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-Short Attention Span Theater-
Heparin Contaminant Identified
2008-03-19
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 Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.

The contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally
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.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."
And how it got sulfated. I'd have to do some digging but I'm wondering if oversulfated CS has a molecular weight similar to heparin, and whether it cross-reacts with a heparin recognizing antibody. Both would be ways to use the agent to mimic heparin in routine quality control testing.
The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."

Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. She said more exacting tests by the government and university researchers uncovered the contaminant.

FDA said Chinese officials have been highly cooperative in the investigation
Oversulfated condroitin sulfate would be less expensive to make than heparin, but FDA officials said they could not estimate the cost difference.

The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.

FDA said Chinese officials have been highly cooperative in the investigation. The investigation comes just a year after melamine was identified as a contaminate in pet food from China. Officials said an agreement signed at that time with China helped smooth the way for this investigation.

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.

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.
Posted by:lotp

#3  If it were rat poison (coumadin - a blood thinner), it's likely less people would have died.
Posted by: ed   2008-03-19 13:56  

#2  So it wasn't rat poison? Should I heave a sigh of relief?
Posted by: trailing wife   2008-03-19 13:18  

#1  The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.

Hey! I think I've found the problem...
Posted by: tu3031   2008-03-19 12:19  

00:00