Chinese Raises Heparin Doubts
As FDA Reiterates Concerns
Associated Press
April 21, 2008 3:21 p.m.
WASHINGTON -- Chinese officials voiced doubts Monday that a contaminant identified in the blood thinner heparin was the root cause of severe allergic reactions, while the Food and Drug administration said it still had doubts that Chinese suppliers had taken adequate steps to remove the contaminant.
Chinese officials suggested at an embassy news conference that the problem with the drug could have occurred in the U.S. They plan to visit a Baxter International plant in Cherry Hill, N.J., to get a better picture of how the finished product is manufactured.
"When you see it, then you believe it," said Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China.
Raw heparin is derived from pig intestines, often processed by small, unregistered workshops in China. The raw ingredient for Baxter's recalled heparin came from Wisconsin-based Scientific Protein Laboratories, which in turn owns a Chinese factory -- Changzhou SPL -- and buys additional raw heparin from other Chinese suppliers.
The Food and Drug Administration said Monday that Changzhou has not addressed all the deficiencies raised during a February plant inspection. The FDA sent the company a warning letter Monday detailing the agency's concerns.
In the letter, the FDA noted that while Changzhou has responded to the agency on March 17 and April 15 about the concerns raised in the inspection, the agency said "your response does not further address some of the deficiencies."
The FDA said there's no assurance that the processing steps used to manufacture heparin sodium "are capable of effectively removing impurities."
The Food and Drug Administration has counted 62 deaths from allergic-style reactions that were associated with recalled heparin batches. The FDA can't say for sure what caused the reactions, but the chief suspect is a contaminant that the agency discovered in supplies of raw heparin coming from China -- a compound derived from animal cartilage that so closely mimics heparin that routine purity tests can't detect it.
Germany also discovered the contaminant and recalled batches of heparin after some patient illnesses.
But the Chinese officials contended Monday that batches not containing the contaminant -- called oversulfated chondroitin -- also have been associated with side effects.
"The oversulfated chondroitin can therefore not be a suspected root cause of heparin adverse events as reported in U.S. media previously," Mr. Shaohong said.
The FDA did not immediately respond, but Baxter denied that claim.
"We do not agree with that," said Baxter spokeswoman Erin Gardiner. "We have seen adverse event reports on batches where the contaminant has been confirmed to be present."
Baxter was considering the Chinese officials' request for additional heparin samples for their own further testing, Ms. Gardiner said.
The Chinese officials also said that aside from the U.S. and Germany, more than 10 other countries used heparin containing the contaminant to produce their final injection but reported no side effects. The officials also noted that the implicated Changzhou factory was managed and overseen by a manager from its U.S. headquarters.
--Jennifer Corbett Dooren contributed to this article.
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