The heparin problem is no longer a discrete, well-defined mess. Regulators in Germany yesterday announced that Chinese-sourced heparin sold in that country has been linked to two outbreaks of allergic reactions.
The good news: The number of patients involved is less than 100, and none has died. The bad: The suspect heparin was not made by Baxter, and its active ingredient, though originating in China, was not processed by Baxter's API supplier. Which means that more heparin circulating in the global drug supply could be tainted. And it means that investigators' focus must widen beyond the two plants operated by Baxter's supplier, Scientific Protein Laboratories. China exported heparin products to 42 countries during the first half of 2007, including 13 tons to Germany and 10 tons to the U.S.
Already there were some hints that the heparin had been tainted farther up the supply chain than those two plants; heparin turned out at both the facility in Wisconsin and the facility in Changzou was found to contain a mysterious contaminant. Though the contaminant hasn't been conclusively linked to the adverse reactions, it is a suspect. And all of the tainted heparin was made from raw heparin produced in China, some of it in small, unregulated family workshops.
The FDA is asking all U.S. heparin producers to test the product with two new, complex tests, which are the only ones able to detect the mysterious contaminant. It may be a counterfeit form of the drug. APP Pharmaceuticals makes most of the heparin remaining on the U.S. market since Baxter recalled most of its products; its supplies have undergone the new tests.
- see the FDA's call for additional heparin screening
- read the story in the New York Times
- check out the Wall Street Journal's coverage
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