Use of Heparin Concerns the Food and Drug Administration

Drew Dixon

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    The Food and Drug Administration recently asked the makers of many kinds of medical devices that contain the drug Heparin to test their supplies.  The concerns came after a number of serious allergic reactions were linked to medical devices which contained Heparin.      

    The FDA's statistics showed 62 deaths associated with the severe reaction in the 15 months from January 2007 through last month -- an increase from the agency's previous count.  Of these reported deaths, 47 came in the four-month period from November, 2007 to February, 2008.

    China is the world's leading supplier of heparin, a blood thinner often made from a substance in the intestines of pigs.  The FDA has identified the contaminant as a modified form of a common nutritional supplement.  That substance is cheaper to produce than Heparin; leading to suspicions that it may have been intentionally added somewhere along a complex and lightly regulated supply chain in China.

    Heparin acts as an anticoagulant, preventing the formation of clots and extension of existing clots within the blood.  While heparin does not break down clots that have already formed, it allows the body's natural clot lysis mechanisms to work normally to break down clots that have already formed.  Heparin is most commonly used for anticoagulation for the following conditions:

·         Acute coronary syndrome, e.g. Myocardial infarction

·         Atrial fibrillation

·         Deep-vein thrombosis and pulmonary embolism

·         Cardiopulmonary bypass for heart surgery

For More Information Please Visit the Food and Drug Administration Website www.fda.gov.