Posted on 03/19/2008 1:09:00 PM PDT by neverdem
AP Science Writer
U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.
The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.
Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.
Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.
"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."
The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."
Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. She said more exacting tests by the government and university researchers uncovered the contaminant.
Oversulfated condroitin sulfate would be less expensive to make than heparin, but FDA officials said they could not estimate the cost difference.
The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.
Baxter buys its heparin through Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.
SPL said in a statement Wednesday that the contamination occurred earlier in the supply chain.
Robert Rhoades, an independent consultant, was quoted in the statement as saying tests used by the FDA had detected "peaks" in samples of material supplied to the Chinese plant, "indicating that the contaminant was in the material before it reached CZSPL."
"We do know that heparin sourced and produced in North America by SPL has not been shown to have the same peak characteristics seen in certain lots of heparin sourced in China and has not been implicated during the investigation," the statement added.
FDA said Chinese officials have been highly cooperative in the investigation.
The investigation comes just a year after melamine was identified as a contaminate in pet food from China. Officials said an agreement signed at that time with China helped smooth the way for this investigation.
FDA officials said they could not yet directly associate the oversulfated condroitin sulfate to the deaths and side effects, but it is the lone contaminant they have found in the product.
A different brand of heparin has also been recalled in Germany after 80 patients there became sick, and the German manufacturer said it was narrowing down the source of contamination to another Chinese supplier
On Wednesday, German regulators did not say if the contaminant they are investigating is oversulfated condroitin sulfate.
Heparin is derived from pig intestines, and China is the world's leading supplier. Tiny family-run workshops near slaughterhouses send batches of raw ingredients to larger middlemen before they reach factories.
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Associated Press business writers Matthew Perrone in Washington and Matt Moore in Germany contributed to this report.
Stopped reading there. That line says it all.
Ping
Oversulfated condroitin sulfate would be less expensive to make than heparin, but FDA officials said they could not estimate the cost difference.
OH, like Melamine was less expensive than Gluten, but raised the Nitrogen assays to make the product appear better, and therefore worth more?
Like Ethylene Glycol was cheaper than Glycerine in tooth paste?
WHY are we buying food and drugs from this festering cesspool where Human Life means nothing?
1. That's a liberal newspaper “reporting” this”. When have they started telling the truth and not pushing Marxism?
2. You think liberals and their environmental laws will allow anything to made in the U.S. again? Think again. So where are we supposed to buy products from then?
3.If you owned a factory would you want to put up with all the applications for permits that last 10 years, lawsuits, regulations, taxes in the U.S.? why do you think no one makes anything in the U.S. anymore ? it's because they can't do it economically or not at all.
4. You want a perfect world where no one dies? well 5000 Americans died per year during the 1980’s from food poison and that was before the U.S. started importing from China.
20,000 Americans die from car crashes.do you and liberals think no one will ever die and we must create government agencies that will make that so? do we ban cars too?
Everyone dies sooner or later.
5. The U.S. has the highest standard of living and people live longer here and have the best health of any people ever in the world. Increasing the number of laws and government agencies to police capitalism (private companies) will only lead to socialism and the whole population starving as government can't do anything right.
6. These are mostly private companies in China producing trillions of products we need in the U.S. you think government agencies can do better quality control than the free market? think again.
that’s what we get for outsourcing stuff
I wonder if they were ‘cutting’ heparin with chondroitin sulfate to save money.
I am aware on many industrial products that have moved offshore because of burdensome EPA and OSHA regulations. However, the Sales Prices to the Customer have not materially changed. What does this imply? That the companies are pocketing the substantial difference by going to places where the waste is thrown in the river.
In the case of FDA controlled materials, we are really not talking economics or Global Trade, we are talking about compound felonies.
We still have a substantial industrial base that manufactures goods, but much has been lost by this offshoring process.
China confirms outbreak of bird flu
When Is a Heart Attack Not a Heart Attack?
FReepmail me if you want on or off my health and science ping list.
From China... that was my first thought and here it is. When will the powers that be learn?
I have to take it every time I have dialysis, 3 x a week. I’m still alive.
I have to take it every time I have dialysis, 3 x a week. I’m still alive.
While he's physically recovered from the pneumonia, he still feels pretty crummy - the littlest things tire him out. I have to believe there's a connection, but I guess in the long run, it could have been worse.
Thanks for the ping. Thanks for the post, pics and link. BTTT!
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