Tainted Heparin Discussed By U.S., Other Countries, FDA Says

By Justin Blum

April 18 (Bloomberg) -- The U.S. hosted a meeting of international regulators that ended today on the blood-thinner heparin, a drug linked to allergic reactions and deaths.

About 10 countries, including China, were represented during two days of discussions, said Food and Drug Administration spokeswoman Karen Riley, in an e-mailed response to questions. The FDA will release information about the meeting on Monday, Riley said, the same day the Chinese embassy in Washington scheduled a news conference.

Some samples of Baxter Inernational Inc.'s heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated with a cheaper substance derived from animal cartilage, Baxter and the FDA said last month. Sixty-two people given heparin died since January 2007 after suffering allergic reactions, according to the FDA.

The meeting of regulators was ``called to discuss what's been happening with heparin in the last several months,'' Riley said in an e-mail. She declined to provide details of the discussions and didn't respond to queries about where the meeting took place and which other countries participated.

Deerfield, Illinois-based Baxter, which sold about half the heparin in the U.S., announced a recall in January of this year. Heparin's uses include preventing blood clots during dialysis and heart surgery.

U.S. regulators suspect heparin was intentionally contaminated to increase profit, FDA Commissioner Andrew von Eschenbach told lawmakers at an April 15 hearing. He later told reporters that the agency had no evidence the contamination was intentional.

Baxter has said the contamination appears to have happened before the product reached the company's supplier. The FDA hasn't concluded where in the supply chain the tainted material was introduced.

Recalls or warnings about heparin also have been issued in Australia, Switzerland, Germany, Italy, Denmark and Japan.

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