Heparin Problems Reported in Germany (und in the Baxter heparin which is suppl...)

Heparin Problems Reported in Germany

Date:3/6/2008

und in the Baxter heparin, which is supplied by Scientific Protein Laboratories, of Waunakee, Wisc.

Following Thursday's FDA teleconference, Scientific Protein Laboratories issued a prepared statement that said: "In a press briefing today, the FDA announced that the German health authorities have recalled heparin that has been associated with similar adverse event clusters as have been reported in the United States. This heparin was sourced from an API [active pharmaceutical ingredient] company other than SPL. We believe this demonstrates that the heparin problem is not within Changzhou SPL's or Baxter's manufacturing facilities, but our investigation into the root cause of the problem will continue.

On Wednesday, the FDA announced that tests had found a heparin-like contaminant in heparin blood-thinning products made by Baxter.

"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," Woodcock said during a Wednesday teleconference.

Ray Godlewski, vice president of quality for Baxter's medication delivery business, said "all the contaminated heparin came from China."

Scientific Protein Laboratories 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 Wednesday.

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 often given to dialysis patients and people undergoing heart surge
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