2nd heparin brand causes illness
Published March 7, 2008
WASHINGTON - Dialysis patients in Germany have gotten sick using a different brand of the blood thinner heparin than was linked to 19 American deaths, U.S. officials announced Thursday, sparking concern that the problem could be more widespread than originally believed.
The Food and Drug Administration 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 in hundreds of allergic-type reactions linked to Baxter International's U.S.-sold heparin injections.
Baxter wasn't implicated in the German illnesses, and that's what raises the question of a bigger heparin problem. Germany is recalling heparin made by a German company that uses a different supplier of raw heparin ingredients than Baxter does, the FDA said.
Heparin is derived from pig intestines, and Baxter gets its supply from China, which is the world's leading source of heparin. The FDA wouldn't say whether the German company, which it identified as RotexMedica GmbH, also bought from a Chinese supplier.
Nor was it clear whether Germany has started testing its drug version for the contaminant, a compound that mimics heparin so precisely that it's not detected by standard drug-quality tests.
The FDA posted on its Web site instructions for how manufacturers can do additional specialized testing for the fake ingredient.
"We're concerned about, worldwide, this contaminant in heparin," said the FDA's chief medical officer, Dr. Janet Woodcock.
[Last modified March 7, 2008, 01:52:24]
[an error occurred while processing this directive]