China says chemical not source of heparin woes

-Reuters

04/21/2008 -- A Chinese investigation concluded that a contaminant found in the blood thinner heparin was not the cause of deaths and allergic reactions related to the drug in the United States, a Chinese health official said on Monday.

Investigators tested batches of heparin used by patients who reported those health problems, and only some contained the contaminant, an altered form of chondroitin sulfate, said Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products.

"The oversulfated chondroitin can therefore not be the suspected root cause of heparin ADE (adverse events)," he told reporters.

The U.S. Food and Drug Administration has said their investigation found some batches contained oversulfated chondroitin sulfate, which mimics the blood-thinning effects of heparin, but has not officially linked it to the problems.

Baxter International Inc recalled most of its heparin products in February after the reported reactions inpatients treated with the blood thinner, which is used in kidney dialysis and various surgeries to prevent blood clots.

The active ingredient is derived from pig intestines and often collected from small, mostly unregulated farms in China.

FDA officials are trying to determine if the altered chemical is responsible for as many as 62 deaths and hundreds of reactions reported in heparin patients.

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