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Contaminated Heparin®

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In late July 2008, contaminated heparin was deemed by the U.S. Food and Drug Administration (FDA) to be the cause of death of at least three patients. After reviewing 93 reports of heparin deaths that occurred in the first three months of 2008 (a period when there was a significant increase in allergic reactions and other adverse events to this anti-blood clotting agent), the FDA reported that contaminated heparin products were the direct cause of three of the deaths.

Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, said "We have what looks like a cause and effect in some patients. We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

Deaths, Complications Due to Contaminated Heparin®

Those three deaths plus another seven patients’ deaths followed the same types of symptoms, but the purity of the heparin that the other seven patients received could not be traced directly to the contaminated heparin. The FDA described the remaining 83 deaths as "potential complications of heparin use."

Possible Contamination in China

The contaminated heparin at the center of the FDA’s investigation was distributed by Baxter Healthcare and manufactured at a Baxter heparin plant in China. The heparin supply chain in China has been criticized; the oversulfated chondroitin sulfate may have been intentionally added in China at some point along the supply chain.

About half of all of the heparin products used in the U.S. are supplied by Baxter Healthcare.

The FDA continues to investigate the contaminated heparin issue, and to issue safety alerts regarding the contaminated Heparin® drug. The agency is encouraging healthcare personnel to be vigilant regarding any adverse reactions among patients given heparin treatment.

If You Have Been Injured by Heparin®

Have you or a loved one been injured after taking Heparin®? If so, contact us to speak with an experienced Heparin® attorney who specializes in drug recall litigation & lawsuits. Let us help you win the compensation you need and deserve.