Safety Alerts & Recalls

What does this mean?

This alert is to remind you that serious risks have been associated with the use of ESAs, such as Darbepoetin Alfa, in patients with cancer. If you are receiving Darbepoetin Alfa for the treatment of chemotherapy related anemia, you and your doctor should regularly review the benefits of treatment versus the risk.

Two Recent Studies Support Safety Concerns of Erythropoiesis Stimulating Agent Use in Cancer Patient

Two recently published studies in the Lancet and the Canadian Medical Association Journal support previously released FDA statements about the increased risk of death associated with using of erythropoiesis stimulating agents (ESAs) such as Aranesp, Epogen, or Procrit, in cancer patients. In cancer patients, ESAs are used to treat anemia, a condition where the level of hemoglobin in red blood cells is too low, resulting in stress on bodily organs.

ESAs already have an FDA required black-boxed warning related to an increase risk of death, heart attack, stroke, and tumor progression or recurrence associated with the use of these products. To assist patients in better understanding the risk of ESA use, the FDA recently approved Medication Guides for these products. The FDA has published available information about ESAs on the following website: more information here

For more information about the recent journal articles, please visit: more information here and

more information here

Source: MediGuard CRT
Publication Date: 2009-08-27
Last Updated: 2009-12-05

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