France, Italy and Denmark Join Heparin Recall

By Anna Boyd
13:44, March 26th 2008
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France, Italy and Denmark Join Heparin Recall

France, Italy and Denmark join the U.S.’ decision to recall heparin because of concerns about contamination with Chinese-made ingredients, Europe’s drug regulator said Tuesday.

Heparin is made from ingredients taken from pig intestines that are purified for use in humans to prevent blood clots during dialysis and heart surgery.

A “small” number of batches were removed as a “precautionary measure right now,” Martin Harvey-Allchurch, a representative for the European Medicines Agency said in a telephone interview, according to Bloomberg.

The recalled products haven’t been linked to any side effects, he added. Earlier this month, Germany and Switzerland announced their decision to pull some heparin from their markets.

In the U.S., Baxter International Inc. recalled nearly all its U.S.-sold heparin injections after a number of patients experienced extreme allergic reactions. Moreover, there were reported 19 deaths caused by the drug. The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter and produced in China.

The EMA presumes the contaminant in all three countries is the same as the one identified in recalled U.S. batches of the drug, a chemical called over-sulfated chondroitin sulfate.

Harvey-Allchurch said that European patients who need heparin should not be affected and that the drug’s supply comes from different sources than in the U.S. “Our advice is that patients should continue to use heparin as prescribed,” he said.



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