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US FDA names contaminant in Baxter's heparin

Wed Mar 19, 2008 11:27am EDT

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WASHINGTON, March 19 (Reuters) - U.S. regulators said on Wednesday they had identified a contaminant found in batches of Baxter International's (BAX.N) recalled blood-thinner heparin as part of their investigation into serious reactions and deaths.

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The substance is over-sulfated chondroitin sulfate, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told reporters. Chondroitin sulfate is widely sold as a dietary supplement to treat joint pain. The over-sulfated version is not known to occur in nature and therefore likely was chemically modified, Woodcock said.

Investigators are still probing whether the contaminant caused the serious reactions reported with Baxter's heparin, Woodcock said. (Reporting by Lisa Richwine, editing by Dave Zimmerman)



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