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Last Updated: Apr 20, 2011 - 9:38:09 AM |
SATURDAY March 15, 2008 (Foodconsumer.org) -- Heparin manufactured by Baxter International has been linked with 21 deaths, news media reported. Most of the deaths have not been proved to be associated with use of Baxter’s heparin, according to the manufacturer. It's been suspected that an impurity or contaminant may cause the deaths and more than 780 allergic reactions. News media vented lots of emotion on the Chinese factory that supplies a key raw ingredient to Baxter for the manufacturing of its heparin. Chicago Tribune has already published an editorial to say "the quest for lower prices can have lethal side effects".
The Chinese factory is unlikely to take the blame. Officials of the supply company in Wisconsin, the partner of the Chinese company, said early that evidence did not suggest the processor conducted any wrongdoing. Baxter was cited by the Los Angeles Times as saying Friday that investigators now suspect that the raw material used to make the blood thinner might have been contaminated even before it reached the Chinese factory.
The Chinese factory is not 100% Chinese. In fact, according to media reports, it is a joint-venture partner with Baxter's supplier, Wisconsin-based Scientific Protein Laboratories. So far, no one including the Food and Drug Administration could have blamed it for anything. The likely problem if there is any may lie with the raw material collected by so-called consolidators or middlemen from small family-run enterprises, which are at the low end of the supply chain.
Heparin is a naturally occurring substance and isolated from the intestines of pig. It is commonly used to prevent the blood from clotting in patients during kidney dialysis and cardiac surgery among other things. The natural substance can cause some side effect, commonly known as heparin-induced thrombocytopenia (HIT syndrome). In the case of allergic reactions to Baxter’s heparin, symptoms include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock, according the New York Times.
The FDA said March 11 that a heparin-like substance was detected in a high percentage of samples at a level of 5-20%. The substance acts like heparin and is not Heparin present in some of the Heparin Active Pharmaceutical Ingredient (API) produced by Scientific Protein Labs, which maintains a facility in Wisconsin in addition to the Changzhou plant. The agency said it is not clear how this contaminant got into Heparin Active Pharmaceutical Ingredient and whether it is responsible for the severe allergic reactions associated with use of Baxter's heparin.
Government officials are still investigating the heparin problem. Meanwhile, the FDA Friday announced new testing requirements fro all imported heparin. The manufacturers from now on will have to undertake sophisticated tests or their products will be blocked at ports of entry for government testing, Los Angeles Times reported. Also FDA announced March 14 it has obtained approval from the State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in China over the next 18 months in addition to five local Chinese nationals to be hired to work with the new FDA staff at the U.S. Embassy in Beijing and The U.S. Consulates General in Shanghai and Guangzhou. In the wake of Baxter's heparin accidents, the FDA has been blamed for not inspecting the Chinese factory due to a name mix-up.
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