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Heparin Recalls Spread to Europe

Mar 26, 2008 | Parker Waichman LLP

Heparin has been recalled in France, Italy and Denmark amid fears that the blood thinner may be contaminated with the same substance that US regulators found in heparin supplied by Baxter International.  Baxter heparin has been tied to over 700 adverse reactions and possibly 19 deaths in the US.

In the US, Baxter first recalled 9 lots of heparin in January, after the drug was linked to serious, and sometimes fatal reactions in some patients.  Those reported reactions to Baxter heparin included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. In February, Baxter expanded the heparin recall to include all of its heparin products, and suspended sales of its drug.  Last week, B. Braun Medical initiated its own heparin recall as a precautionary measure, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall.  

Both Baxter and B. Braun source the ingredients for their heparin from Scientific Protein Laboratories, which manufactures some of the ingredients in China. The Food & Drug Administration (FDA) has confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. However, the agency has not yet determined if the chondroitin sulfate was responsible for the deaths and reactions associated with Baxter heparin.  However, the FDA since has ordered that all heparin imports be detained at the border until they can be subjected to further testing.

While the FDA maintains that it has not yet determined if the ingredient substitution was intentional, several sources told The New York Times that it was likely not accidental. Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

There have been similar recalls of Chinese-sourced heparin in Germany and Japan in the past month, and now, more European countries are following suit.  France on Friday began recalling heparin made by Rotexmedica GmbH, the same company that made heparin which was recalled from Germany earlier this month.  The active ingredient used to make heparin is also being recalled in Italy and Denmark because it is contaminated. The chemical was made by an Italian company, Opocrin SpA, which used raw ingredients sourced in China.  So far, only Germany has seen adverse reactions to heparin in patients, but a spokesperson for the European Medicines Agency said regulators there presume the contaminant found in European heparin is the same as the one identified in recalled US heparin.

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