Frankfurt: Assenting to comments by the U.S. Food and Drug Administration (FDA), Germany has dictated countrywide recall of blood-thinner heparin, manufactured by Rotexmedica. The Order from Germany health authorities came in wake of several dialysis patients getting sick after using a different brand of the blood thinner, heparin. Linked to 19 American deaths, heparin has been recalled on fears of contamination.
Coordinating the recall with the healthcare department of the German state of Schleswig-Holstein, the Federal Institute for Drugs and Medical Devices, Department Chief, Ulrich Hagemann said, "There is suspicion that batches of heparin produced by Rotexmedica have been contaminated."
According to Hagemann, the makers of drug could be using active ingredients from China, which are believed to be responsible for three severe cases of allergic reaction had been reported so far.
However, no one from Rotexmedica, a unit of French company Panpharma, was immediately available for comment.
Responding to Germany’s fears that have certainly question marked the safety of European supplies of the drug, the US FDA has urged all the U.S. suppliers of heparin to conduct some special high-tech tests to make their products totally free of contaminants, which are believed to be the reason for hundreds of allergic-type reactions linked to Baxter International's U.S.-sold heparin injections. The FDA has started investigating 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, FDA reported that it had identified a contaminant that might be linked with the drug's problems. Some 19 fatalities have now been associated with use of the drug in the United States, but none of the deaths have been linked to a specific drug maker.
According to the FDA, Heparin is derived from pig intestines. It is used in dialysis and heart procedures, among other surgeries, to avoid blood clots. Its makers get its supply from China, which is the world's leading source of heparin.
However, the FDA said that Germany was recalling heparin made by a German company that uses a different supplier of raw heparin ingredients than Baxter does. The agency has not got clear proofs whether the German company, which it identified as RotexMedica GmbH, also bought from a Chinese supplier.
The agency has posted instructions for how manufacturers can do additional specialized testing for the fake ingredient on its official website.
The FDA's chief medical officer, Dr. Janet Woodcock, said, "We're concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply," "With this testing method, there'll be a way to protect the heparin supply."
