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China Official: Working With US On Probing Tainted Heparin

Mar 16, 2008 Market Outlook

China Official: Working With US On Probing Tainted Heparin

Last Update: 3/16/2008 6:53:38 AM

BEIJING (AP)–China and the U.S. are working together to investigate suspicious
ingredients for the blood-thinner heparin that have been linked to 19 American
deaths, China’s State Food and Drug Administration. said Sunday.

Both sides have investigated samples in labs, but no conclusion is yet available,
said Wu Zhen, deputy commissioner of the administration.

“China’s State Food and Drug Administration and America’s FDA are working closely
together on the Heparin investigation, and American investigators came to China
to investigate and we supported them,” he told a news conference.

“The most important thing now is that the scientists of both sides launch an
in-depth investigation into the details,” he said. “We can’t take effective
measures until we find the cause.”

The FDA is widening its investigation in the United States of hundreds of
allergic-type reactions - including difficultly breathing, nausea, and falling
blood pressure - linked to the drug developed by Baxter International.

Heparin is derived from pig intestines, and Baxter gets its supply from China,
the world’s leading maker of heparin.

The FDA found the contaminant in 20 of 28 samples of raw heparin that the agency
tested from Baxter’s main supplier, Scientific Protein Laboratories of the U.S.,
which gets the bulk of its heparin from a joint venture in China’s east Jiangsu
province.

Wu said it was still unclear at what stage the heparin had been contaminated,
because the production process was so complicated and long. As well, Scientific
Protein Laboratories got its raw material from a joint venture in Changzhou
called Kaipu Biochemical Co., also known as Changzhou SPL.

The heparin could also have been contaminated after production, or when the drug
was exported overseas, he said.

A different brand of heparin also has been recalled in Germany after 80 patients
there became sick, and the German manufacturer said that it was narrowing down
the source of contamination to another Chinese supplier.

The mayor of Changzhou, Wang Weicheng, said Friday that the city government had
cooperated with the investigation and was seriously monitoring the companies in
the city, but it was the first time a problem has been reported. The city shut
down 800 chemical companies last year for violating environmental standards, he
said.

(END) Dow Jones Newswires

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