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Epoetin alfa, Darbepoetin alfa: Hemoglobin Target above 12 g/dL Increases Cardiovascular Risk
November 17, 2006
The FDA is warning healthcare professionals of an increased risk of cardiovascular complications with use of erythropoietic agents. A new study published in the New England Journal of Medicine shows increased cardiovascular risk of erythropoietic therapy with hemoglobin target greater than 13.5 g/dL. In the group randomized to a target of 13.5 g/dL the composite event rate was 125/715 (17.5%), compared to 97/717 (13.5%) in the group randomized to a target of 11.3 g/dL. The study supports hemoglobin targets no greater than 12 g/dL for therapy with any erythropoietic agent including epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp).
Additional information is available from the following links:
- Information for Healthcare Providers (historical information only):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126488.htm - Public Health Advisory (historical information only):
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm124140.htm - The CHOIR Study, published in N Engl J Med 2006;355:2085-2098:
http://content.nejm.org/cgi/reprint/355/20/2085.pdf (access restricted to subscribers or University of Utah Campus)
Updated
November 17, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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