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Posted on 03/08/2008 6:41:50 AM PST by JACKRUSSELL
(WASHINGTON) -- A recalled blood thinner made with active ingredients from China appears to have been contaminated by a mysterious look-alike substance, now the focus of an investigation into as many as 19 U.S. deaths and nearly 800 serious drug reactions, federal officials said Wednesday.
The drug -- heparin -- is a generic medication given to prevent blood clots. The manufacturer, Illinois-based Baxter Healthcare Corp., issued recalls last month after it noticed an unusual increase in reports of severe side effects.
The Food and Drug Administration's findings raised questions about whether the medication was deliberately contaminated or whether some problem occurred in processing, either in China or in the United States.
FDA officials said the as-yet unidentified contaminant was detected only through sophisticated testing not generally done by manufacturers or their suppliers. In the kinds of routine tests required before the drug was shipped, the contaminant apparently behaved much like heparin, and its presence went unnoticed.
"This substance . . . appears to act like heparin," said FDA Deputy Commissioner Janet Woodcock, calling the case "a classic chemical investigation."
A case of deliberate contamination would echo last year's massive pet food recall, prompted by a chemical that a supplier in China mixed with food to boost the product's performance in nutritional testing.
FDA officials cautioned that the investigation was at an early stage and that they were still seeking answers to many basic questions. Indeed, investigators have yet to establish whether the suspect ingredient actually caused the severe reactions -- including life-threatening drops in blood pressure -- seen in some patients.
"There is an association between the contaminant and the presence of adverse events, but it is not a direct causal link yet," Woodcock said.
The agency has come under fire from Congress because it failed to inspect the Chinese......
(Excerpt) Read more at latimes.com ...
Thanks very much for posting. My wife was given heparin last week. She has low blood pressure to begin with. Sheesh. Dodged a bullet there.
Didn't know that. What will Muslims do?
Millions of people take heparin every day. If this was wide spread millions of people would be dropping. The world dodged a bullet. We spend $trillions to comply with government regulations and we are still at the mercy of pigs like this. What are we getting for our money?
Good point. It will be very interesting to see the root cause...how small were the lot sizes, why was it not more widespread, etc., etc.
Another point to ponder...I have yet to read WHERE these 19 deaths occurred or WHERE the over 800+ reactions occurred. I have read several reports on this with interest. If you find any information please ping me. Thanks.
Why would we after all that happened lat year be importing something as important as a raw material for use in drugs from China unless that was the only possible source?
I do believe that we produce pig’s intestines in the US.
If pig’s intestines are vastly cheaper from China I would think that batch testing of each lot would not be terribly burdensome.
This borders on willful ignorance.
Didn't know that. What will Muslims do?
Die?
Isn’t this the same thing that almost killed Dennis Quaid’s newborn twins?
No. His babies were given the wrong dose.
There’s a pattern here...
"We do not know whether it inadvertently got into the supply or was added," {Woodcock] said.
Woodcock offers with a straight face the possibility that this was inadvertent. Of all the contaminants in the universe, the one that manages to stumble its way into batches of heparin is--surprise!--a substance that just happens to cleverly mimic heparin on a molecular level sufficient to fool the CQ tests.
What is patently obvious to all but the willfully and criminally blind is that the Chinese have developed a counterfeit heparin that evidently is much cheaper than the real deal. Book 'em, Dano.
Bump.
Is there any current legislation to stop trading with china?
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