FDA: Tainted heparin still out there

-Renal Business Today

06/11/2008 - Injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS) were found in medical care facilities in one state since the heparin recall, according to the U.S. Food and Drug Administration.

“Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used,” according to an FDA press release.

The blood-thinning drug heparin is often used in dialysis treatments and is derived from pig intestines, which are mostly supplied from China. Baxter had to recall its supply of heparin after hundreds of adverse reactions were reported across the United States, and a contaminant was found in the supply chain from China.

The contaminate—which may have caused up to 81 deaths—has been found in 11 countries and has been linked to 12 Chinese sources, according to the FDA.

FDA said health professionals and facilities should review and examine all drug/device storage areas—including emergency kits, dialysis units and automated drug storage cabinets—to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.

In addition, FDA warned health professionals about other types of medical devices that contain, or are coated with, heparin.

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