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FDA identifies contaminant in heparin

www.philly.com

Health officials have identified a contaminant in batches of the blood thinner heparin and are trying to determine how the chemical got into the drug, which has recently been associated with 19 deaths.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28. Food and Drug Administration officials said yesterday that no new deaths have been reported since.

The contaminant was identified as oversulfated condroitin sulfate, a chemical that does not occur naturally.

Condroitin sulfate, a common natural compound, is used as a dietary supplement. But the oversulfated version has not been widely studied.

"We cannot rule in or out whether this was accidentally or deliberately introduced," said Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research. "We are investigating how it got in."

The agency has begun testing imported heparin entering the country, she said, and "doctors and patients now can be confident that the product on the market has been tested and is safe."

Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, she said. More exacting tests uncovered the contaminant.

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