Deaths Linked to Contaminated Heparin

According to an Article in The Chicago Tribune, the Food and Drug Administration conclusively has linked 3 patient deaths to a foreign substance found in specific lots of Heparin, a drug manufactured by Baxter International. According to the news report, the FDA completed its review of 93 reports of deaths related to Heparin that were received from January through the end of March, a period when there was a huge spike in the potentially deadly allergic reactions from patients who had been injected with this medication. Three (3) of the deaths could be traced to lot numbers of Baxter products that had tested positive for an animal like substance known as oversulfated chondroitin sulfate.
According to Janet Woodcock, Director of the FDA’s Center of Drug Evaluation and Research, “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.”
Baxter recalled this product in February in the wake of the number of allergic reactions reported. Earlier this year, the FDA had announced that there were reports of more than 90 deaths and 1,000 adverse events associated with patients in the U.S. who had used this product. While some of the reported deaths now do not appear to have been related to contaminated Heparin, in many cases, the clinical information available was simply insufficient to specify the cause of death with “clinical certainty.” The government investigation continues.