US health secretary says heparin imports now safe, despite flap with China over data

By ELAINE KURTENBACH,Associated Press Writer AP - Monday, May 12

SHANGHAI, China - Imports of a blood thinner linked to dozens of deaths in the United States are now safe because of tighter testing and controls, a top U.S. health official said Monday in China.

The U.S. Food and Drug Administration has linked dangerous allergic reactions to a contaminant found in China-made shipments of the drug heparin.

"We have put in place processes that we believe can ensure the safety of the heparin supply within the United States," U.S. Health and Human Services secretary Mike Leavitt told The Associated Press in an interview in Shanghai.

Leavitt said he was optimistic that American and Chinese officials could soon resolve a dispute over the FDA's investigation into the cause of 81 deaths and hundreds of allergic reactions linked to heparin.

China's drug safety agency has accused the U.S. of blocking its own inquiry into the problem by refusing to provide details on victims and specifics about production. Beijing contends that it is too early to conclude that a contaminant found in raw heparin exported to the United States caused the adverse reactions.

"Both sides are working hard to resolve this," Leavitt said.

A report published Friday said the FDA was concerned that some medical facilities may still have heparin in stock.

The Wall Street Journal newspaper cited an FDA notice urging medical professionals to "help FDA spread the word about recalls" of heparin products.

Since problems with heparin surfaced last winter, the FDA has ordered inspections and specialized testing of all heparin imports to the U.S. All products known to have been contaminated were subject to recalls.

Washington also plans to set up an FDA office in China to help improve product safety.

Leavitt said that the need to prevent a shortage of heparin, widely used in dialysis and other common medical procedures, required that the FDA find ways to maintain the supply and quality of the drug.

"The FDA is satisfied that that which is coming into the United States is safe," he said. "Testing regimens have been put in place to ensure that."

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