U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug. The lots of heparin were recalled in February. FDA officials reported on March 18th, that no new deaths have been reported since the recall. Dr. Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally. Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied. The FDA is investigating to see how it got into the drug.
The FDA has also initiated testing of imported heparin entering this country. Hopefully, the product on the market now has been tested and is safe. Since Condroitin sulfate with a compound is in the same family as heparin, the FDA says preliminary testing failed to identify it. Apparently, more exacting tests by the government and university researchers uncovered the contaminant. Oversulfated condroitin sulfate would be less expensive to make than heparin, but FDA officials aren’t able to estimate the cost difference. The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China. We should have learned by now that anything coming from China has to be at least suspect.
FDA officials said they could not yet directly associate the oversulfated condroitin sulfate to the deaths and side effects, but it is the lone contaminant they have found in the product. As we have reported, Heparin is derived from pig intestines, and China is the world’s leading supplier. Tiny family-run workshops near slaughterhouses send batches of raw ingredients to larger middlemen before they reach factories. Hopefully, Chinese government officials are working to improve safety of the products they are sending into the U.S. In fact, they claim to have clamped down on the production of heparin.
Source: Associated Press
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