China Confirms It’s the Source of Heparin Contaminant

-Wall Street Journal

03/20/2008 -  China’s State Food and Drug Agency has confirmed that the contaminant in Baxter’s heparin was introduced in China, Bloomberg reports.

What’s more, the contaminant — called over-sulfated chondroitin sulfate — probably entered the drug pretty far up the supply chain. Scientific Protein Laboratories said the modified chondroitin was in the raw heparin they bought in China, then processed into the active pharmaceutical ingredient to sell to Baxter. The chondroitin probably didn’t come from pigs, and may have been used to meet production targets when more than 250,000 Chinese pigs were hit by a runaway infection, the Chicago Tribune reports. It wasn’t detected by SPL’s tests.

Chondroitin sulfate is “abundant and cheap,” according to an FDA official quoted by the WSJ. It typically comes from animal cartilage. Adding sulfate — the step required to make chondroitin similar to heparin — isn’t terribly expensive, but would require a basic chemical manufacturing facility.

The modified chondroitin would clump together with real heparin in a way that would make the contaminant tough to spot in typical screening tests, an expert told the WSJ. Baxter’s heparin, now off the market, was linked to 19 deaths and hundreds of serious allergic reactions.

The FDA recently said it received permission from the State Department to put eight staffers in China, but the plan is awaiting authorization from the Chinese government, the WSJ notes.

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