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FDA asks heparin makers to test APIs for contaminants, including BSE

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Citing patient deaths from contaminated heparin from China, the FDA has released recommendations that manufacturers test crude heparin to make sure the ingredient comes only from pig intestines.

The draft guidance also says manufacturers of the widely used blood clot prevention drug should audit their suppliers.

In early 2008, the FDA received reports of serious reactions, including deaths, from patients receiving dialysis. An FDA probe found oversulfated chondroitin sulfate (OSCS) in batches of heparin from Baxter International ($BAX), a major supplier to the U.S. market, and determined the contaminant was in ingredients from China. The episode led to congressional hearings over the level of inspections of foreign facilities. A House committee just last summer contacted nearly a dozen pharmaceutical companies about their knowledge of the incident.

The guidance document says suppliers use OSCS to save costs and manufacturers should test for it.

"OSCS contamination of heparin appears to be an example of intentional adulteration, and has also been referred to as economically motivated adulteration--i.e., heparin appeared to be intentionally contaminated with OSCS to reduce the cost of production," the agency said in its document.

But the FDA document warns of contamination dangers beyond those posed by OSCS. It says "the complexity and global nature of the heparin supply chain provide other opportunities for intentional adulteration." In particular, the reports says, is the chance for the substitution of non-porcine sources of crude heparin derived from ruminant materials that could be contaminated with the bovine spongiform encephalopathy (BSE).

BSE is also known as mad cow disease. In the 1990s, several people who ate beef in England became ill with a variant of BSE, leading to the destruction of thousands of heads of cattle and laws banning the use of ruminants in cattle feed.

The FDA will solicit comments on the document for 60 days.

- here's the Reuters story
- get the FDA guidance (.pdf)

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