FDA: Heparin Illnesses Now in Germany posted 6:53 pm Thu March 06, 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. In reaction, the Food and Drug Administration urged all U.S. suppliers of heparin to start using some special 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'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.
Instead, the FDA said that Germany is recalling heparin made by a German company that uses a different supplier of raw heparin ingredients than Baxter does.
ABC 7 News myTAKE - What's Your Opinion? 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 Thursday instructions for how manufacturers can do additional specialized testing for the fake ingredient.
"We're concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply," the FDA's chief medical officer, Dr. Janet Woodcock, said. "With this testing method, there'll be a way to protect the heparin supply."
German authorities were looking into the report of a contamination but would not confirm that the product had been recalled, said a German government official who requested anonymity because he was not authorized to speak about the matter.
Large doses of heparin are used for dialysis and heart surgery. Baxter competitor APP Pharmaceuticals is now the sole maker of those injections, and the FDA said APP's supply so far has tested contaminant-free.
But there are other smaller heparin manufacturers who sell the drug for different uses in the U.S., and the FDA wants them to test their supplies as well.
Woodcock said German health authorities notified their U.S. counterparts Thursday morning, reporting fewer than 100 illnesses and no deaths. But the illnesses were the same kind linked to the U.S.-recalled heparin, including allergic-type problems with breathing and low blood pressure, she said.
Baxter buys its heparin through Wisconsin-based Scientific Protein Laboratories, or SPL, which in turn owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.
The German situation "demonstrates that the heparin problem is not within Changzhou SPL's or Baxter's manufacturing facilities, but our investigation into the root cause of the problem will continue," Scientific Protein Laboratories said in a statement Thursday.
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Associated Press writer Desmond Butler contributed to this report.
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http://www.fda.govWritten By LAURAN NEERGAARD
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