Plant in China linked to troubled drug

Published: Feb. 14, 2008 at 8:39 AM

WASHINGTON, Feb. 14 (UPI) -- The U.S. Food and Drug Administration has traced the active ingredient in Baxter International Inc.'s troubled blood-thinning drug to a facility in China.

Baxter, which makes half the U.S. supply of heparin, stopped production of the anti-clotting drug this week. Baxter's version of heparin, which sells at the rate of 100,000 vials a day, has been implicated in four deaths. Additionally, 350 allergic reactions have been reported to the FDA this year.

The FDA said they haven't inspected the Chinese plant that makes the ingredient and that it only inspects around 7 percent of foreign pharmaceuticals each year. The FDA told the Government Accountability Office it "cannot provide the exact number of foreign establishments that have never been inspected," The Wall Street Journal reported Thursday.

APP Pharmaceuticals Inc., another major supplier of heparin, which is used before heart surgery and kidney dialysis, also imports an active ingredient from China, the report said. But, APP Pharmaceuticals hasn't reported any problems.

The cause of the problem with Baxter's drug hasn't been discovered. "There have not been changes," in the Chinese facility recently, a Baxter spokeswoman said. Implicating the Chinese plant is "not a foregone conclusion," she said.

© 2008 United Press International, Inc. All Rights Reserved.
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