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Posted on 02/14/2008 7:48:37 PM PST by JACKRUSSELL
A Chinese facility that hasn't been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, the agency said yesterday.
The disclosure is likely to add to broad concerns about the safety and quality of products imported from China and elsewhere in the developing world. A tide of tainted goods ranging from pet food to children's toys has prompted recalls and increased scrutiny of Chinese-made wares around the world.
Although it isn't known whether the Chinese plant played a part in the drug's problems, its role as a supplier to Baxter is expected to fuel questions about U.S. regulators' ability to ensure the safety and quality of imported drugs and drug ingredients.
On Monday, Baxter announced that it had temporarily halted production of its version of the generic anticlotting drug heparin because of about 350 bad reactions potentially tied to the drug, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery.
Yesterday, both Baxter and the FDA said it wasn't clear that the ingredient from the Chinese supplier was tied to the bad reactions. "We honestly don't know" the cause, an FDA spokeswoman said.
China is now the world's largest producer of active pharmaceutical ingredients -- the chemical compounds needed to make finished pills and other drugs. In 2005, China had $4.4 billion, or 14%, of the world's $31 billion market for active drug ingredients, according to a report last year from Credit Suisse.
Recent testimony from the Government Accountability Office said that the FDA may only inspect around 7% of foreign drug-making facilities in a given year, and it would take the agency more than......
(Excerpt) Read more at online.wsj.com ...
“plants” have been tarnished this year, no? First, the do all sorts of dirty work for Hillary Rodham Clinton, now this.
There was also a lot of heparin that was linked to sepsis in a number of patients. I had a patient who got cellulitis of the abdominal wall following a heparin injection, same time frame - could have been bad technique, I suppose.
Brilliant to get pharma from our sworn enemies. Bad medications or vaccines could wipe out hundreds of thousands before we knew what hit us. Our stupidity grows in parallel to our greed.
I never knew a hematoma could be so painful, and debilitating. The article does not state anything about hematomas resulting from this, but I sure will do more research and talk with my doctor. Thank you so much for posting this!
Ping.
You can imagine how relieved I am now.
“Our stupidity grows in parallel to our greed.”
Well said. That would make a good tagline.
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