The Wall Street Journal-20080131-Daiichi Sankyo Co-- Anemia Drug-s Death Rate Prompts Panel Review

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Daiichi Sankyo Co.: Anemia Drug's Death Rate Prompts Panel Review

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The Food and Drug Administration said Injectafer, a proposed drug by a unit of Daiichi Sankyo Co., had a higher death rate among patients in clinical studies. Injectafer was developed by Daiichi's Luitpold Pharmaceuticals to treat anemia in patients with heavy bleeding after childbirth or from other conditions. The drug faces a review tomorrow, where medical experts will discuss the "mortality safety signal," the FDA said. The drug was used in two clinical studies involving 2,000 patients. The FDA said there were 10 deaths in the Injectafer group, compared with one in the control group.