http://www.nytimes.com/2008/03/06/health/06heparin.htmlWASHINGTON — Federal drug regulators said Wednesday that a critical blood thinner that had been linked to at least 19 deaths and whose raw components were produced in China contained a possibly counterfeit ingredient that mimicked the real drug.
Routine tests failed to distinguish the contaminant from the drug, heparin. Only sophisticated magnetic resonance imaging tests uncovered that as much as 20 percent of the product’s active ingredient was a heparin mimic blended in with the real thing. Federal officials said they did not know what the contaminant was.
“At this point, we do not know whether the introduction was accidental or whether it was deliberate,” said the Food and Drug Administration’s deputy commissioner, Dr. Janet Woodcock.
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Beginning in November, public health officials received reports of patients experiencing severe allergic reactions after being given Baxter’s product. Baxter initiated a series of recalls that culminated last week in a withdrawal of nearly all of Baxter’s heparin production.
The F.D.A. has now received 785 reports of serious injuries associated with the drug’s use. Forty-six deaths have also been reported to the agency, but Dr. Woodcock said that just 19 of these appeared related to the suspect heparin. Baxter executives said that the total death toll was actually four.