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FDA Approved Wrong China Firm

Hundreds ill, 4 dead after using heparin from factory never inspected

By Peter Fearon, Newser Staff

Posted Feb 19, 2008 6:26 AM CST

(Newser) – The Chinese facility that supplied the active ingredient of the blood-thinner heparin, linked to hundreds of adverse reactions and four US deaths, was never inspected by the FDA because the agency confused it with another plant of the same name, the Washington Post reports. The... Read full story »

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China • FDA • blood pressure • Government Accountability Office • inspection • House Energy and Commerce Committee • John Dingell • pharmaceutical industry • Heparin • Baxter International • blood thinner • Changzhou • Joseph Famulare • drug manufacturer • Andrew von Eschenbach

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FDA Finds Contaminant in Blood Thinner

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(NEWSER) - The FDA has found a contaminant in samples of heparin, a blood thinner produced mainly in China linked to 19 deaths and nearly 800 allergic reactions in the US, the New York Times reports. The contaminant may be a counterfeit form of heparin added to reduce its manufacturing cost. The FDA is fine-tuning tests to better detect it. More»

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(NEWSER) - The Food and Drug Administration has identified the extra ingredient found in samples of Baxter’s blood-thinning drug heparin, the Wall Street Journal reports today. Some batches of the drug—recalled in January after reports of allergic reactions—contained over-sulfated chondroitin sulfate, but it is not certain that was the cause of the hundreds of reactions or 19 deaths linked to Baxter’s product. More»

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(NEWSER) - Heparin blood thinners may have sickened as many as 100 people in Germany, health officials report. The FDA is currently investigating the drug after it was linked to 19 deaths and hundreds of allergic reactions in the US, possibly due to contaminants from China. The agency is now recommending that all American heparin manufacturers test supplies for contaminants and counterfeit ingredients. More»

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(NEWSER) - With at least four US patients dead and hundreds suffering complications from the blood-thinning drug heparin, the New York Times follows the supply chain back to Chinese slaughterhouses that deal with the pig intestines that provide raw material for the drug. Though companies say the chain is secure, the Times finds it vulnerable to contamination and lack of oversight. More»

Deadly Heparin Found in 11 Nations

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(NEWSER) - The FDA has traced a contaminated blood thinner from a Chinese factory to 11 countries, the New York Times reports. Severe reactions to the contaminated heparin have been linked to the deaths of 81 Americans, but it wasn't immediately clear if the drug may have triggered fatalities in other countries. Chinese officials have denied that the contamination caused any deaths and have demanded to be allowed to inspect the US plant where the heparin was packaged. More»

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FDA Approved Wrong China Firm

Hundreds ill, 4 dead after using heparin from factory never inspected

Made in China

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More Newser Stories

FDA Finds Contaminant in Blood Thinner

Substance discovered in heparin, linked to 19 deaths nationwide

Feds ID Extra Drug in Baxter's Recalled Heparin

FDA unsure if chemical was behind reactions to blood-thinner

Blood Thinner Woes Hit Germany

100 may have been sickened by heparin not tied to Baxter

Heparin Supply Chain Shaky in China

Troubles could trace back to vulnerable raw materials

Deadly Heparin Found in 11 Nations

FDA traces tainted Chinese blood thinner that killed 81

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