 | | | | Related Healthscout Videos | |
|
Page: << Prev | 1 | 2 | 3 | Next >> In the meantime, all other heparin destined for the United States from abroad must be tested for the contaminant by the manufacturers of the drug, the FDA's Woodcock said. Five manufacturers have agreed to such testing. Any manufacturers that don't agree to test will have their products withheld by the FDA for testing by the agency, she said.
These five manufacturers that have agreed to the testing make up a "substantial" portion of the heparin supply in the United States, Woodcock said. "Manufacturers making this test commitment will be able to import the active product ingredient from overseas sources without delay to avoid shortages in supply of heparin, which would also be a very dangerous situation for patients," she said.
Heparin is a blood thinner often given to dialysis patients and people undergoing heart surgery. The raw materials for the drug come from the mucous lining of pig intestines. Many of those pigs come from rural farms in China, with the intestines often processed by unregulated mom-and-pop workshops before further processing at Scientific Protein's plant in Changzhou.
Text Continues Below
The FDA hadn't uncovered a direct link between the contaminant and the adverse reactions and deaths. "We know that some of the suspect batches of heparin that were causing the adverse events have this contaminant in it. So there is an association between the contaminant in the presence of adverse events, but it is not a direct causal link yet," Woodcock said at a March 5 press conference.
Since the end of December, there have been 785 reports of allergic reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.
There also have been 46 deaths among heparin users, 19 possibly linked to the drug and four more conclusively so, according to the FDA.
Page: << Prev | 1 | 2 | 3 | Next >>
|
.gif)
