Thursday, April 17, 2008

FDA suspects heparin contamination due to fraud

The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.

Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.

FDA Commissioner Andrew von Eschenbach told the US Senate on Tuesday that the agency suspected the ingredient switch had been made "by virtue of economic fraud," but added that it would leave further investigation of the matter to Chinese State Food and Drug Administration officials.

link to full article

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