A major US
pharmaceutical company on Thursday issued a wide-spanning global recall of the
fluid used to store organs for potential transplants over fears it could be
contaminated.
Bristol Myers-Squibb (BMS) said it is recalling the fluid, called
Viaspan, across much of Europe as a part of its investigation into the problem
that was detected March 19 at a third-party manufacturing facility in Austria.
BMS issued the recall after tests found bacteria in the solution used
to monitor the sterility of the storage fluid.
"We are urgently investigating the cause of this issue," the
company said in a statement.
"BMS has notified all health authorities in countries where the
product is distributed and will provide further updates as the investigation
progresses."
Spokesman Ken Dominski told AFP the recall was being issued as a precautionary
measure and no evidence of actual contamination had yet been found.
"No evidence has been found at this point (that this)
manufacturing issue by our third party manufacturer could lead to a product
contamination and therefore we are issuing the recall as a precautionary
measure."
The recall applies to Viaspan 50mg/ml in Australia, Italy, Estonia,
Slovenia, Argentina, Chile, Germany, France, Ireland, and the United Kingdom --
all places where there are available alternatives.
The company is working with health authorities in countries where a
substitute is not available to find alternate solutions -- including Croatia,
Finland, New Zealand, Switzerland, Latvia, Lithuania, Spain, Sweden, Norway,
Denmark, Netherlands, and Belgium.
"BMS will be working with the local health authorities to find
alternative solutions for patients, and sending a Dear Healthcare Provider
Letter to physicians which includes a review of the benefit/risk for
patients," a statement said.
The company does not sell the fluid in Asia or the United States, so
those markets are unaffected, Dominski added.
The British government confirmed that there had been a global recall of
the fluid used to store most of its donor organs over fears it may have become
contaminated.
The bacteria Bacillus cereus was found in the production line of
Viaspan, the world's "gold standard" organ storage fluid, a spokesman
for Britain's Medicines and Healthcare products Regulatory Agency (MHRA) told
AFP.
The British government stressed that no patients had reported any
adverse reactions following transplants, and that it would still use organs
currently stored in the fluid.
"Our priority is to ensure patients are safe," said Sally
Davies, the government's top health advisor.
The bacteria can cause diarrhea, nausea, vomiting and stomach cramps,
but patients can be prescribed antibiotics before their operation as a
precautionary measure.
"There is currently no evidence of any problems in patients who
have recently had transplants where Viaspan has been used.
"If we were to recall the product immediately it is clear that
patients would suffer and some may die," she explained.
The last production-line tests were carried out in July, so any fluid
produced since then is at risk of contamination.
The results of ongoing tests on batches on Viaspan are due within two
weeks, according to the British health spokesman.
Kerry Sheridan
AFP
Business & Investment Opportunities
YourVietnamExpert is a division of Saigon Business Corporation Pte Ltd, Incorporated in Singapore since 1994. As Your Business Companion, we propose a range of services in Strategy, Investment and Management, focusing Healthcare and Life Science with expertise in ASEAN. We also propose Higher Education, as a bridge between educational structures and industries, by supporting international programmes. Many thanks for visiting www.yourvietnamexpert.com and/or contacting us at contact@yourvietnamexpert.com
No comments:
Post a Comment