden trouble seeing
  • Sudden trouble walking, dizziness, loss of balance or coordination
  • Loss of consciousness (fainting)

There is also risk of serious heart problems such as heart attack, stroke, heart failure, and a higher chance of death if patients are treated with an ESA to a hemoglobin level above 12 g/dL.

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