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FDA Issues New Anemia Drug Warnings

Law360 (March 12, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration has revised the product labeling for a class of biotech drugs used to treat anemia, dealing a blow to drug maker Amgen.

The FDA issued a black box warning—its strongest—Friday for Aransep, Epogen and Procrit, all erythropoiesis-stimulating agents or ESAs. The agency said that physicians should monitor red blood cell levels and carefully weigh the risks of using the drugs against transfusion risks.

The FDA said that recently completed studies of the drugs describe an increased risk of death, blood...
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