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Last Updated: Apr 16, 2008 - 5:52:06 PM |
FRIDAY FEB 29, 2008 (Foodconsumer.org) -- Baxter International is recalling all brands of the blood thinning heparin as the death toll associated with use of this drug increased to 21 from 4 reported early. Baxter supplies half of the market volume, but the Food and Drug Administration said other suppliers have the capacity to fill the gap. Early the agency allowed Baxter not to recall certain products fearing that recalling all products could leave the market demand unmet.
The focus has been on a Chinese plant that has supplied Baxter raw heparin material for a couple of decades. But the suspected problem is a safety issue because the FDA had not inspected the manufacturer ever until the incident. The FDA later found that at lease one instance of the company using active ingredients made from pig intestines supplied by others was unacceptable, the Washington Post reported.
FDA officials said the root cause of the problems linked to Baxter's heparin has not been found. Although the Chinese plant identified as Changzhou SPL, located near Shanghai, had not been inspected early, it remains virtually unknown whether the factory had anything to do with the increased risk of deaths linked to heparin.
Michael Rogers, the FDA's director of field investigations was cited as saying that the heparin refining plant has been inspected, but officials still are looking at the data. The inspectors in China are now looking into "consolidators" or the wholesalers who collect the heparin active ingredients from smaller processors and sell it to companies like Changzhou SPL.
Changzhou SPL is not a Chinese company some people would think of and it is actually owned largely by an American company, Scientific Protein Laboratories of Waunakee, Wis. SPL President David Strunce was cited by the Washington Post as saying in a statement that the FDA has not determined the Chinese plant was the source of the heparin problem.
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