Safety Alerts & Recalls

What does this mean?

The increased risk of death, heart attack, and stroke related to the use of ESAs to treat anemia of any cause has been known from some time and doctors are aware of this risk. If you are receiving doses of Epogen, Procrit, or Aranesp for anemia, this is a good reminder that you and your doctor should regularly weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions against the increased risks for serious adverse events. Please attend your routine doctor's appointments so your health can be monitored with blood tests while using ESAs. The test results may help guide treatment and lower the risks of using these drugs. Your healthcare provider will indicate how often to have blood tests.

Please read the ESA Medication Guide which contains information on the benefits and risks of using these drugs:

Epogen: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088591.pdf

Procrit: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM088988.pdf

Aranesp: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM085918.pdf

If you have any questions or concerns about ESAs, please discuss them with your healthcare provider. Healthcare professionals and patients are encouraged to report side effects related to the use of their medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Modifies Dosing Recommendations for Erythropoiesis-Stimulating Agents

In order to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs), the Food and Drug Administration (FDA) today recommended more conservative dosing guidelines for when these medicines are used to treat anemia in patients with chronic kidney disease (CKD). ESAs are approved to treat some forms of anemia resulting from CKD, chemotherapy and certain other conditions. ESAs are synthetic versions of a human protein known as erythropoietin, which stimulates cells in the bone marrow to produce red blood cells, the main oxygen-carrying cells in the blood. Blood hemoglobin is a laboratory measure of the number of red blood cells in the blood. Anemia is an abnormally low hemoglobin value. Drugs in the ESA class are epoetin alfa, marketed as Epogen and Procrit, and darbepoetin alfa, marketed as Aranesp.

The modified recommendations are being added to the Boxed Warning and other sections of the prescribing information in response to clinical studies showed CKD patients experienced greater risks for death, heart attack, and stroke when ESAs are dosed to target a normal or nearly normal blood hemoglobin level, typically targeted to the range of 10 to 12 grams/deciliter (g/dL). In addition, ESAs have not been shown to improve quality of life, fatigue, or patient well-being. The modified prescribing labels remove this previous concept of a “target hemoglobin range.” ESA labels now recommend that doctors individualize dosing and use the lowest dose of ESA able to reduce the need for red blood cell transfusions.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-06-24
Last Updated: 2011-06-24

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