All heparin imports halted at U.S. border
FDA orders purity testing for blood thinner coming into country
WASHINGTON - U.S. 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 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 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 do not 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.
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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 larger middlemen before they reach factories like SPL's in Changzhou. The FDA has not yet inspected those workshops, saying that was something under discussion with Chinese officials.
Two weeks ago, the FDA urged all remaining U.S. heparin manufacturers to start using more sophisticated tests to be sure their products were contaminant-free. Friday, the agency said worldwide testing had begun.
The added hurdle for imports "will improve our safety net," Woodcock said. "We will get a much better picture of whether there's any contaminant existing, and we can trace it back" to its source.
Most of the actual import testing will be done by five of the nation's leading heparin manufacturers, which will be cleared to sell their products once the FDA receives those test results.
The FDA itself will test any remaining shipments that arrive from abroad.
The FDA wouldn't name the five companies that will do their own testing, and acknowledged it has no plans to do spot checks of the quality of those companies' tests.
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