Heparin Credit:wikipedia

MONDAY April 21, 2008 (foodconsumer.org) -- The Food and Drug Administration has early told the Chinese Manufacturer of a key heparin ingredient that it does not adequate means to ensure the ingredient is made free of impurities, The Associated Press reported today.

The FDA viewed a contaminant known as synthetic chondroitin, which is similar structurally to the heparin, as the suspected cause for the association between Baxter's heparin and hundreds of allergic reactions and 62 deaths.

All brands of Baxter's heparin of concern were made of an ingredient prepared by Changzhou SPL Co., a Chinese company solely owned by a Wisconsin company known as Scientific Protein Laboratories.   

The products have been recalled after reports emerged to suggest that its products linked to many deaths and allergic reactions.  But months after the recall, the cause of allergic reactions remains unknown.

Chinese officials today rejected the FDA's conclusion that the synthetic impurity over-sulfated chondroitin found in tainted supplies of the blood thinner heparin was the likely cause of the allergic reactions and deaths, Washington Post reported.

Jin Shaohong, a top official with the Chinese National institute for the Control of Pharmaceutical and Biological Products, claimed that the impurity in the ingredient could not be the root cause of the adverse reactions found in patients using heparin.

Jin said some batches of heparin associated with severe allergic reactions and distributed by Baxter international did not contain the synthetic chondroitin, meaning the adverse effects could be caused by something else.  

He was also cited as saying heparin with the contaminant has been used in more than ten other nations, but none has reported harmful reactions associated with use of these products.  Jin suggested that the caustic agents could be introduced during the processing in Baxter's New Jersey facility.

Baxter spokeswoman Eric Gariner was cited by Washington Post as saying that the Chinese officials were incorrect when they said some batches of heparin that caused severe reactions did not contain the chondroitin.  And Baxter insisted that the over-sulfated chondroitin definitely appeared to be the problem.

Today the FDA released a warning letter to Changzhou SPL Co. just hours after Chinese officials disputed the FDA's notion that the impurity in heparin caused allergic reactions in hundreds of U.S. patients.  

The U.S. agency said in the letter it will recommend disapproval of any new applications listing the company as the manufacturers of any active pharmaceutical ingredient because the company had "significant deviations" from good manufacturing processes.

The operation of the Chinese company is controlled by Wsiconsin-based Scientific Protein Laboratories, which early defended the company saying there is no evidence suggesting the raw heparin ingredient has anything to do with the allergic reactions.

But the FDA Monday said new data showed the contaminant found in some batches of heparin is likely the problem.  And 10 other countries also found the single contaminant over-sulfated chondroitin sulfate in heparin.

"We have data in vitro, in test tube ... as well as animal data that shows that this contaminant can trigger events that would lead to these type of reactions. That doesn't tell us everything or the whole story but it establishes a link," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, was quoted as telling reporters by telephone.

For more information on heparin, read http://en.wikipedia.org/wiki/Heparin

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