Batches of Heparin Are Recalled
In France, Italy and Denmark

-Wall Street Journal

03/25/2008 -  Batches of the blood-thinning drug heparin, and some ingredients used to make it, are being recalled in France, Italy and Denmark because they are contaminated or suspected of being contaminated, a spokesman for the European Medicines Agency, or EMEA, said Tuesday.

There have been no reports of patients suffering adverse events after taking heparin in these countries, spokesman Martin Harvey-Allchurch said.

Mr. Harvey-Allchurch said the EMEA presumes that the contaminant in all three countries is the same as the one identified in U.S. batches of heparin: over-sulfated chondroitin sulfate. The EMEA presumes this because the screening test being used is specifically designed to identify that particular contaminant, he said. "We presume it is the same contaminant but it has yet to be definitively confirmed," he said.

France on Friday started recalling heparin made by Rotexmedica GmbH, the same company that made heparin that was recalled from the German market earlier this month, Mr. Harvey-Allchurch said. The recalled batches are suspected of being contaminated, he said.

In addition, active pharmaceutical ingredient used to make heparin is being recalled in Italy and Denmark because it is contaminated, he said. The active pharmaceutical ingredient was made by an Italian company, Opocrin SpA, which used raw ingredients sourced in China, Mr. Harvey-Allchurch said. Opocrin officials weren't immediately available for comment.

Mr. Harvey-Allchurch said the Chinese companies supplying Opocrin are: Henzen Hepalink Pharmaceutical Company, Shanghai Number One and Yantai Dongcheng Biochemicals. They couldn't immediately be located or reached for comment.

The recalls follow similar recalls in Germany and the U.S., where some patients who took heparin suffered allergic reactions. In both the U.S. and Germany, the contamination surfaced in batches made from ingredients bought in China.

Mr. Harvey-Allchurch said he believed that all European Union countries are now testing their heparin batches for contamination. The EMEA has been in close contact with the U.S. Food and Drug Administration on the heparin issue and has passed along the FDA's contamination screening test to all EU countries, he said.

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