Monday, June 09, 2008

FDA: 11 Deaths In Medical Devices Tied To Heparin

Unfortunately, we are now moving on to medical devices...

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has received reports of 11 deaths and other adverse events associated with medical devices that contain heparin, a widely used blood thinner that has sparked Congressional inquiries about the agency's oversight of drug manufacturing.

The FDA, in documents posted on its Web site Thursday, said it can't determine at this time whether the devices cited in the reports contain contaminated heparin.

Most of deaths were reported by families. As a result, FDA spokeswoman Karen Riley said, the agency in many cases can't identify the manufacturer or from which lots the heparin came. The FDA is working to contact the families to try to find more information.

Riley said the FDA was able to trace back two of the death reports to conclude that the heparin wasn't contaminated in those cases.

Contaminated heparin from China had previously been linked to 81 deaths in the U.S. and hundreds of allergic reactions. Baxter International Inc. (BAX) is the largest supplier of heparin.

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