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China assists US with heparin probe

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China’s drug regulator has said it is working with its US counterpart to investigate sourcing of the blood-thinner heparin, which has been linked to 19 deaths in the USA.

The US Food and Drug Administration (FDA) has expanded its probe into the hundreds of adverse reactions, including difficulty breathing, nausea and falling blood pressure, linked to Baxter International’s heparin injections.

Heparin is derived from pig intestines, and China is the world’s leading supplier of the substance.

Wu Zhen, deputy commissioner of China’s State Food and Drug Administration, said US and Chinese officials were investigating a host of heparin samples, but so far had not reached any definitive conclusions.

He said: “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.

“The most important thing now is that the scientists of both sides launch an in-depth investigation into the details.

“We can’t take effective measures until we find the cause.”

Copyright � PA Business 2008

http://www.fda.gov






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