The U.S. Food and Drug Administration (FDA) said that 81 deaths have now been linked to contaminated Heparin. Eleven countries have been affected as the FDA continues to investigate the source of the contamination.

The latest on Heparin

The FDA has increased the number of Heparin related deaths since the beginning of 2008 from 61 to 81 and continues to investigate the source of the problem. Heparin, whose raw ingredient is derived from pig intestines and is used to prevent blood clots in cardiac procedures, mainly comes from China. At this point, 11 countries have been affected by the contaminated Heparin and experts say that other countries may also be affected, but don’t know it yet. The 11 countries are Australia, Canada, China, Denmark, France, Germany, Italy, Japan, The Netherlands, New Zealand and the United States.

According to the FDA, the contamination seems to come from use oversulfated chondroitin sulfate – a compound made from animal cartilage that is less expensive to produce. The Administration has alleged that economic fraud may be involved.

FDA points fingers at China

The FDA is pointing its fingers directly at China and issued a warning letter to Wisconsin-based Scientific Protein Laboratories that owns a factory in Changzhou, China where much of the contaminated heparin seems to have originated.

The letter, dated April 21, 2008 and posted on the FDA’s website, www.fda.gov/, lists the following specific areas of non-conformity to required standards:

• There is no assurance that processing steps used to manufacture heparin sodium USP are capable of effectively removing impurities.
• You fail to have adequate systems for evaluating the suppliers of heparin crude materials, and the crude materials themselves, to ensure that these materials are acceptable for use.
• The test methods performed for heparin sodium USP have not been verified to ensure suitability under actual conditions of use.
• Equipment used to manufacture heparin sodium USP is unsuitable for its intended use.

The FDA continues to investigate the source of contamination.

What to do if you’ve received Heparin

If you’ve received Heparin, contact an attorney who has been following the Heparin recalls and whose practice focuses in this area of the law. To contact a qualified attorney to discuss your situation confidentially, please click here. The consultation is free and without obligation.