China Says Contaminant Didn't Cause Heparin Reactions

-Bloomberg

04/21/2008 -- A contaminant in the blood-thinner heparin that was identified last month by U.S. regulators wasn't responsible for causing allergic reactions and deaths, a Chinese regulator said.

The contaminant, called over-sulfated chondroitin sulfate, wasn't the ``root cause'' of side effects suffered in the U.S., said Jin Shaohong, deputy director general of the Chinese National Institute for the Control of Pharmaceutical and Biological Products. The cause remains under investigation, he said today during a news conference at the Chinese Embassy in Washington.

Some samples of Baxter International Inc.'s heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated with the cheaper substance derived from animal cartilage, Baxter and the U.S. Food and Drug Administration said last month. The FDA has said it was examining whether the contaminant was responsible for the reactions.

Sixty-two people given heparin died since January 2007 after suffering allergic reactions, according to the FDA.

Deerfield, Illinois-based Baxter, which sold about half the heparin in the U.S., announced a recall in January of this year. Heparin's uses include preventing blood clots during dialysis and heart surgery.

U.S. regulators suspect heparin was intentionally contaminated to increase profit, FDA Commissioner Andrew von Eschenbach told lawmakers at an April 15 hearing. He later told reporters that the agency had no evidence the contamination was intentional.

Baxter has said the contamination appears to have happened before the product reached the company's supplier. The FDA hasn't concluded where in the supply chain the tainted material was introduced.

Recalls or warnings about heparin also have been issued in Australia, Switzerland, Germany, Italy, Denmark and Japan.

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