Source: National Anemia Action Council (www.anemia.org)
Author: staff

The U.S. Food and Drug Administration (FDA) ordered specific changes for the use of erythropoeisis-stimulating agents (ESAs) to treat anemia in patients receiving chemotherapy. The label changes will state treatment should only begin when a patient’s hemoglobin level drops to 10 g/dL and removes the mention of 12 g/dL as an upper hemoglobin level of treatment because the safety of ESA use at that level is not yet known. The labeling will also advise not to use ESAs when chemotherapy is given to cure patients, which based on a doctor’s discretion, could include treatment designed to prevent cancer from coming back.

The announced label changes reflect most of the recommendations from the Oncology Drugs Advisory Committee’s meeting March 13, 2008. Not included is advice from the committee to limit use of the drug for patients with breast cancer or head and neck cancer, despite recent studies showing more rapid tumor growth or shortened survival when these patients received treatment with ESAs.

The drug’s manufacturer, Amgen, announced the revised product labeling for ESAs will be released to both physicians and patients soon. The FDA and Amgen agreed on a majority of the new label, but could not reach agreement on a couple points, prompting the FDA to invoke new authority to mandate drug label changes.