FDA detaining imported heparin for tests

By Lisa Richwine

WASHINGTON (Reuters) - U.S. health regulators said on Friday they have ordered the detention of all imported supplies of heparin blood-thinner products so they can be tested for possible contamination.

The move is part of an investigation into serious reactions and deaths reported in patients treated with Baxter International Inc's version of heparin. The company recalled most of its U.S. supplies of the drug last month.

"We will be stopping all heparin products slated for import and assuring that manufacturers are testing them, or we will be testing them ourselves," Dr. Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, told reporters during a conference call.

The FDA said the detention order was issued on Monday.

FDA officials previously identified a contaminant in some of the drug's active ingredient supplied to Baxter by a plant in Changzhou, China, owned by Wisconsin-based Scientific Protein Labs. They have not determined if the contamination caused the reactions, which include breathing problems and drops in blood pressure.

Twenty out of 28 samples from the Changzhou plant recently tested positive for the contaminant, which is a chemical similar to heparin, Woodcock said.

Baxter and APP Pharmaceuticals Inc have been the two major U.S. heparin suppliers, but other smaller companies manufacture and sell the drug.

Five companies have agreed to test for the contaminant, FDA officials said. The agency would not name the companies or say where they are located, but said they represented the majority of the U.S. heparin market.