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China's drug safety agency says no link proven yet in contaminated heparin cases

AP - Wednesday, May 7

BEIJING - China's drug safety agency said Tuesday no direct link had been proven between deaths in the United States of people using a blood thinner and a substance in the drug.

The statement from the State Food and Drug Administration comes after a U.S. congressional subcommittee was told last month that contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions.

The heparin, made from ingredients imported from China, has been recalled by Baxter International and the U.S. Food and Drug Administration has blocked further imports from the Chinese company.

The FDA found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing, said Rep. Bart Stupak of Michigan, chairman of the House Energy and Commerce subcommittee on oversight and investigations.

"Chinese experts believe that the direct cause for heparin issues that occurred in the United States and other countries cannot yet be ultimately identified as the heparin-like substance (oversulfated chondroitin sulfate)," the Chinese statement said.

"Apart from the United States and Germany, more than 10 other countries using heparin products containing heparin-like substances have not reported any cases of adverse reactions," it said.

The allegations come as China has been struggling to improve the safety of its exports after widespread allegations that many of its products _ from toys to fish _ are shoddy or dangerous.

Raw heparin is derived from pig intestines, often processed by small, unregistered workshops in China. The raw ingredient for Baxter's recalled heparin came from Wisconsin-based Scientific Protein Laboratories, which in turn owns a Chinese factory _ Changzhou SPL _ and buys additional raw heparin from other Chinese suppliers.

Last month, the U.S. Food and Drug Administration warned Changzhou SPL the company does not have adequate systems for ensuring the raw materials it uses are safe and that any impurities are removed. The FDA noted as many as 12 companies in China are involved in the supply chain for heparin.

Agency officials don't know at what point the contaminant was introduced.

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