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FDA Strengthens Warnings on Erythropoiesis-Stimulating Drugs
The FDA has approved additional boxed warnings and label updates for the erythropoiesis-stimulating agents Aranesp, Epogen, and Procrit.
The new warnings note that when the drugs were dosed to achieve hemoglobin levels over 12 g/dL, they stimulated tumor growth and decreased survival in patients with advanced breast, head and neck, lymphoid, and non-small cell lung cancer. (Higher mortality and tumor progression have not been ruled out at levels under 12 g/dL.)
When used to maintain hemoglobin levels over 12 g/dL in patients with chronic renal failure, the drugs increased the risk for death, stroke, heart attack, and heart failure. In these patients, the FDA recommends aiming for hemoglobin levels between 10 and 12 g/dL.
LINK(S):
FDA press release (Free)
Physician's First Watch coverage of initial FDA warning, dosing change for erythropoietin (Free)
Published in Physician's First Watch November 9, 2007
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