FDA orders all heparin imports tested on entry

Purity cited after 19 deaths reported

WASHINGTON - US health officials have ordered all imports of the blood thinner heparin, and its raw ingredient, stopped at the border for testing to detect a contaminant linked to 19 deaths.

The Food and Drug Administration disclosed the move yesterday, 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 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 yesterday it was narrowing down the source of contamination to another Chinese supplier.

The FDA yesterday said it had not learned of 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 the contaminant is to blame for the allergic reactions, although it is the prime suspect.

But the FDA is "very close" to identifying the substance, a step that should help tell if the contaminant got into heparin by accident or by fraud, said FDA drug chief Dr. Janet Woodcock.

Heparin is derived from pig intestines, and China is the world's leading supplier. Tiny family-run workshops near slaughterhouses send batches of raw ingredients to middlemen before they reach factories like SPL's in Changzhou. The FDA hasn't yet inspected those workshops, saying that was something under discussion with Chinese officials.

Two weeks ago, the FDA urged all US heparin manufacturers to use more sophisticated tests. Yesterday, the agency said worldwide testing had begun.