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FDA Identifies Contaminant in Heparin

After batches of the popular blood thinner Heparin were found to be associated with the deaths of 19 individuals, an investigation by the Food and Drug Administration (FDA) has identified the unnatural chemical oversulfated condroitin sulfate as a contaminant in those particular lots of the drug. How the chemical got there and whether or not it can be linked to the deaths and other side effects are still under investigation.

The lots of heparin linked to hundreds of allergic reactions (See this Jan. 29 post)were marketed by Baxter International and produced in China, and were recalled Feb. 28 with no reported deaths since the recall. Chinese officials have been highly cooperative in the investigation and the FDA has begun testing heparin imported into the United States.

German officials have recalled another brand of heparin after 80 resports of sickness, and is in the process of narrowing down the source of the unidentified contamination to another Chinese supplier. According to the Associated Press Article, heparin comes from pig intestines, of which China is the leading supplier.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the FDA "cannot rule in or out whether this was accidentally or deliberately introduced into the product."

Have you or someone you know been victim to ill effects or injury from a drug or other product? Contact a Product Liability Attorney to dicuss your legal options.

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