From: Reuters
Published April 21, 2008 04:09 PM

Data links contaminant to heparin problems

WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Monday new data shows a contaminant found in some batches of heparin is likely behind hundreds of allergic reactions and scores of deaths reported in patients given the blood thinner.

"We have data in vitro, in test tube ... as well as animal data that shows that this contaminant can trigger events that would lead to these type of reactions. That doesn't tell us everything or the whole story but it establishes a link," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told reporters by telephone.

Woodcock also said the contamination has become a worldwide issue, with tests from 10 other countries also finding a single contaminant -- over-sulfated chondroitin sulfate.

Earlier on Monday, Chinese health officials said they had concluded the contaminant was not to blame. They said they planned to visit the New Jersey plant of Baxter International Inc, which in February recalled most of its heparin products, made with ingredients from China.


(Reporting by Susan Heavey and Lisa Richwine; Editing by Tim Dobbyn)

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