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FDA Warns on Erythropoietin, Changes Dosing
Erythropoiesis-stimulating agents (ESAs) should be given in the lowest possible dose required to gradually increase hemoglobin "to the lowest level sufficient to avoid the need for blood transfusions," according to an FDA alert.
The FDA said the ESAs — darbepoetin (Aranesp) and epoetin (Epogen and Procrit) — will carry updated warnings and new dosing instructions. Several recent studies suggest the agents can increase the risk for cardiovascular and thromboembolic events, as well as shorten the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy.
The FDA recommends measuring hemoglobin twice a week for 2 to 6 weeks after any dosage adjustment and withholding the dose if hemoglobin levels exceed 12 g/dL or rise by 1 g/dL in any 2-week period.
The agency said it believes "these new concerns apply to all ESAs and is re-evaluating how to safely use this product class."
Link: FDA alert (Free PDF)
Link: FDA press release (Free)
Link: Physician's First Watch coverage of earlier hemoglobin studies (Free)
Published in Physician's First Watch March 12, 2007
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