By Andrea Gerlin
March 25 (Bloomberg) -- France, Italy and Denmark recalled batches of the blood thinner heparin, the latest countries to pull the medicine because of concerns about contamination with Chinese-made ingredients, Europe's drug regulator said today.
A ``small'' number of batches were removed as a precaution, European Medicines Agency spokesman Martin Harvey-Allchurch said in a telephone interview. The recalled products haven't yet been linked to side effects, he said. Earlier this month, Germany and Switzerland moved to pull some heparin from their markets.
Heparin, a drug used by millions to prevent blood clots during dialysis and heart surgery, has been linked to allergic reactions and deaths in the U.S. Baxter International Inc. withdrew heparin products in January after reports of life- threatening side effects. The Food and Drug Administration is investigating whether similar events were seen with other heparin manufacturers.
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``Since the discovery of the contaminant in the U.S., the FDA has been trying to work out a screening test,'' Harvey- Allchurch said. ``Regulators in each country have instructed the manufacturers in their countries to do the screening.''
In Italy and Denmark, the raw material for heparin has been pulled from the market, while in Germany and France, it's the finished medicine that was removed, Harvey-Allchurch said. The ingredient has been traced to four Chinese manufacturers, he said.
Germany's Rotexmedica GmbH said it recalled ``several batches'' of the blood thinner earlier this month after patients experienced allergic reactions. Switzerland's regulator asked G. Bichsel AG and B. Braun Medical AG last week to remove two heparin products from the Swiss market.
Heparin is made from ingredients taken from pig intestines that are purified for use in humans. The drug has been marketed in the U.S. since the 1930s.
To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net
Last Updated: March 25, 2008 11:29 EDT
