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FDA: Contaminated Heparin Found in 10 Countries
Date:4/21/2008

And 'biological mechanism' that leads to adverse reactions identified, officials add

MONDAY, April 21 (HealthDay News) -- Contaminated heparin products have now been found in at least nine countries, not including the United States, leading to ongoing surveillance measures to ensure the safety of the blood thinner, U.S. health officials announced Monday.

In addition, officials said contaminated lots of the blood thinner have been traced to 12 different Chinese companies that were somehow involved in heparin manufacture. Officials believe a man-made chemical called oversulfated condroitin sulfate -- or OSCS -- may be responsible for dozens of deaths and hundreds of adverse reactions in the United States associated with contaminated heparin between roughly last November and February. The heparin was marketed by Baxter International Inc., of Deerfield, Ill.

"We do not know where the contamination occurred but we do know ... of at least 12 Chinese firms that are in the supply chain for contaminated heparin," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said at a news conference.

According to the FDA, contaminated heparin has now been linked to as many as 81 deaths and hundreds of injuries in United States, and well as some incidents in Germany.

Woodcock also announced that the FDA has identified a likely "biological mechanism" by which the oversulfated condroitin sulfate leads to the adverse reactions observed. Those reactions include difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, and life-threatening shock.

Woodcock's announcement seemed to conflict with statements made earlier Monday by Chinese officials who said that oversulfated condroitin sulfate was not responsible for the reported injuries and deaths.

"We are aware that our Chinese colleagues are skeptical that such a link has been established. We are
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