Safety Alerts & Recalls

What does this mean?

The FDA has issued a statement today announcing changes to the approved product label for Epoetin Alfa. Epoetin Alfa is most commonly used to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer.

The new label changes for patients with cancer emphasize that:

- Epoetin Alfa has not been shown to improve symptoms of anemia, fatigue and quality of life in patients with cancer

- Studies have shown that shortened survival and increased cancer progression when drugs like Epoetin Alfa were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients;

- Not enough information is available regarding the risks of using DRUG NAME to achieve hemoglobin levels of less than 12 g/dL in cancer patients;

The new label changes for patients with chronic kidney failure emphasize that:

- Epoetin Alfa should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL in patients with chronic kidney failure, and that maintaining higher hemoglobin levels increases the risk of serious cardiovascular reactions such as stroke, heart attack or heart failure.

For more information, please visit:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109375.htm

Strengthened box warning for cancer and chronic kidney failure

The FDA has issued a statement today announcing changes to the approved product label for Epoetin Alfa. Epoetin Alfa is most commonly used to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer.

The new label changes for patients with cancer emphasize that: - Epoetin Alfa has not been shown to improve symptoms of anemia, fatigue and quality of life in patients with cancer

- Studies have shown that shortened survival and increased cancer progression when drugs like Epoetin Alfa were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients;

- Not enough information is available regarding the risks of using Epoetin Alfa to achieve hemoglobin levels of less than 12 g/dL in cancer patients;

The new label changes for patients with chronic kidney failure emphasize that: - Epoetin Alfa should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL in patients with chronic kidney failure, and that maintaining higher hemoglobin levels increases the risk of serious cardiovascular reactions such as stroke, heart attack or heart failure.

For more information, please visit: more information here

Source: FDA
Publication Date: 2007-11-09
Last Updated: 2010-04-13

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