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FDA Orders Changes to Labels of Erythropoiesis-Stimulating Agents
The Food and Drug Administration has ordered changes to the labeling of epoetin alfa (marketed as Procrit, Epogen) and darbepoetin alfa (marketed as Aranesp), restricting their use.
The agency said it had instructed the manufacturer to change the labeling to reflect three major changes:
- The drugs are "not indicated for those receiving myelosuppressive therapy when the anticipated outcome is cure."
- Therapy should not be initiated at hemoglobin levels of 10 g/dL and above.
- Doses should be withheld if hemoglobin levels exceed a level needed to avoid transfusion.
LINK(S):
FDA announcement (Free)
Published in Physician's First Watch July 31, 2008
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