Navigation Links
FDA Identifies Contaminant in Blood-Thinning Drug
Date:3/19/2008

Chemically altered form of natural compound found in heparin samples

WEDNESDAY, March 19 (HealthDay News) -- U.S. health officials say they've identified the contaminant found in the blood-thinner heparin, which has been linked to hundreds of allergic reactions and possibly 19 deaths in the United States.

The contaminant is a man-made chemical called oversulfated condroitin sulfate, but U.S. Food and Drug Administration officials could not say Wednesday how it got into the heparin. And they're not even sure it's to blame for the allergic reactions and deaths.

But Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the oversulfated condroitin sulfate was the only contaminant found in samples of the blood thinner, which was produced in China for Baxter Healthcare Corp., based in Deerfield, Ill.

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.

"It is most likely that chondroitin sulfate was chemically modified to create this compound," Woodcock said during a teleconference. "Oversulfated chondroitin sulfate, unlike common chondroitin sulfate, mimics heparin's activity, therefore appears to be heparin when subjected to standard tests."

The contaminant was found in samples of heparin that the FDA tested from Scientific Protein's Changzhou SPL plant in China, which supplied Baxter with the active ingredient in heparin, Woodcock said. It was also found in Baxter's heparin products in the United States, she said.

"Testing of these samples suggests that the contaminant accounted for approximately 2 to 50 percent of the total content of the active pharmaceutical ingredient in some of these samples," Woodcock said.

Woodcock said that the FDA doesn't know if the contaminant wound up in the heparin deliberately or by accident, and that the agency was trying to answer that question. But, she noted that oversulfated chondroitin sulfate is less expensive than the active pharmaceutical ingredient in heparin.

"Still to be determined is whether or not oversulfated chondroitin sulfate, when combined with heparin, can produce the serious allergic reactions of the sort reported to Baxter and FDA," Woodcock said.

Heparin is often given to dialysis patients and people undergoing heart surgery. The raw materials for the drug come from the mucous lining of pig intestines. Many of those pigs come from rural farms in China, with the intestines often processed by unregulated mom-and-pop workshops before further processing at Scientific Protein's plant in Changzhou.

The reported adverse reactions have included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock.

Since the end of December, there have been 785 reports of allergic reactions associated with Baxter's heparin. This compares with fewer than 100 reports of adverse reactions in all of 2007.

There also have been 46 deaths among heparin users, 19 possibly linked to the drug and four more conclusively so, according to the FDA.

However, since the lots of Baxter's heparin were recalled Feb. 28, no new deaths have been reported, Woodcock said.

Woodcock added that the FDA has been testing imported heparin entering the United States since March 14.

"Doctors and patients now can be confident that the product on the market has been tested and is safe," she said.

More information

For more on heparin, visit the U.S. National Library of Medicine.



SOURCE: March 19, 2008, teleconference with Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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

Related medicine news :

1. Iowa State University researcher identifies eye disease in canines
2. Study identifies reasons patients referred late to nephrologists
3. Weill Cornell team identifies potential new drug targets against hormone-dependent breast cancer
4. Study identifies another strategy for normalizing tumor blood supply
5. Math model identifies key to controlling epidemic
6. Study identifies which men are likely to have persistent prostate cancer
7. UCSD research team identifies novel anticancer drug from the sea
8. New Report Identifies Health Disparities and Reduction Strategies
9. Carnegie Mellon study identifies where thoughts of familiar objects occur inside the human brain
10. Scoring system identifies MDS patients who have low-risk disease but a poor prognosis
11. New neuroimaging study identifies brain signature for cigarette cravings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... ... The SeniorCare Investor will host an important webinar— Seniors Housing M&A: The ... PM ET. A recording of the webinar will also be made available following its ... want to find out what really happened in the seniors housing and care merger ...
(Date:2/22/2017)... ... February 22, 2017 , ... Pet obesity in the U.S. ... dogs, according to the Association for Pet Obesity Prevention (APOP). During the ninth annual ... issues such as the benefits of corn and grains, value of raw and organic ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... ... military veterans who suffer from combat-related PTSD. , Established in 1977, our organization ... Vietnam-era, the challenges of military returning to civilian life were evident and served ...
(Date:2/22/2017)... ... February 22, 2017 , ... In today’s world, ... solutions on the market, it is easy to start feeling frustrated and confused. ... offers a complimentary security consultation. , Home Security Hardware Choices, There are innumerable ...
(Date:2/22/2017)... Wis (PRWEB) , ... February 22, 2017 , ... ... a category by itself - the Vector™ Series Multi-Cook Oven offers up to ... oven chamber, featuring exclusive Structured Air Technology™ for unmatched evenness in cooking. Alto-Shaam ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... On Tuesday, February 21, ... Average, and the S&P 500 edged higher at ... ended Tuesday,s trading session in bullish territories. Taking ... following Medical Instruments & Supplies equities this morning: ... Bard Inc. (NYSE: BCR), Glaukos Corporation (NYSE: GKOS), ...
(Date:2/22/2017)... 2017  Applied Silver, the maker of SilvaClean®, today announced ... advisory board. Ms. Barnes is the company,s third Clinical Advisor ... and healthcare experts Scott McNealy , Josh McQueen ... J. Tress Ritter , and Leopold Selker . ... than three decades of nationally recognized clinical, nursing, and infection ...
(Date:2/22/2017)... Feb. 22, 2017  Aytu BioScience, Inc. (OTCQX: AYTU), ... novel products in the field of urology, today announced ... to 42 account managers from 35 currently, a 20% ... The sales force expansion is being driven by the ... an indication of increasing acceptance of Natesto,s unique product ...
Breaking Medicine Technology: