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After months of investigation, the U.S. Food and Drug Administration has definitively tied three patient deaths to contaminated heparin.
Heparin is a widely used blood thinning medication, primarily administered to dialysis and cardiac surgery patients. Earlier this year, the leading supplier of heparin in the U.S. , Baxter International Inc., issued a recall over possible contamination after a spike in the number of allergic reactions.
Ninety-three deaths were reported in association with heparin use between January and the end of March, and ten of those involved death from anaphylaxis, a severe allergic reaction. The FDA concluded that three of those ten patients received heparin from contaminated batches.
“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,” said Dr. Janet Woodcock of the FDA.
Lot numbers were not available for the heparin administered to the other seven patients.
Additionally, thirteen of the remaining 83 deaths were likely due to “potential complications of heparin use,” and 25 were due to unrelated causes. For the remaining 45 deaths, the FDA said not enough clinical information was provided to determine whether contaminated heparin was to blame.
(Source: Chicago Tribune)
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