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France, Italy and Denmark
join the U.S.’ decision to
recall heparin because of concerns about contamination with Chinese-made
ingredients, Europe’s drug regulator said Tuesday.
Heparin is made from ingredients taken from pig intestines
that are purified for use in humans to prevent blood clots during dialysis and
heart surgery.
A “small” number of batches were removed as a “precautionary
measure right now,” Martin Harvey-Allchurch, a representative for the European
Medicines Agency said in a telephone interview, according to Bloomberg.
The recalled products haven’t been linked to any side
effects, he added. Earlier this month, Germany
and Switzerland
announced their decision to pull some heparin from their markets.
In the U.S.,
Baxter International Inc. recalled nearly all its U.S.-sold heparin injections
after a number of patients experienced extreme allergic reactions. Moreover,
there were reported 19 deaths caused by the drug. The lots of heparin linked to
hundreds of allergic reactions were marketed by Baxter and produced in China.
The EMA presumes the contaminant in all three countries is
the same as the one identified in recalled U.S. batches of the drug, a
chemical called over-sulfated chondroitin sulfate.
Harvey-Allchurch said that European patients who need
heparin should not be affected and that the drug’s supply comes from different sources
than in the U.S.
“Our advice is that patients should continue to use heparin as prescribed,” he
said.
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