Report: Heparin Issue Moves to Germany

By Anna Boyd
10:59, March 7th 2008
79 votes
Vote this story
Report: Heparin Issue Moves to Germany

The U.S. Food and Drug Administration said Thursday that it had received a report from German health authorities involving about 100 cases of allergic reactions possibly linked to heparin sold by a German company. No fatalities were reported though.

This is a strange thing since the heparin made by the German company, Rotexmedica, of Trittau, Germany, comes from a different supplier than the one used by Baxter, which came from Scientific Protein Laboratories, in Changzhou, China.

Following the German report, the FDA urged all U.S. suppliers of heparin to start using sophisticated tests to see if their products are free of a contaminant that is leading suspect in the allergic reactions linked to Baxter’s medication.

"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," Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research said Wednesday. In addition, this contaminant seems impossible to be detected with standard drug-quality tests because it mimics heparin.

Heparin, made from ingredients extracted from pig intestines, is used to prevent blood clots in millions of people with heart conditions, kidney disease and in surgery. The adverse reactions seen in Germany happened 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. The heparin active ingredient in that [German] product is not obtained from the same source as the Baxter product,” Dr. Woodcock said during a Thursday afternoon conference, according to Forbes.

Following the German report, Scientific Protein Laboratories issued a statement Thursday saying the German situation “demonstrates that the heparin problem is not within Changzhou SPL’s or Baxter’s manufacturing facilities, but our investigation onto the root cause of the problem will continue.”

On Wednesday, Dr. Woodcock said that a possibly counterfeit ingredient had been found in certain batches of heparin linked to at least 19 deaths in the U.S. and more than 700 severe allergic reactions since the end of December.

Last month, Baxter recalled nine lots of the heparin after receiving hundreds of reports of allergic reactions possibly linked to heparin, as well as reports of four deaths. Last month, the company recalled all remaining heparin products

 



© 2007 - 2009 - eFluxMedia
dotclear

Other News in

dotclear
Latest videos in Health
Red wine 'could cause cancer'
Celebs strut for heart health
Pope Talks to Pelosi on...
Cuba's doctors set the...
All Peanut Items Recalled...

dotclear
Health You are here: Health
» Science   » Health   
E-mail To A Friend Print RSS Text size: Decrease font size Increase font size
dotclear
dotclear
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear