April 12, 2008

Tainted products from China - Heparin

Christ on a Corn Dog -- now it's medicines... From the International Herald Tribune:
What went wrong? Heparin probe highlights challenges of regulating global drugs market
On a dusty lane in east China, a small factory sitting amid strawberry and vegetable fields processes chemicals from pig guts into heparin, a commonly used blood thinner linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany.

The mysterious problems with heparin from the factory and others like it � China's deadliest product quality scandal since Chinese cough syrup killed 93 people in Central America a year ago � dramatically illustrate the perils of shifting drug production offshore.
And the problem:
The U.S. FDA announced Tuesday it had found 62 deaths and nearly 800 severe allergic reactions associated with heparin.
And the contaminant:
The FDA says a contaminant, identified as "oversulfated chondroitin sulfate," accounted for up to half of the active ingredient in some batches of heparin from the factory, known as Changzhou SPL.
Emphasis mine -- over half of the batch is not a trivial trace contamination, this is major contamination. The Washington Post has some more:
Rise in Price Was a Sign of Trouble
Supply Problems Caused Spike That Some Say Should Have Prompted Scrutiny

The price of the Chinese-produced main ingredient used to make the blood thinner heparin doubled last year, just four months before hundreds of American patients began having severe and sometimes fatal allergic reactions to the medication, according to a report from an authoritative drug information company in China.
And it offers this little bit of information:
Chondroitin sulfate does not occur naturally but can be made from pig cartilage.
Heparin is extracted from pig intestines so this is not a simple matter of cross contamination or insufficient processing, the Chondroitin sulfate was willfully added to the raw Heparin. Sickening. Literally.

Posted by DaveH at April 12, 2008 7:30 PM
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