Italy, France, Denmark & Australia Recall Heparin

Article: Italy, France, Denmark & Australia Recall Heparin

Italy, France, Denmark and Australia have recalled Heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures. These countries join the United States, Germany, Canada and three Japanese companies who have already recalled the drug which has reportedly caused 700 injuries and 19 deaths.

The controversy

Raw Heparin, which is derived from pig intestines, is generally obtained from factories in China. In the United States, Baxter International and B. Braun Medical obtain their raw Heparin from Scientific Protein Laboratories who own factories in China. France and Germany reportedly obtain their raw Heparin from the company Rotexmedica GmbH. Italy and Denmark reportedly obtain their raw Heparin from the Italian company Opocrin SpA. Canada and Australia reportedly receive their raw Heparin from B. Braun Medical. All of the raw Heparin originates in China, which until last week, barely regulated the industry.

FDA confirms contaminant

The U.S. Food and Drug Administration (FDA) confirmed that it has found chondroitin sulfate (a protein molecule) in samples of the active ingredient used in Baxter’s Heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties and thereby contaminated the product. While the FDA hasn’t stated that the injuries and deaths surrounding the contamination are conclusively from the product, it has ordered all Heparin imports to be detained at the U.S. border until they can be adequately tested.

Can the source of Heparin be traced?

Douglass Kreis, a Florida attorney whose firm protects the rights of consumers who are seriously injured due to defective drugs such as Heparin, explained the problems associated with tracing raw Heparin. Kreis says that there seem to be two groups of thought, “The first is that we need to go back and trace, through this extraordinarily intricate distribution chain, the heparin raw product back to the actual pigs and try to find the livestock that’s sick and producing this tainted heparin.”

“The second is that it is not realistic to think that we’re going to be able to go into villages and try to figure this out. There’s a lack of paperwork and regulation, so we need to put a stop to the importation of any heparin from China without there being a prophylactic at our border. The FDA is extraordinarily under funded and under subsidized, so the drug manufacturers have to bear that burden. But, it’s an additional cost and they’re not just going to pay it without a fight.”

If you’ve been injured due to heparin use, contact an attorney to discuss your situation. The consultation is free and without obligation. To contact a qualified attorney whose practice focuses in this area of law, please click here.