Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008.

The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100 percent of case facilities vs. 4.3 percent of control facilities).” Those facilities included 21 dialysis facilities that reported reactions and 23 facilities that had no reported reactions. Adverse reactions reported included hypotension, nausea and shortness of breath. Most symptoms presented within 30 minutes of administering the drug.

All of the facilities that reported adverse reactions had vials of heparin manufactured by Baxter Healthcare that were contaminated with OSCS, according to the report. Researchers found that of the 130 reactions for which information on the heparin was available, more than 98 percent occurred in a facility that had OSCS-laced heparin on premises. Of the 54 reactions for which the lot number was known, the report shows that 96.3 percent occurred after the patients received the OSCS-tainted heparin.

According to the report, “Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.”

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