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Hundreds of injuries and at least 81 deaths have been linked to contaminated heparin, the Food and Drug Administration reported this week.
On Monday, FDA officials said contaminated heparin has been identified in 11 countries including the United States, France, Germany, Japan, Canada, and New Zealand, among others.
However, most of the adverse reactions have occurred in patients at hemodialysis centers across the U.S. between November 2007 and February 2008. Adverse reactions to contaminated heparin include difficulty breathing, sweating, nausea, vomiting, and shock.
Made in China
Heparin is a widely-used blood thinner manufactured primarily in China. The contaminant has been identified as a chemical known as oversulfated condroitin sulfate, and contaminated heparin has been traced to a dozen Chinese companies.
FDA officials say the contamination occurred at some point in the supply chain, though they emphasize they are still unsure of the exact origin.
“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,” said Dr. Janet Woodcock of the FDA.
(Source: HealthDay News)
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