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Three Years Later, Tainted Heparin Saga Continues

Oct 27, 2011 | Parker Waichman LLP

Tainted heparin could still be a threat, according to a group of Republican lawmakers, because two Chinese companies that sold counterfeit ingredients to Baxter International continue to import product to the U.S.  Representative Fred Upton of Michigan, chairman of the House Energy and Commerce Committee, and his Republican colleagues have written to the Food & Drug Administration (FDA) asking why U.S. drugmakers haven't been warned to avoid the two unnamed firms.

In 2008, 81 U.S. deaths were tied to contaminated heparin.  Baxter International recalled all of its heparin injections in January of that year, while the FDA ultimately issued 13 separate recalls of products that contained heparin.  It was eventually determined that heparin had been contaminated with oversulfated chondroitin sulfate that was molecularly changed to mimic heparin's blood-clotting properties in samples of the active ingredient used in Baxter heparin. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Now it seems that the two unidentified Chinese firms that sold the tainted ingredients to Baxter's supplier, Changzhou SPL, are still importing products to the U.S.

“We have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States,” the lawmakers wrote Hamburg. “We have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms.”

A statement issued by the Committee also voices concern that tainted heparin could still pose a risk to the 12 million U.S. patients treated with the drug every year. 

The Committee reopened its heparin investigation in February.

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