Germany orders recall of blood-thinner heparin
March 10, 2008
According to Reuters, Germany has ordered a countrywide recall of blood-thinner heparin, made by Rotexmedica, on fears of contamination, a German health official said, confirming comments by the U.S. Food and Drug Administration.
The Federal Institute for Drugs and Medical Devices has coordinated the recall with the healthcare department of the German state of Schleswig-Holstein.
Officials said the drug could be using active ingredients from China, adding that three severe cases of allergic reaction had been reported so far.
Rotexmedica, a unit of French company Panpharma, was not immediately available for comment.
Heparin is derived from pig intestines and is used in dialysis and heart procedures, among other surgeries, to avoid blood clots.
The recall brings into question the safety of European supplies of the drug, which became the target of a U.S. investigation after a spike in fatalities and severe reactions in some patients taking heparin sold by Baxter International.
The FDA began probing Baxter''s heparin several weeks ago after it was linked to four deaths and hundreds of severe reactions, such as breathing problems and rapid drops in blood pressure. On Wednesday it said it identified a contaminant that may be linked with the drug''s problems.
Some 19 fatalities have now been associated with use of the drug in the United States, the FDA said on Wednesday. However, none of the deaths have been linked to a specific drug maker.