Heparin Problems Reported in Germany

By Steven Reinberg
HealthDay Reporter
Thursday, March 6, 2008; 8:00 PM

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THURSDAY, March 6 (HealthDay News) -- German health officials reported Thursday almost 100 cases of allergic reactions to heparin, a blood-thinning drug that has been blamed for hundreds of allergic reactions and at least four deaths in the United States.

But the German version of the drug is a different brand than the heparin supplied by Illinois-based Baxter Healthcare Corp. that has been linked to the allergic reactions in the United States, primarily among dialysis patients.

Following word of the German illnesses, the U.S. Food and Drug Administration said it was urging all U.S. suppliers of heparin to start using sophisticated screening tests to see if their products are free of a contaminant that is the leading suspect in the allergic reactions linked to Baxter's medication.

Baxter gets its main heparin ingredient, which is derived from pig intestines, from China. The heparin made by the German company, Rotexmedica, of Trittau, Germany, comes from a different supplier than the one used by Baxter. No deaths have been reported in Germany, officials said.

The adverse reactions seen in Germany occurred in a dialysis center and included severe allergic reactions and shock, U.S. health officials said.

"German authorities have identified a cluster of events in a dialysis center. They also have a cluster of similar reports from doctors," Dr. Janet Woodcock, acting director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said during a Thursday afternoon teleconference.

"The heparin active ingredient in that [German] product is not obtained from the same source as the Baxter product," Woodcock added.

It's not yet known if the active ingredient in the German heparin came from China. And it's not known if the German heparin contains the same contaminant found 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.