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Part of Heparin Contaminant Mystery Solved

Posted by Jane Akre
Wednesday, March 19, 2008 12:01 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Heparin, Pet Food Recall, Wrongful Death, Medical Malpractice

Some of the questions surrounding the heparin cotnamination mystery have been solved.



IMAGE SOURCE: ©iStockphoto/ Tim Starkey

So far 19 people have died from a contaminant in the blood-thinning medication heparin while a wide net has been cast to try and identify the source that's led to a major recall of the entire U.S. supply made by Baxter International.   

FDA officials say they’ve identified the contaminant found on recalled batches of heparin - over-sulfated chondroitin sulfate.

It mimics the blood-thinning abilities of heparin and can be obtained from animal sources other than pig intestines where heparin is sourced.

It is commonly sold over-the-counter as a joint pain dietary supplement, more often known as chondroitin.

Over-sulfated indicates it was man-man as this doesn’t occur naturally, the FDA’s Dr. Janet Woodcock told reporters in a conference call. 

Was it intentionally or inadvertently added during manufacturing at the Chinese plant?  In some cases it was found in two to up to 50 percent of the recalled heparin samples.

What is still unknown is whether this is what led to 19 deaths, breathing problems and more than 700 reports of allergic reactions.

Earlier this month, the FDA said it discovered a “heparin-like” contaminant in some of heparin’s active ingredient supplied by a Chinese plant in Changzhou owned by Wisconsin-based Scientific Protein Labs.

The retired founder of Scientific Protein Labs, Dr. Jack Trautman, told IB News, that in the 1980’s he decided against setting up a similar operation that SPL co-owns today in China.

“I came away shaking my head. I find it extremely difficult to have quality control half way around the world,” he said about observing how raw material (pig intestines) was obtained from local mom and pop operations.

Heparin is widely used in clinics, for kidney dialysis, in emergency rooms and during surgery to prevent blood clots.

Competitor AAP Pharmaceuticals Inc. has stepped in to supply medical facilities. It makes about half of the U.S. supply of heparin and has so far been cleared on contaminants.

 Meanwhile, Germany has recalled heparin made for that country by Rotexmedica after allergic reactions sickened 80 individuals.   

This wouldn’t be the first case of fraud perpetuated on Americans from Chinese products.

Last year in an effort to boost the protein components of pet food, the chemical melamine was added to the ingredients by the Chinese manufacturers.  

Two Chinese nationals as well as the U.S. company owner and chief executive were, last month, indicted in the U.S. #

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