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drug_recall heparinThe heparin recall in February 2008 was of nearly all of the heparin products supplied by Baxter International, a company that provides half of the heparin used each year in the United States. The recalled heparin may be contaminated and includes:
Heparin is most often administered by healthcare professionals in a hospital or clinic setting, but there are also home-use heparin kits for patients to use themselves.
Dangerous Side Effects, Fatalities
More than 700 cases of severe reactions to heparin products were reported to Deerfield, Illinois-based Baxter before the recall. Nineteen deaths have been linked to heparin reactions since Jan. 1, 2007, and the U.S. Food and Drug Administration (FDA) has received more reports since the recall of adverse events following heparin use.
Heparin side effects include:
Heparin from China
The heparin provided by Baxter is from their heparin supplier, Wisconsin-based Scientific Protein Laboratories (SPL), which in turn obtained the heparin from its factory in Changzhou, China. FDA Deputy Commissioner Janet Woodcock stated in March 2008 that "At this point we don't know how the heparin-like compound got into the active pharmaceutical ingredient…we don't yet have a direct causal link between the contaminant and the adverse events."
Heparin appears to be yet another example of a dangerous, poor-quality product imported to the U.S. from China, echoing the recalls of toys, tires, toothpaste and more from that country.
From Pig Farms
A Baxter spokesperson was asked why the ingredients for heparin are imported from China. She stated that not enough heparin can be produced domestically to meet the high demand. Most heparin is made from the mucosal tissue of the intestines of pigs, and it is on factory farms in China that the pigs are raised and slaughtered.
It is not yet known whether the contaminating ingredient in recalled heparin was included accidentally or purposely.
FDA Urging Heparin Testing
In light of all the adverse reactions to heparin, the FDA is now recommending that pharmaceutical companies and their suppliers test all of their heparin products for foreign ingredients. The other major heparin supplier in the U.S., Schaumburg, Ill.-based APP Pharmaceuticals, stated that it hasn't detected any problems with its heparin.
Find Out More about the Heparin Recall
If you're concerned about the quality of heparin with which you've been treated, contact us for further information about the heparin recall or to learn more about your legal rights.
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