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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on March 06, 2008, 10:23:20 PM
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Update: Heparin Illnesses Now Reported In Germany
March 6, 2008 9:54 p.m. EST
Nidhi Sharma - AHN News Writer
Washington D.C. (AHN) - German health officials reported Thursday almost 100 cases of allergic reactions to heparin, a blood-thinning drug that was linked to 19 American deaths, U.S. officials announced Thursday. The U.S. Food and Drug Administration (FDA) is now urging all U.S. suppliers of heparin to start using some sophisticated screening tests to make sure their products are free of a contaminants.
On Wednesday, the FDA announced that tests had found a heparin-like contaminant in heparin blood-thinning products made by Chinese supplier of Baxter International Baxter. However the German version of the drug is a different brand than the heparin supplied by Illinois-based Baxter Healthcare Corp., officials added.
The main ingredient in heparin, which is derived from pig intestines, is imported from China. Dr. Janet Woodcock, acting director of the FDA's center for drug evaluation and research said they are still investigating the source of contamination but suspect it to have originated in from Scientific Protein's plant in Changzhou, China.
However, federal health officials now say 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 adding the adverse reactions occurred in a dialysis center and included severe allergic reactions and shock.
Officials are still investigating if the active ingredient in the German heparin was manufactured in 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.
Scientific Protein Laboratories on Thursday issued a prepared statement that said: " 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," it added.
In mid-January Baxter recalled nine lots of the heparin and now made a full-scale recall of its product last week. Heparin is an anticoagulant which prevents the formation of new blood clots. Heparin works quickly after administration. Since it takes a few days for anticoagulant pills (warfarin) to become effective, heparin is usually administered for about 5 days.
Bleeding complications are potential side effects of heparin therapy and may be caused by heparin interactions with platelets. However, reducing the size of the molecule (low-molecular weight heparins) and varying the dosage may reduce the risk of excessive bleeding.
http://www.allheadlinenews.com/articles/7010255413