Heparin in Medical Devices Linked to 11 U.S. Deaths

-Bloomberg

06/05/2008 - Eleven deaths and 86 cases of harmful side effects have been linked to use of medical devices containing the blood thinner heparin, U.S. regulators said.

The side effects and deaths occurred between Jan. 1 and May 14, the Food and Drug Administration said today on its Web site. The FDA has not determined conclusively that recalled heparin made by Baxter International Inc., some of which included a contaminant from China, was the cause.

Baxter voluntarily recalled heparin, used to prevent blood clots, beginning in January after reports of side effects. Regulators have warned doctors and patients not to use the recalled heparin, some of which is in medical devices such as heparin-coated oxygenators.

The FDA said contamination also could lead to inaccurate test results from diagnostic devices that monitor heparin or use it as part of the device itself, according to the agency Web site.

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