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发帖数: 29846 | 1 By JENNIFER CORBETT DOOREN
The Food and Drug Administration said Wednesday it found 14 additional
Chinese companies supplied contaminated raw material to make heparin, a
widely used blood thinner.
The companies supplied the materials in 2008, when the FDA found a link
between contaminated heparin marketed by Baxter International Inc. to some
Chinese suppliers of the active ingredient used in heparin. The
contamination was linked to 80 deaths in U.S. patients and hundreds of
allergic reactions. The same contamination was found in heparin sold by
other pharmaceutical companies in other countries.
The 14 companies were put on a so-called import alert list that allows the
FDA to stop shipments at the U.S. border. The companies are being added to a
list that already included eight other Chinese suppliers.
Heparin is a widely used anticoagulant that is commonly used during surgical
procedures and for those undergoing dialysis, the FDA said. An estimated 12
million Americans use heparin each year.
Deborah Autor, an FDA deputy commissioner, said the agency doesn't have any
evidence that the 14 companies are currently supplying contaminated raw
materials.
"The heparin supply is safe," Ms. Autor said. "It's one of the most
protected drugs out there." Since the 2008 contamination, FDA developed a
new test to detect the contaminant in heparin and requires heparin
manufacturers to use it.
The contaminated heparin contained oversulfated chondroitin sulfate, an
altered version of chondroitin sulfate that is used as a dietary supplement
and is typically made from animal cartilage. Oversulfated chondroitin
sulfate is chemically similar to the active ingredient in heparin, which is
derived from pig intestines. Federal health officials have said it is
cheaper to make than the active ingredient in heparin. It still remains
unknown how the heparin became contaminated and who might be responsible,
although FDA is still investigating.
Douglas Stearn, a deputy director in FDA's office of compliance, said that
the companies on the blocked shipment list supply the raw material to other
Chinese companies that make the active pharmaceutical ingredient used in
heparin. The result is that it is unlikely shipments from the 22 companies
on the import alert list are actually coming into the U.S.
Mr. Stearn said there are likely hundreds of crude heparin suppliers in
China. Because China is a major pork producer, it also is a major producer
of the bulk chemical used in heparin.
The agency said it sent letters to 27 heparin manufacturers including Baxter
International informing then about them about the updated import alert and
reminding them to check their supply chains. The FDA said the additional 14
companies aren't necessarily current suppliers to any U.S. company. |
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