China supplier banned over tainted heparin

WASHINGTON – A contaminated blood thinner from China suspected in dozens of U.S. deaths has become a worldwide public health problem, with 10 other countries detecting the often-toxic ingredient, federal investigators said Monday.

The compound, which in tests mimics the blood thinner heparin but costs less to make, might have been added deliberately somewhere along a production chain that began on farms in China, beyond the reach of U.S. regulators.

Food and Drug Administration officials issued a warning letter Monday that, until the safety issues are resolved, banned future U.S. shipments from the plant in China that supplied the widely used blood thinner. And officials raised the possible death toll from 62 to 81.

At the same time, the FDA announced a major scientific breakthrough in its attempt to understand how patients became sick from the contaminated heparin.

The developments came on the eve of a congressional hearing expected to show that the FDA lacks the resources to carry out adequate inspection of thousands of foreign facilities producing a significant share of medications consumed here.

“Contamination of the heparin supply is a worldwide problem,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. Thus far in the investigation, about a dozen Chinese facilities have been identified as being part of the supply chain that handled contaminated heparin.

The ingredient that contaminated the drug, a chemically modified form of a common nutritional supplement, has been shown in laboratory and animal tests to cause the dangerous reactions that some patients experienced, Woodcock said. These included a sudden drop in blood pressure, leading to shock.

Woodcock explained that the contaminant – a compound called an oversulfated chondroitin sulfate – can trigger chemicals in blood cells that produce serious allergic-type reactions.

The FDA and Baxter Healthcare Corp., the Illinois-based company that imported heparin from China and distributed it here, have maintained that the source of the problem lies in China.

Chinese officials have remained skeptical of such a link. Instead, at a Chinese embassy news conference Monday, they urged a look at Baxter’s U.S. facilities.