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WEDNESDAY, March 5 (HealthDay News) -- Tests have found a heparin-like contaminant in heparin blood-thinning products made by Baxter Healthcare Corp. that have been linked to hundreds of adverse reactions and at least four deaths in the United States, federal health officials said Wednesday.
"While the FDA has not determined the root cause of the adverse events, we have found a heparin-like compound, which is not heparin, present in some of the active pharmaceutical ingredients produced by Scientific Protein Laboratories," Dr. Janet Woodcock, acting director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said during an afternoon teleconference.
Ray Godlewski, vice president of quality for Baxter's medication delivery business, said during a subsequent teleconference that "all the contaminated heparin came from China."
Scientific Protein Laboratories, of Waunakee, Wisc., and its Changzhou SPL plant in Changzhou City, China, is Baxter's main supplier of the active pharmaceutical ingredient in heparin, Woodcock said.
"This contaminant is present in significant quantities in some of the active pharmaceutical ingredients, accounting for approximately 5 to 20 percent of the substance tested," Woodcock said.
The substance reacts like heparin in the conventional tests that are used for heparin, which is why those tests of ingredients might not detect the contaminant, Woodcock said.
Heparin is a blood-thinner whose main ingredient comes from pig intestines. The drug is often given to dialysis patients and people undergoing heart surgery.
"At this point, we do not know how the heparin-like compound got into a heparin active pharmaceutical ingredient," Woodcock said. "Whether it was deliberately or accidentally added it is not known," she added.
The tests that found the contaminant were conducted by the FDA and Baxter, as well as some university laboratories.
Woodcock said the FDA hasn't uncovered a direct link between the contaminant and the adverse events and deaths. "We know that some of the suspect batches of heparin that were causing the adverse events have this contaminant in it. So there is an association between the contaminant in the presence of adverse events, but it is not a direct causal link yet," she said.
