Heparin Concerns Grow

This Tuesday federal regulators from the FDA urged makers of many kinds of medical devices that contain heparin to test their supplies. These concerns arise from previously discovered supplies of Chinese made heparin contaminated with a look-alike ingredient that mimicked heparin in standard tests of drug potency and purity.
The FDA announced last month that it had identified the contaminant as a modified form of a common nutritional supplement. That substance is cheaper to produce than heparin, leading to suspicions that it may have been intentionally added somewhere along a complex and lightly regulated supply chain in China.
China is the world’s leading supplier of heparin, a blood thinner often made from a substance in the intestines of pigs. It is commonly given to prevent blood clots in heart surgery and dialysis patients
The products to be tested cover a spectrum of equipment and uses. They include kits that flush out intravenous lines, drug-coated stents for opening clogged arteries and certain diagnostic tests that use heparin and could deliver inaccurate results if contaminated.
Separately, the FDA released statistics on deaths linked to intravenous heparin, the form of the drug in which problems were first detected. The numbers showed an increase in fatalities from November 2007 through February 2008, with problems rapidly abating last month after Baxter Healthcare Corp. issued a recall.