Bad news continues to roll in about erythropoietin-stimulating agents (ESAs). According to the Food and Drug Administration (FDA), data from two new studies show increased tumor growth or earlier death among patients with breast cancer or advanced cervical cancer who received ESAs to treat chemotherapy-related anemia.
   These studies add weight to a half-dozen others used to strengthen ESA label warnings in November 2007. Taken together, the eight studies show that ESA treatment tends to increase tumor growth or shorten survival for patients with breast, non–small-cell, head and neck, lymphoid, or cervical cancers at doses aimed to achieve a hemoglobin level of 12 g/dl or greater, although many patients did not reach that level.
   FDA officials plan to discuss the data further and consider revising ESA labels again.
   ESAs are bioengineered versions of a protein made by the kidneys that stimulates bone marrow to produce more red blood cells. These drugs are approved for treating anemia in patients with chronic kidney failure; cancer patients whose anemia results from chemotherapy; and HIV-infected patients whose anemia results from treatment with zidovudine. ESAs are also approved to reduce the number of transfusions needed during and after major surgery.

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