Friday, February 15, 2008

Problem Drug Made in China

Baxter International Inc.'s investigation into the cause of deaths and allergic reactions linked to its blood-thinner heparin is focusing on variations in batches of the active ingredient for the drug, most of which were supplied by a Chinese manufacturing facility co-owned by a Wisconsin company.

Baxter said the active ingredient for its heparin was supplied by Scientific Protein Laboratories LLC, a Waunakee, Wis., company with a manufacturing facility there and a joint-venture operation called Changzhou SPL in Changzhou, China. Baxter declined to elaborate on the nature of the variations, but heparin is a particularly tricky product to manufacture because it is derived from pig intestines.

On Monday, Baxter said it had temporarily stopped production of heparin because of about 350 bad reactions, including four fatalities, potentially tied to the drug, which is used primarily in kidney dialysis and heart surgery. An FDA official estimated that about 40% of the adverse reactions among patients taking the Baxter drug were classified as serious. They ranged from stomach pain to vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.

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