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Producers of heparin turn up scrutiny of supply chain
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bleachedblack
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Producers of heparin turn up scrutiny of supply chain
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on:
March 09, 2008, 01:43:43 PM »
Producers of heparin turn up scrutiny of supply chain
March 8, 2008
As worries over the heparin blood thinner critical to hospitals and dialysis centers spread to Europe, Chicago-area makers of the product said Friday that they are ratcheting up scrutiny of their own product supply chains in China and the U.S.
The moves come in the wake of alerts from the Food and Drug Administration, which is searching for the cause of deadly allergic reactions in the U.S. from heparin made by Deerfield-based Baxter International Inc. and sourced from China.
A huge producer of pigs, China is the largest supplier of the enzyme found in the mucous lining of the animal's intestines that is needed to produce heparin. Investigators are looking in China for an answer to the mystery and are focusing partly on the fact that suspect "heparin-like" material was found in Baxter's product.
The suspicious material may have been introduced intentionally before the product reached Baxter's U.S. factory in New Jersey, the FDA said. Baxter got its heparin from a plant in Changzhou, China, which was sourced by village workshops and rural pig lots. The plant is owned by Wisconsin-based Scientific Protein Laboratories
Blood-thinner companies are reacting as well to warnings from European authorities that more than 80 similar allergic reactions have been linked to China-sourced heparin made by Germany-based Rotexmedica, though a cause is not yet known.
Complex tests not previously a part of the FDA's heparin inspection process, known as nuclear magnetic resonance spectroscopy and capillary electrophoresis, are being used by heparin-makers.
>>>>the complete article
http://www.chicagotribune.com/features/lifestyle/health/chi-sat_baxter-fdamar08,1,7438201.story
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bleachedblack
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Re: Producers of heparin turn up scrutiny of supply chain
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March 16, 2008, 01:18:36 PM »
China, US Probe Heparin Blood Thinner
March 16, 2008
BEIJING (AP) — China and the United States are working together to investigate the blood-thinner heparin, which has been linked to 19 American deaths, China's food and drug administration said Sunday.
The U.S. Food and Drug Administration has been widening its investigation into the hundreds of adverse reactions — including difficulty breathing, nausea and falling blood pressure — linked to U.S. health care company Baxter International's heparin injections.
Heparin is derived from pig intestines, and China is the world's leading supplier.
U.S. and Chinese officials have been investigating heparin samples but have reached no conclusions, Wu Zhen, the deputy commissioner of China's State Food and Drug Administration, said Sunday.
"China's State Food and Drug Administration and America's FDA are working closely together on the heparin investigation, and American investigators came to China to investigate and we supported them," Wu said at a news conference.
"The most important thing now is that the scientists of both sides launch an in-depth investigation into the details," he said. "We can't take effective measures until we find the cause."
The U.S. FDA found a contaminant in 20 of 28 samples of raw heparin from Baxter's main supplier, Scientific Protein Laboratories of the United States, which gets the bulk of its heparin from a joint venture in China's east Jiangsu province.
Scientists don't yet know exactly what the contaminant is, except that it mimics heparin so closely that standard drug-purity tests will not catch it. Nor is it certain that the contaminant is to blame for the allergic reactions, although it is the prime suspect.
>>>the complete article
http://ap.google.com/article/ALeqM5hWgGiNdCZNVSuZPlkQ38lLrPnAJQD8VEH92G0
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bleachedblack
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Re: Producers of heparin turn up scrutiny of supply chain
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April 22, 2008, 06:43:12 PM »
Contaminated heparin found in 11 countries; 81 dead in U.S.
Apr. 22, 2008
The Food and Drug Administration said Monday that contaminated heparin, a blood thinner, has been detected in 11 countries and that the number of U.S. deaths potentially linked to the contamination has risen to 81, up from 62.
The contamination is "a worldwide problem," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. U.S. supplies currently in circulation have been tested and are safe, she added.
The contaminated raw product that went into the heparin came from 12 companies, all located in China, the FDA says. The affected countries are Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.
Baxter International, the largest supplier of heparin in the United States, recalled most of its heparin products in February.
The contaminant is called oversulfated chondroitin sulfate. Some patients exposed to contaminated heparin have experienced severe allergic reaction, and scores have died, says the FDA's Deborah Autor.
Testing has shown that the contamination may have begun as early as 2006, with tainted products entering the global market in 2007, Woodcock says. U.S. deaths began to spike in November, but fell to zero in March after the Baxter recall.
The contaminated heparin has been found in intravenous-drug products, IV-flush products and some medical diagnostic and in-vitro diagnostic tests.
All the contaminated raw product was produced in China, but the FDA does not know how or why it was introduced into the blood thinner.
Chinese officials do not dispute that the heparin coming from their country was contaminated. However, they have said they do not believe the allergic reactions and deaths in patients taking heparin are linked to the contamination.
http://www.azcentral.com/news/articles/2008/04/22/20080422heparin0422.html
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bleachedblack
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Re: Producers of heparin turn up scrutiny of supply chain
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Reply #3 on:
May 18, 2008, 10:39:35 AM »
FDA Issues Updated Heparin Alerts to Medical Facilities
May 9, 2008
WASHINGTON -- The Food and Drug Administration stepped up its heparin alerts to hundreds of hospitals, medical societies and pharmaceutical organizations on Friday after learning that some medical facilities still had the contaminated blood thinner among their supplies.
The FDA's reminders followed information on the recall from the California Department of Health, the FDA's own recall monitoring, and from Baxter International Inc., the largest supplier of heparin, showing gaps in the recall response.
"Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement," the notice read. "Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used," it said.
A spokeswoman for the FDA said that California authorities had sent a letter out on May 2 about gaps in the recall response.
"They checked and found more than a handful of hospitals had not removed all contaminated heparin," said Karen Riley of the FDA. "We found it on crash carts, catheter labs, and even on one hospital pharmacist's shelf," she added. The additional alert should spur hospital surgery, cardiac and dialysis centers, which use a lot of heparin, to recheck for any contaminated heparin lots.
http://online.wsj.com/article/SB121037274108181673.html?mod=googlenews_wsj
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bleachedblack
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Re: Producers of heparin turn up scrutiny of supply chain
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Reply #4 on:
June 30, 2008, 04:43:14 PM »
Heparin Prices are Soaring
June 29, 2008
It is a case of supply and demand with regard to the blood-thinning drug heparin. Since the recall of heparin earlier this year, supplies have become very limited, so an increase was to be expected.
For example, "At Renal Advantage's 90 dialysis centers, prices have gone up twice since mid-April, says Angela Newman, vice president. DaVita, which has 1,300 dialysis centers, has seen a similar jump, says spokeswoman Stephanie Horn." The increase shows no immediate signs of leveling off. The costs of crude heparin alone, which is imported from China, have risen 500% since the beginning of this year.
http://lancaster.injuryboard.com/fda-and-prescription-drugs/heparin-prices-are-soaring-.aspx?googleid=242838
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