FDA Announces Changes to ESA Labeling
November 8, 2007 – The U.S. Food and Drug Administration (FDA) today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs.) These new statements address the potential risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.
Today’s new labeling emphasizes that no clinical data is available to determine whether there is a similar risk of shortened survival or increased tumor progression for patients with cancer who receive an ESA dose intended to achieve a hemoglobin level less than 12 g/dL. Also, the revised labeling emphasizes there are no data from controlled trials demonstrating ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or with HIV undergoing AZT therapy. The new labeling does not stipulate a starting dose or range but only a upper safety limit of a hemoglobin of 12 g/dL and reflects FDA’s belief that physicians should use the lowest dose of ESAs to avoid transfusion.
A pre-published copy of the "ASH-ASCO 2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin" is available in ASH’s scientific journal, Blood.
Information from the FDA on erythropoiesis-stimulating agents is available, including:
|
