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Heparin testing standards revised after deaths
Bloomberg News
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Published: 2/4/2009 3:42 PM

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U.S. scientists proposed new standards for testing the blood-thinner heparin after hundreds of deaths last year were linked to tainted Chinese ingredients.

The standards require new equipment to analyze a broader range of impurities than the interim screening tools implemented in June to protect the U.S. heparin supply from a contaminant found in some lots sold by Baxter International Inc., the U.S. Pharmacopeia said today in a statement. The nonprofit public health group, based in Rockville, Maryland, sets standards for medicines' quality, purity, strength and consistency.

"The initial, stop-gap measure quite frankly mostly would protect against the identified contaminant," Darrell Abernethy, the group's chief science officer, said today in a telephone interview. "Have we come up with a standard that would protect against the next unknown thing? We believe that we have done as good a job as is scientifically possible at this point."

The Food and Drug Administration requested revisions to the heparin standards last March when the contaminant was identified. The latest changes, scheduled to take effect Aug. 1, include three identification tests and screening for organic impurities.

Natural heparin is purified from pig intestines, then made into a shot used to prevent blood clots in millions of people with heart conditions or undergoing surgery. Before the recall, Deerfield, Illinois-based Baxter made about half of the injectable heparin used in the U.S., generating about $30 million a year in sales.

Baxter, which stopped heparin sales when the contamination was discovered, hasn't yet resumed selling vials of the blood thinner, said Erin Gardiner, a company spokeswoman, today in an e-mail.

Each year, the Pharmacopeia revises "a few hundred" of its 4,000 to 5,000 written standards, Abernethy said. The group also announced today new standards to prevent glycerin, a solvent and sweetener used in many drugs and consumer goods, from being diluted with diethylene glycol, a cheaper substance that is poisonous and found in antifreeze.