China detects suspect ingredent in heparin samples
Updated: 2008-03-20 07:29
BEIJING - China has detected an ingredient basically the same as the US has found from the heparin products exported to the latter, the State Food and Drug Administration (SFDA) said Wednesday.
The ingredient, called Hypersulfated Chondroitin Sulfate, was detected in accordance with the test method provided by the US side, said a spokesman with the Chinese drug watchdog.
The administration, however, like the US side, was not certain whether the ingredient was to blame for the adverse reactions that heparin products had caused in the United States, said the spokesman.
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It is reported that heparin blood-thinner products, with a suspiciously contaminated ingredient from a supplier in Changzhou, east China's Jiangsu Province, have caused serious reactions and deaths in the United States.
Since the relevance of the ingredient to the allergic reactions was not immediately determinable, the SFDA was organizing experts for further investigations, and the result would be made known to the public, the spokesman said.
The administration has not received reports of similar large-scale adverse reactions in China, and has ordered drug supervision departments all over the country to closely monitor the situation.
The Changzhou Kaipu Biochemical Co. is one link in a long production chain of heparin, according to the administration. The factory's share-holder, Scientific Protein Laboratories (SPL), imports the raw heparin from the Chinese factory and supplies it to Baxter International, one of the major heparin producers in the United States.
The Changzhou factory, a chemical plant but not a drugmaker, is not registered within the SFDA and its raw heparin is subjected to quality checks both by itself and SPL, the administration said.
It is reported earlier that FDA detected suspicious contaminant in raw heparin from the Changzhou factory by using "non-standard" drug-purity test, but FDA is not certain that the contaminant is to blame for the allergic reactions.
China now has 23 registered raw heparin suppliers, with some sheer for exports.
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