German Version of Heparin Recalled

FRANKFURT, Germany -

Germany's medical authority said Friday it has recalled a locally produced version of the blood thinner heparin believed to be linked to contaminated ingredients from China after 80 patients suffered adverse reactions.

Axel Thiele, a spokesman for the Federal Institute for Drugs and Medical Devices, told The Associated Press the drug, produced by RotexMedica GmbH, was pulled from the market Wednesday night after 80 patients suffered shortness of breath, low blood pressure and episodes of an overly rapid heartbeat.

No one taking the drug in Germany has died, he said.

"We have indications that after taking heparin, some - sometimes quite serious - side effects have occurred," Thiele said, adding that most patients who suffered a reaction were undergoing dialysis treatment,

The German institute said it believes the complications suffered by the German patients are derived from possibly contaminated ingredients imported from China, the world's leading source of heparin.

The only version of the drug that seems to be triggering a reaction in Germany so far is an inexpensive, less highly processed form, Thiele said. A more heavily processed form of heparin appeared not to be affected.

A different brand of heparin produced in the United States has been linked to 19 deaths there, according to the U.S. Food and Drug Administration. The FDA urged all U.S. suppliers of heparin to start using high-tech tests to make sure their products are free of a contaminant that is the prime suspect for hundreds of allergic-type reactions linked to Baxter International Inc. (nyse: BAX - news - people )'s U.S.-sold heparin injections.

In the U.S., heparin injections produced by Baxter International have been linked to the deaths among dialysis patients. The FDA said that, although Baxter uses different ingredients than RotexMedica, they also come from China.

A spokesman for Trittau-based RotexMedica, who declined to give his name, refused to comment to The Associated Press on Friday, but said the company was working together with authorities to clear up the incident.

Rotexmedica is owned by Groupe Panpharme, based in Fougeres, France.

Associated Press writer Melissa Eddy in Berlin contributed to this report.