Fears grow as China-sourced drug recalled
Germany's medical authorities announced yesterday that they had recalled a locally produced version of a blood-thinning drug that is believed to contain contaminated ingredients from China after 80 patients suffered adverse reactions.
Axel Thiele, a spokesman for the Federal Institute for Drugs and Medical Devices, said heparin, produced by RotexMedica, was pulled from the market on Wednesday night after 80 patients suffered shortness of breath, low blood pressure and episodes of an overly rapid heartbeat.
No other drug companies' products were involved, he said.
'We have indications that after taking heparin, some - sometimes quite serious - side-effects have occurred,' Mr Thiele said, adding that most patients who suffered a reaction were undergoing dialysis treatment.
A different brand of heparin produced in the US has been linked to 19 deaths there, according to the US Food and Drug Administration.
The FDA on Thursday urged all US suppliers of heparin to start using hi-tech tests to make sure their products were free of a contaminant that is the prime suspect in hundreds of allergic-type reactions linked to Baxter International's US-sold heparin injections.
Baxter was not implicated in the German illnesses, and that raises the question of a bigger heparin problem. The German institute said the complications suffered by the German patients were possibly derived from contaminated ingredients imported from China, the world's leading source of heparin.
What kind of contaminant could be involved, however, was not known, it said.
'We're concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply,' said FDA chief medical officer Janet Woodcock. 'With this testing method, there'll be a way to protect the heparin supply.'
Large doses of heparin, which is derived from pigs' intestines, are used for dialysis and heart surgery.
Baxter buys its heparin through Wisconsin-based Scientific Protein Laboratories (SPL), which owns a factory on the mainland - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.
Thick and thin
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SOURCE: MEDILINE DRUG INFORMATION