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Heparin in Medical Devices
Linked to 11 U.S. Deaths
Eleven deaths and 86 cases of
harmful side effects this year have been linked to use of medical
devices containing the blood thinner heparin, U.S. regulators
said.
Most of the cases involved heparin
used to clean intravenous lines, said Karen Riley, a Food
and Drug Administration spokeswoman, in an interview.
Baxter International Inc.
voluntarily recalled its heparin, used to prevent blood clots,
beginning in January after reports of side effects. The main
ingredient in some of Baxter's heparin, made in China from pig
intestines, was later found to be contaminated.
Riley said she also couldn't
identify which companies' products were associated with the deaths
and side effects. In addition to Baxter, companies including the
device maker Medtronic Inc. have voluntarily recalled
products that may contain contaminated heparin.
The side effects and deaths linked
to medical devices occurred between Jan. 1 and May 14, according
to the FDA's Web site. Since January 2007, 81 people have died
after allergic reactions, the FDA said on April 21.
Inaccurate Tests
The FDA also said in a
posting on its Web site that contamination could lead to
inaccurate test results from diagnostic devices that monitor
heparin or use it as part of the device itself.
Ref :
http://www.bloomberg.com/apps/news?pid
=20601124&sid=aSN4RW6f45j0&refer=home.
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