The U.S. Food and Drug Administration (FDA) has said that an unknown contaminant has been identified in batches of heparin, – a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures. However, the administration doesn’t know whether or not the contaminant is the cause of the injuries and deaths that have been associated with the drug. Germany and Japan have recalled the drug amid health concerns that the drug may cause severe injury or death.

The FDA issued the following information:

Adverse events, including deaths, have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection as well as HEP-LOCK heparin flush products.

After launching a disciplined, methodical examination, FDA scientists have identified a previously unknown contaminant in the heparin. The agency does not have proof that this contaminant is causing the adverse events. There is an association, but not a direct causal link at this time. At this point, FDA does not know how the contaminant got into the heparin active pharmaceutical ingredient (API). The agency is continuing to aggressively investigate the situation.

Limited regulation a problem for all

The limited regulation of the Chinese factories that produce heparin is a problem for everyone, according to attorney Douglass Kreis, whose firm protects the rights of consumers who are seriously injured due to defective drugs such as heparin. Kreis has been following the controversy and explained that “There is very little regulation and really no documented list of the suppliers of the raw product in China. The Chinese government has said openly that they do not inspect all of the plants from which the heparin comes from. There was a pig flu or disease that had gone around and killed a lot of the livestock in China within the last year, although there is very little information about it.”

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.