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.
Baxter, Scientific Protein Laboratories and APP said they had agreed to do the testing.
To date, the FDA has received more than 785 reports of heparin reactions including 19 deaths in patients treated with some brand of heparin. Baxter said only four fatalities might be related to its heparin and there was not yet enough data to say the drug was the cause.
Heparin is derived from pig intestines and used in kidney dialysis, plus heart and other surgeries to prevent blood clots.
Scientific Protein Laboratories said the majority of lots it produced from Chinese ingredients had not tested positive for the contaminant, and it would test every new batch. The Changzhou plant is not currently producing heparin, SPL said.
Last week, Germany ordered a countrywide recall of heparin made by Rotexmedica after reports of allergic reactions there.
Additional reporting by Susan Heavey; Editing by Toni Reinhold and Tim Dobbyn