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JNCI Journal of the National Cancer Institute 2007 99(10):746-753; doi:10.1093/jnci/djk216
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© Oxford University Press 2007.

NEWS

Amid Health Concerns, FDA Reviews Safety of Several Heavily Used Anemia Drugs

Rabiya S. Tuma

The first 150 words of the full text of this article appear below.

For the second time in 3 years, the U.S. Food and Drug Administration is reviewing the safety of a class of widely used anemia drugs. Earlier this year, the agency added the highest level of warning, a so-called black box, to the label of all three erythropoiesis-stimulating agents (ESAs). At the request of the agency, the Oncologic Drug Advisory Committee (ODAC) met last week to evaluate the drug's safety and dosing.

The new wave of concern was triggered by the release of data from several randomized controlled trials, which showed that patients taking ESAs might be at higher risk of heart attacks or death if their target hemoglobin was above a certain level. Three of the trials were shut down early because of concerns about the health risks. This added to results from two previous studies that also suggested there were problems.

Three ESAs, all forms of the human hormone . . . [Full Text of this Article]


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