FDA close to identifying heparin contaminant

WASHINGTON Food and Drug Administration officials said that they are close to identifying the "heparin-like" contaminant found in some of the heparin causing allergic reactions, according to the Washington Post. They said that once they know exactly what the contaminant is, they will probably know whether it was deliberately added or unintentionally produced during manufacturing.

Also, the agency has said that most manufacturers have agreed to begin more sophisticated tests of heparin ingredients and products. While other manufacturers will have their tests conducted by the FDA.

Janet Woodcock, the head of the FDA's Center for Drug Evaluation and Research, said the testing is part of a formal "import alert" and will improve monitoring of the drug. "We will get a much better picture of whether there's any contaminant existing, and we can trace it back" to its sources,” she said.

Woodcock said that while they have not yet established a direct link between the contaminated heparin and the allergic reactions, there is now "a guilt by association." She said the heparin-like molecule found in the contaminated lots was similar to the drug itself and was not detected until the new refined tests were developed. FDA chemists are "close to nailing down exactly what it is," she said.