Portfolio Media, New York (April 22, 2008)--The U.S. Food and Drug Administration has found new evidence linking deaths and allergic reactions to a man-made contaminant that had been introduced in the blood thinner heparin during production in China.

Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, said on Monday that a contaminant in the heparin batches was traced to 12 different Chinese companies. The batches were shipped to 11 nations.

The FDA pointed to over-sulfated chondroitin sulfate as the root cause of the adverse reactions. The contaminant is of the same family as heparin, so only advanced testing was able to identify it in heparin stocks.

Tests on heparin batches from China showed that the contaminant accounted for as much as 50% of the active ingredient. Oversulfated chondroitin sulfate is not approved for use in the U.S.

The FDA said it suspected, but cannot yet prove, that the additive was put into regular heparin stock to keep costs down.

“We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions,” Woodcock said.

The agency released a warning letter to Changzhou SPL Co., the Chinese plant identified as the source of contaminated heparin made by Baxter International Ltd. in the United States.

The FDA told Changzhou SPL that it had “significant deviations” from good manufacturing processes that needed to be corrected before U.S. companies could use it as a pharmaceutical ingredient manufacturer again.

But Chinese officials said some of the batches of heparin associated with the severe allergic reactions did not have the man-made chondroitin sulfate in them. They also contended that contaminated heparin had been found in many nations, but only the U.S. had seen such a large spike in adverse reactions.

A top Chinese official, Jin Shaohong, told reporters that the Chinese government was conducting its own investigation of the heparin issue and that the contaminant could have been introduced when imported raw heparin was refined and then prepared for distribution in New Jersey.

A Baxter representative disagreed with the Chinese conclusions, arguing that the FDA's evidence was strong and all the contaminated batches of heparin contained over-sulfated chondroitin.

In early April, the FDA dramatically increased its count of people who have died while taking the blood thinner, finding that there had been 103 reports of death associated with heparin since Jan. 1, 2007, and that 91 of these incidents were reported to the agency on or after Jan. 1, 2008.

The statistics includes all reports submitted to the FDA from Jan. 1, 2007, to March 31, 2008. Previously, the FDA had only reported about 20 deaths that were linked to an administration of heparin. A total of 55 such deaths were reported in 2006.

The FDA noted that just because an adverse event is reported, it does not necessarily mean that a specific drug caused the medical event or death.

Baxter and the FDA recalled several dosage types of heparin in early February after it caused adverse reactions, including breathing difficulty, vomiting, excessive sweating and rapid decrease in blood pressure.

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