Navigation Links
Researchers Identify Contaminant in Tainted Heparin
Date:4/23/2008

More testing needed to prove that oversulfated chondroitin sulphate caused deaths, reactions

WEDNESDAY, April 23 (HealthDay News) -- U.S. researchers say they've confirmed that lots of the blood thinner heparin pulled from the market are contaminated with a man-made chemical called oversulfated chondroitin sulfate.

The findings were published online Wednesday in Nature Biotechnology.

And, according to a paper published online simultaneously in the New England Journal of Medicine, the same researchers state that regulators now have at their disposal a test to detect contaminated heparin.

Regulators have said they have been hampered in their efforts to safeguard the public from contaminated heparin because of an uncertainty over exactly what the contaminant is and the lack of a test to spot such a contaminant.

"Sophisticated analytical techniques enabled complete characterization of the contaminant present in heparin. Further, this study also provides the scientific groundwork for critical improvements in screening practices that can now be applied to monitor heparin, thus ensuring patient safety," Ram Sasisekharan, senior author of the papers and the Underwood Prescott Professor of Biological Engineering and Health Sciences and Technology at Massachusetts Institute of Technology, said in a prepared statement.

On Monday, U.S. health officials said they believed that oversulfated chondroitin sulfate (OSCS) might be responsible for the dozens of deaths and hundreds of adverse reactions in the United States that have been linked with contaminated heparin between roughly last November and February.

That belief was bolstered by the fact that the U.S. Food and Drug Administration said it had identified a likely "biological mechanism" by which the oversulfated chondroitin sulfate leads to the adverse reactions seen so far, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said at a Monday news conference. Those reactions include difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, and life-threatening shock.

However, Woodcock added, "it is very important that we all be confident that we understand the link [between the contaminant and reported illnesses], to ensure that the testing that FDA and others have put in place will prevent further adverse events."

U.S. officials also announced Monday that contaminated heparin products have now been found in at least 10 countries, in addition to the United States. The officials also said contaminated lots of the blood thinner have been traced to 12 different Chinese companies that were somehow involved in heparin manufacture.

Woodcock's announcement seemed to conflict with statements made earlier Monday by Chinese health officials who said oversulfated chondroitin sulfate was not responsible for the reported injuries and deaths.

For the Nature Biotechnology paper, researchers from MIT, the FDA, and elsewhere analyzed six heparin preparations that had been linked with adverse reactions in patients, as well as four "control" preparations not associated with adverse events.

All the preparations linked with adverse reactions contained a contaminant similar to chemically synthesized OSCS, the researchers said. According to the FDA, contaminated heparin has now been linked to as many as 81 deaths and hundreds of injuries in United States.

Armed with information on the chemical structure of the contamination, experts should now be able to distinguish pure heparin from tainted heparin, the study authors stated.

The New England Journal of Medicine paper details a screening test for oversulfated chondroitin sulfate, and also demonstrates that heparin contaminated with OSCS and synthetically-derived OSCS result in side effects in pigs similar to those seen in humans.

Raw heparin is derived from pig intestines, and it's often processed by small, unregistered mom-and-pop workshops in China. Heparin is used for certain types of surgery to prevent blood clots. Kidney patients also take it before undergoing dialysis.

Oversulfated chondroitin sulfate mimics heparin's qualities and is a modified form of chondroitin sulfate. Chondroitin sulfate is a naturally occurring substance made from animal cartilage and is often used in supplements to treat arthritic joints. But, oversulfated chondroitin sulfate is man-made and doesn't occur naturally.

While the reports represent progress, many mysteries still remain, said experts.

"The fact that there's a test available will certainly be helpful and can reassure the public that the heparin being used at their respective hospitals, if a test is being used, is safe. That's good news because heparin is a ubiquitous medication," said Dr. Jack Ansell, a hematologist and chairman of medicine at Lenox Hill Hospital in New York City. "The thing that's still puzzling is is this a natural contaminant or not? We don't know where it's coming from. The nature of the chemical suggests that this is a naturally derived product. If that's the case, it means that it's been inserted or added in some sense, and that still is unclear. We need more information about that."

More information

The U.S. National Library of Medicine has more on heparin.



SOURCES: April 23, 2008, Nature Biotechnology, online; April 24, 2008, New England Journal of Medicine, April 23, 2008, news release, Massachusetts Institute of Technology, Cambridge, Mass.


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. UMass Medical School researchers awarded pediatric HIV vaccine development grant
2. Researchers identify new cell targets for preventing growth of breast and other tumors
3. Melanoma lurks in larger skin lesions, NYU researchers find
4. Reduced Funds for Cancer is Cost of Iraq, Say Ex-White House Aide, Cancer Researchers
5. MU researchers reveal communication tactics used by sexual predators to entrap children
6. Penn researchers find potential in yeast for selecting Lou Gehrigs disease drugs
7. MU researchers find clue to cataract formation
8. Researchers evaluating food allergy treatment
9. U of M researchers identify process that may help treat Parkinsons, spinal cord injuries
10. OHSU Cancer Institute researchers discover key gene involvement in cancer development
11. Combining liver cancer treatments doubles survival rates, UVA researchers find
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Researchers Identify Contaminant in Tainted Heparin
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: