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Thursday 27th October 2016

Chinese drug link to deaths

15th February 2008

China’s drug regulators never approved pharmaceutical production by a Chinese factory that supplies a key ingredient for a brand of blood thinner linked to four US deaths, The New York Times reports.

The factory, Changzhou SPL, wasn’t certified to produce drugs so China’s drug agency didn’t inspect it. The US Food and Drug Administration didn’t inspect the plant either - in violation of its own policy - before permitting it to become a major supplier of the blood thinner, heparin, to Baxter International in the US.

Baxter has suspended sales of its multidose vials of heparin after four patients died and 350 suffered complications. Why the heparin caused these problems and whether the active ingredient in the drug, derived from pig intestines, caused the trouble remains unknown.

The plant in Changzhou, west of Shanghai, appears to fall into the type of "regulatory void that American and Chinese health officials are trying to close," The New York Times reported, "in which chemical companies export pharmaceutical ingredients without a Chinese drug license."

US and Chinese regulators signed an agreement in 2007 under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.


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