Contaminated heparin 'in Australia'
http://www.news.com.au/story/0,23599,23583526-2,00.html
CONTAMINATED blood thinner from China linked to 81 deaths in the US is
present in drug supplies in 11 countries, including Australia, the the
New York Times said today, citing US federal regulators.
http://www.nytimes.com/2008/04/22/health/policy/22fda.html?_r=1&hp&oref=slogin
The US Food and Drug Administration yesterday sent a warning letter to
Changzhou SPL, the Chinese plant identified as the source of
contaminated heparin sold by Baxter International in the United
States, the Times said.
In its letter the FDA said the plant used unclean tanks to make
heparin, accepted raw materials from an unacceptable vendor and had no
way to remove impurities, according to the Times.
The FDA has identified 12 Chinese companies that have supplied
contaminated heparin, used to prevent blood clots forming, to
Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the
Netherlands, New Zealand and the United States, the re****t said.
But it does not know the original source of the contamination or where
it entered the supply chain.
The FDA has identified the contaminant as oversulfated chondroitin
sulfate, a "cheap fake additive'' that can be detected only through
sophisticated testing, the paper said.
A Chinese official disputed the assertion the blood thinner has caused
death, but conceded that heparin produced in China contained a
contaminant.
"We don't have a strong evidence to show that it is heparin or its
contaminant that caused the problem,'' Ning Chen, second secretary of
the Chinese embassy, told the Times.
He said the illnesses associated with heparin had occurred only in the
United States, and insisted Chinese inspectors should be allowed to
inspect the US plant where the final stage of the drug's production
took place.
German regulators have also re****ted a rash of illnesses in patients
using heparin, FDA official Janet Woodcock said.
"Heparin should not be contaminated, regardless of whether or not that
contamination causes acute adverse events,'' Ms Woodcock was quoted as
saying.
"We are fairly confident based on the biological information that we
have had that this contaminant is capable of triggering these adverse
reactions.''
These include allergic or hypersensitivity-type reactions, with
symptoms including low blood pressure, shortness of breath, nausea,
vomiting, diarrhoea, and abdominal pain, according to the FDA's
website.
The FDA launched an investigation after seeing a spike in deaths
re****ted after heparin administered between November and February.
In 2006, 55 deaths were re****ted after a patient used heparin. A
variety of underlying medical conditions were involved, and only three
of the deaths listed allergic reactions or low blood pressure among
the medical events preceding death, the FDA said.
From January 2007 to the present, 131 deaths were re****ted, including
81 involving allergic reactions or hypotension, prompting a heparin
recall and the investigation.
The FDA on March 5 said it had detected an unidentified contaminant in
heparin injections sold by Baxter International.
It was determined that most of the active ingredients in the drug came
from a plant in Changzhou, eastern China working with Wisconsin-based
Scientific Protein Laboratories, which supplies Baxter.
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Notice how the gooks will lie their arses off about it rather than
simply fix the problem.
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