FDA Finds Contaminant in Baxter's Recalled Heparin Products
Tests have found a heparin-like contaminant in heparin blood-thinning products made by Baxter Healthcare Corp.
The products have been linked to hundreds of adverse reactions and at least four deaths in the United States, federal health officials said March 8, 2008.
The substance reacts like heparin in the conventional tests that are used for heparin, which is why those tests of ingredients might not detect the contaminant.
Heparin is a blood-thinner whose main ingredient comes from pig intestines. The drug is often given to dialysis patients and people undergoing heart surgery.
Since the end of December, there have been 785 reports of adverse 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, four of which were associated with an adverse reaction to heparin, according to the FDA. Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.
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