Allergic drug reactions case study

Drug contamination Adverse reactions to heparin contaminated with oversulfated chondroitin sulfate have been evaluated in a US case-control study of patients in dialysis facilities who had signs and symptoms of allergic reactions after 1 November 2007 [122 ]. There were 152 adverse reactions associated with heparin in 113 patients from 13 states from 19 November 2007 to 31 January 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions, which occurred in 100% of 21 facilities in which cases were reported versus 4.3% of 23 control facilities. Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate. Adverse reactions to the contaminated heparin were often characterized by hypotension, nausea, and shortness of breath within 30 minutes of administration. Of 130 reactions for which information on the heparin lot was available, 128 occurred in a facility that had contaminated heparin on the premises. Of 54 reactions for which the lot number of the heparin was known, 52 occurred after the administration of contaminated heparin. 

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