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Scientists
Identify Heparin Contaminant |
March
19, 2008--Janet
Woodcock, director of the US FDA’s Center for Drug
Evaluation and Research, confirmed that the substance found in
batches of Baxter International’s recalled heparin is
over-sulfated chondroitin sulfate. Reuters
March
19, 2008--According to
heparin experts, a chemically altered substance called over-sulfated
chondroitin sulfate is probably the contaminant in the heparin
distributed by Baxter International in the US. However, the
researchers said they were not certain whether the contaminant is
the cause of the allergic reactions linked to Baxter’s heparin,
nor do they know precisely how or when the contaminant was mixed
into the active ingredient. The
New York Times (Free registration required)
Related:
The US FDA
has received approval from the US State Department to establish
eight full-time permanent FDA positions at US diplomatic posts in
the People's Republic of China, pending authorization from the
Chinese government. The permanent overseas offices in China will
allow greater access for inspections and greater interactions with
manufacturers to help assure that products that are shipped to the
United States meet US standards for safety and manufacturing
quality. FDA
News Release (3/14)
According
to the US FDA, all shipments of heparin—and active ingredients
made to make it—will be stopped at the US border to test the
products for signs of contamination. CNNMoney.com
(3/14)
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