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On March 19, 2008, Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, announced that the contaminant in Baxter’s recently recalled Heparin was "oversulfated condroitin sulfate." This compound is not Heparin, although it is in the same family as Heparin, which is why preliminary testing did not identify it.
Chondroitin or condroitin sulfate is found in most health food stores and is derived from animal products. Shark cartilage is a popular source of this product, marketed as providing elasticity to bone cartilage. Condroitin is marketed as a "Dietary Supplement" and does not undergo any pre-marketing review by the Food and Drug Administration. Producers of dietary supplements market it as a "natural compound," however oversulfated condroitin sulfate is not a natural compound and has not been widely studied.
"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," said Dr. Woodcock, "We are investigating how it got in."
What should you do? First, if you or a family member has been given Heparin since September 2007 and experienced any unusual side effects, contact your doctor's office or hospital to find out if you received Baxter's Heparin. If you received Heparin and experienced any side effects, you should also contact John Evans or Megan Faust at Specter Specter Evans & Manogue, P.C. by using the form below.
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