Investigation and pending class action against Baxter Healthcare Corporation and Baxter International, Inc alleging contaminated Heparin caused serious and sometimes life-threatening allergic reactions in some patients.
Serious reactions to the drug include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that can lead to life threatening shock.
Heparin is a vital drug used to prevent blood clots in dialysis patients and others. Sales of Baxter Heparin constitute roughly 50% of the market share in the United States. As early as November 2007, reports of adverse reactions to Baxter Heparin from 19 dialysis clinics in more than 12 states have been reported. According to the Food & Drug Administration (FDA), there have been 350 reports of adverse reactions to Baxter Heparin since December 2007, in contrast to 100 such reports the agency received in all of 2007. At least four of the reports since November, 2007 involved fatalities.
In January 2008, Baxter International, Inc. and Baxter Healthcare Corporation announced a recall of 9 lots of Heparin Sodium 1000 unit/mL vials for injection. In February, the FDA warned healthcare practitioners not to use Baxter Heparin products, and on February 29, Baxter expanded the Heparin recall to include all of its Heparin products sold in the United States. Since the Baxter Heparin recall, the FDA has confirmed that the active ingredient for Heparin that Baxter sourced from China had been contaminated with a chemical called over-sulfated chondroitin sulfate, a substance derived from animal cartilage. The FDA said that the chondroitin sulfate had been molecularly altered to mimic the blood-clotting properties of Heparin.
Do not change medications without first consulting your doctor.
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