China clamps down on production of Heparin

-Baltimore Sun

03/21/2008 -  China announced today it is clamping down on production of Heparin in the latest sign that suppliers there were to blame for contamination of the blood-thinning drug that has killed as many as 19 Americans.

The Chinese government ordered Heparin producers to get their raw materials from registered suppliers only and directed the suppliers to test their products for contamination, according to wire service reports. Chinese drug regulators also required Heparin makers and exporters to look for signs of side effects among users of their products and issue recalls if they find anything.

The moves came a day after Chinese authorities confirmed that a key Heparin ingredient shipped to the United States contained a contaminant, over-sulfated chondroitin sulfate. On Wednesday, the U.S. Food and Drug Administration identified the chemical.

Investigators are still trying to confirm that the chemical caused the hundreds of reported side effects among Heparin users. They are also probing whether the chemical was deliberately used to make a bigger profit off of the products.

After Baxter International Inc. recalled nearly all its Heparin products last month, Chinese drug regulators first resisted taking action, saying American importers and regulators were responsible for assuring the quality of shipments. Baxter got the main ingredient in suspect Heparin products from a joint venture in eastern China, which got its raw materials from suppliers there.

FDA officials have refused to place blame anywhere. Yet the scare has exacerbated already strong American fears about importing goods from China.

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