Posted on 12/08/2008 4:57:48 PM PST by JACKRUSSELL
A team of researchers has confirmed that a contaminant found in several batches of the blood-thinner heparin is linked with severe allergic reactions in patients, dozens of whom died after receiving the tainted drug.
A study conducted by the researchers provides epidemiological evidence that contaminated batches of heparin produced in China sickened hundreds of people, said MIT Professor Ram Sasisekharan.
Sasisekharan is the senior author of the study, which appears in the Dec. 3 online edition of the New England Journal of Medicine.
The tainted heparin scandal is among several recent contamination incidents involving products from China. It unfolded between November and January, when hundreds of patients in the United States and several other countries suffered allergic reactions after receiving the drug, often administered during dialysis or heart surgery. The tainted heparin came from factories in China that manufacture the drug for Baxter International, which recalled its heparin in February.
In April, an international team led by Sasisekharan identified the chemical structure of the contaminant, oversulfated chondroitin sulfate (OSCS), and demonstrated the biological mechanism for how it could cause severe allergic reactions in humans.
The new NEJM study epidemiologically connects the adverse reactions to the OSCS-contaminated heparin. Of the 152 adverse reactions the researchers studied, 98.5 percent occurred in facilities that received heparin tainted with OSCS.
"This study provides additional confirmation that oversulfated chondroitin sulfate caused the adverse reactions seen in patients," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
The study also shows that the patients' reactions were consistent with the biological reaction provoked by the contaminant......
(Excerpt) Read more at physorg.com ...
Thanks for the story.
FYI
I guess it pays to read carefully. At first glance I could not understand how a “hair pin” could get any one sick.
Its like beating our heads against a wall. China will continue to do as they please and companies will continue to risk the lives of consumers because it’s cheap.
I was on dialysis last year when this happened; thankfully, my dialysis center didn’t have any of the contaminated batches.
The problem with something like this is that the vast majority of dialysis patients get Heparin at each treatment (to avoid clotting); when it happens, it affects so many people, yet being a “captive audience”, the patient has no control over it.
This actually happened to my Mom about two years ago. Doctors swore to her that allergic reactions from heparin were one in a million. But she just KNEW, and persisted. Finally an ER doctor agreed, and started treating it as such. Damn near lost her, too!
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