As a result, FDA to require testing of all imported heparin
FRIDAY, March 14 (HealthDay News) -- The contaminant found in the blood-thinner heparin, which has been linked to hundreds of allergic reactions and possibly 19 deaths in the United States, has been traced to a Chinese plant that processed raw ingredients for the drug, U.S. health officials said Friday.
As a result, the U.S. Food and Drug Administration said it will start testing all heparin products to be imported into the United States. The announcement comes as the agency continues its investigation into the contamination with heparin produced by Baxter Healthcare Corp., of Deerfield, Ill.
The heparin was supplied to Baxter by Scientific Protein Laboratories of Waunakee, Wisc., and its Changzhou SPL plant in Changzhou City, China. The company is Baxter's main supplier of the active pharmaceutical ingredient in heparin.
"The active pharmaceutical ingredient comes from the Changzhou SPL plant in China," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said during an afternoon teleconference.
"The FDA conducted an inspection in this plant, and we obtained 28 samples of the active pharmaceutical ingredient," Woodcock said. "We found 20 of these samples had a heparin-like contaminant."
In light of the finding, the FDA has placed the Changzhou SPL plant on "import alert," Woodcock said, meaning the plant has agreed not to export any more heparin to the United States.
In a statement released late Friday, Baxter said its staffers "have been working seven days a week since late December 2007" trying to determine the nature of the contaminant. The company has so far ruled out a number of infectious pathogens, dioxins or the pufferfish toxin (tetrodoxin).
"While Baxter's analysis is not complete, the company has evidence that the unknown material is a highly sulfated glucosaminoglyca
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