Saturday, March 15, 2008

Heparin Held at the Border

The federal government is stopping all heparin imports at the border so the blood thinner can undergo testing for a contaminant thought to have caused the deaths of 19 people in the United States.

The Food and Drug Administration announced the move Friday, the latest step in its widening investigation of hundreds of allergic-type reactions linked to Baxter International's heparin injections.

The FDA found the contaminant in 20 of 28 samples of raw heparin that the agency tested from Baxter's main supplier, a Chinese factory owned by Wisconsin-based Scientific Protein Laboratories.

A different brand of heparin also has been recalled in Germany after 80 patients there got sick, and the German manufacturer said Friday that it was narrowing down the source of contamination to another Chinese supplier.

FDA announced some good news Friday, saying it had learned of no additional deaths and just two more allergic reactions since Baxter recalled the last of the suspect heparin late last month.

Scientists don't yet know exactly what the contaminant is, except that it mimics heparin so closely that standard drug-purity tests won't catch it. Nor is it certain that the contaminant is to blame for the allergic reactions, although it is the prime suspect.