Drug Tied to China Had Contaminant, F.D.A. Says

Drug Tied to China Had Contaminant, F.D.A. Says | By GARDINER HARRIS and WALT BOGDANICH | Published: March 6, 2008

WASHINGTON — 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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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.

APP Pharmaceuticals, which previously split the heparin market with Baxter, has been ramping up production to meet demand. So far, APP’s products show no signs of similar contamination, Dr. Woodcock said, although some of APP’s production is also based in China.

Most of the world’s heparin supply originates in China, according to Baxter. The F.D.A. will soon make public the test used to distinguish between real heparin and its mimic in hopes that regulatory bodies around the world will adopt the test. “We don’t know if any of the heparin products worldwide might contain this contaminant, and that is something we are going to be looking into,” Dr. Woodcock said.

The F.D.A. has yet to prove that the heparin contaminant is the cause of the deaths and illnesses now associated with the use of Baxter’s product. But heparin batches associated with illnesses, all of which were produced with ingredients made in China, were found to contain the contaminant while batches not linked to illnesses proved to be untainted. In a written statement, Scientific Protein said that “it is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by S.P.L. to Baxter is responsible for these adverse events.” ...