The U.S. Food and Drug Administration (FDA) has halted all imported heparin into the United States and will not authorize distribution until it inspects and/or tests it. The move is in response to an increasing number of adverse reactions in the U.S. and other countries who obtain raw heparin from China.

FDA action

The FDA announced that five companies have agreed to have their raw heparin detained at their points of entry into the United States to test for contamination. Although the names of the companies have not been divulged, news reports have stated that Baxter and APP Pharmaceuticals, the two largest manufacturers and importers of heparin, have agreed to inspection and testing.

Too many reported injuries and deaths

The FDA has received nearly 800 reports of adverse reactions to heparin and 20 deaths – far too many according to consumer advocates. The drug, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures, has been the source of controversy for months. Raw heparin is made from pig intestines from China – often in facilities with unsanitary conditions. The problem is not limited to the U.S. either. Germany and Japan have also taken measures to contain or monitor raw heparin obtained from China.

Is help on the way?

The Chinese government does not regulate the factories that produce raw heparin and the FDA and U.S. manufacturers haven’t done much more. According to attorney Douglass Kreis, whose firm protects the rights of consumers who are seriously injured due to defective drugs such as heparin, stated that “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.”

As part of its Beyond Our Borders initiative, the FDA has received approval to station eight inspectors in China to monitor goods that come from that country and U.S. manufacturers have indicated that they will do more to address the issue. 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.