New heparin danger

November 6, 2008 5:53:49 PM PST
The problem with contaminated heparin isn't over yet. The Food & Drug Administration today said it had seized 11 tainted lots. And the raw material came from China.

The government says the 11 lots were taken from Celsus Laboratories Inc. in Cincinnati, Ohio.

5 of the lots sized by U.S. Marshals were of Heparin Sodium Active Pharmaceutical Ingredient (API), and six were of Heparin Lithium.

These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

Celsus is a middle-man in the pharmaceutical industry, supplying Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad. Those are components used in making the final version of heparin which goes to hospitals and doctors offices.

Heparin is a blood-thinning drug.

The FDA didn't say which drugmakers in the United States use heparin products from Celsus. However, the agency did notify authorities in Japan, Canada, Australia, the European Union, and others of contaminated heparin from Celsus.

"This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.

The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.

Earlier this year, heparin tainted with OSCS was blamed for at least 81 deaths, and dozens of injuries across the United States. Investigators say one of the key ingredients, processed by a Chinese firm, was contaminated with OSCS. The U.S. processor sold the product to Baxter pharmaceuticals, of Cherry Hill, N.J.


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