Adverse reactions have now been linked to heparin made in Germany by Rotexmedica GmbH. German authorities had recalled an unspecified amount of heparin. Germany has reported fewer than 100 cases of patients suffering severe allergic reactions and shock, and no deaths.
It seems the problem lies, not only with Baxter, but with other manufacters as well. The FDA is now asking all companies in the United States that produce heparin to test their product using two new procedures. I wonder why it didn’t occur to the FDA to test heparin produced from other companies before now? Which begs the questions, is the FDA really doing its job?
Food and Drug officials said Wednesday that its possible a counterfeit ingredient had been found in certain batches of heparin that have been linked to at least 19 deaths in the United States and more than 700 severe allergic reactions. Complex testing, utilizing nuclear magnetic resonance spectroscopy and capillary electrophoresis, are the only tests that can uncover whether the drug contains this counterfeit ingredient. Federal officials said they could not yet say that the contaminant, which mimics real heparin, caused the reactions.
Until yesterday, federal investigators had been focusing on heparin manufactured by Baxter International. German health authorities told the FDA that Baxter did not make the heparin linked to two separate outbreaks of allergic reactions in that country. Last week, Baxter recalled nearly all of its heparin products. Erin Gardiner, a spokeswoman for Baxter, said reports that her company was not responsible for making the suspect heparin in Germany would most likely point to a problem with the suppliers of crude heparin. “The news today indicates that the issue could be further back in the supply chain,”
Baxter bought the active pharmaceutical ingredient for its heparin products from Scientific Protein Laboratories, based in Waunakee, Wis., which has plants in Wisconsin and Changzhou, China. All of the suspect heparin was made from raw heparin produced in China. In some cases, those supplies were produced in small, unregulated family workshops, according to heparin traders and producers in China. In a statement released Thursday, Scientific Protein Laboratories said, “We believe this 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.”
On Wednesday, Scientific Protein Laboratories announced a recall of some of its product, the active ingredient in heparin.
In the first half of last year, China exported heparin products to 42 countries and regions, according to a September 2007 report by the China Chamber of Commerce for Import and Export of Medicines and Health Products. China exported the most heparin products, about 13 tons, to Germany. It also sent 11 tons to France and about 10 tons to the United States.
Most supplies of heparin in the United States are now from APP Pharmaceuticals, of Schaumburg, Ill. APP’s supplies have undergone the new tests.
Representative John D. Dingell, the Michigan Democrat who is the chairman of the House Energy and Commerce Committee, charged in a statement released Thursday that the F.D.A. “is drowning in drug imports that it is not able to properly regulate.”
So I’m not the only who thinks the FDA isn’t doing its job.