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Addendum

Special Announcement (Updated September 3, 2008):Effective July 31, 2008, the Food and Drug Administration (FDA) mandated the following changes to the labels for the erythropoiesis stimulating agents epoetin alfa and darbepoetin:

• ESAs are no longer indicated for patients receiving myelosuppressive chemotherapy if the anticipated treatment outcome is cure. They remain indicated when myelosuppressive chemotherapy is intended for palliation.
• ESAs should not be initiated if the patient's hemoglobin is above 10 g/dL. Further, the label change
• specifies that ESA treatment should target the lowest hemoglobin concentration that will avoid transfusion,
• removes "...or exceeds 12 g/dL" as an upper range for ESA use, and
• removes language that allowed earlier initiation of ESAs, or treatment to higher hemoglobin targets, if the patient cannot tolerate anemia due to a co-morbid condition.

The labels' boxed warnings now read as follows: "ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers." The warning is no longer focused on studies with hemoglobin targets at or above 12 g/dL.

Special Announcement (Updated May 1, 2008): The US Food and Drug Administration (FDA) announced revisions to erythropoiesis-stimulating agent (ESA) product labels on November 8, 2007, when this guideline was in press. These revisions warn that data are not sufficient to exclude the possibility of shortened survival and tumor progression in cancer patients when ESAs are dosed to reach a hemoglobin (Hb) level between 10 and 12 g/dL. Clinicians are advised to consider this warning, as discussed in the guideline.

On March 12, 2008, the FDA posted the following information to its Web site: "Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL."

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