title: Outbreak of adverse reactions associated with contaminated heparin.
abstract: BACKGROUND
  In January 2008, the Centers for Disease Control and Prevention began a nationwide investigation of severe adverse reactions that were first detected in a single hemodialysis facility. Preliminary findings suggested that heparin was a possible cause of the reactions.
  
  
  METHODS
  Information on clinical manifestations and on exposure was collected for patients who had signs and symptoms that were consistent with an allergic-type reaction after November 1, 2007. Twenty-one dialysis facilities that reported reactions and 23 facilities that reported no reactions were included in a case-control study to identify facility-level risk factors. Unopened heparin vials from facilities that reported reactions were tested for contaminants.
  
  
  RESULTS
  A total of 152 adverse reactions associated with heparin were identified in 113 patients from 13 states from November 19, 2007, through January 31, 2008. The use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100.0% of case facilities vs. 4.3% of control facilities, P<0.001). Vials of heparin manufactured by Baxter from facilities that reported reactions contained a contaminant identified as oversulfated chondroitin sulfate (OSCS). Adverse reactions to the OSCS-contaminated heparin were often characterized by hypotension, nausea, and shortness of breath occurring within 30 minutes after administration. Of 130 reactions for which information on the heparin lot was available, 128 (98.5%) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3%) occurred after the administration of OSCS-contaminated heparin.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Epidemic Intelligence Service Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Blossom
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Kallen
authors.forename: Priti R
authors.initials: PR
authors.lastname: Patel
authors.forename: Alexis
authors.initials: A
authors.lastname: Elward
authors.forename: Luke
authors.initials: L
authors.lastname: Robinson
authors.forename: Ganpan
authors.initials: G
authors.lastname: Gao
authors.forename: Robert
authors.initials: R
authors.lastname: Langer
authors.forename: Kiran M
authors.initials: KM
authors.lastname: Perkins
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Jaeger
authors.forename: Katie M
authors.initials: KM
authors.lastname: Kurkjian
authors.forename: Marilyn
authors.initials: M
authors.lastname: Jones
authors.forename: Sarah F
authors.initials: SF
authors.lastname: Schillie
authors.forename: Nadine
authors.initials: N
authors.lastname: Shehab
authors.forename: Daniel
authors.initials: D
authors.lastname: Ketterer
authors.forename: Ganesh
authors.initials: G
authors.lastname: Venkataraman
authors.forename: Takashi Kei
authors.initials: TK
authors.lastname: Kishimoto
authors.forename: Zachary
authors.initials: Z
authors.lastname: Shriver
authors.forename: Ann W
authors.initials: AW
authors.lastname: McMahon
authors.forename: K Frank
authors.initials: KF
authors.lastname: Austen
authors.forename: Steven
authors.initials: S
authors.lastname: Kozlowski
authors.forename: Arjun
authors.initials: A
authors.lastname: Srinivasan
authors.forename: George
authors.initials: G
authors.lastname: Turabelidze
authors.forename: Carolyn V
authors.initials: CV
authors.lastname: Gould
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Arduino
authors.forename: Ram
authors.initials: R
authors.lastname: Sasisekharan
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects* / Q000737:chemistry; D016022:Case-Control Studies; D002809:Chondroitin Sulfates / Q000009:adverse effects*; D004196:Disease Outbreaks; D004340:Drug Contamination; D004487:Edema / Q000139:chemically induced / Q000453:epidemiology; D006493:Heparin / Q000009:adverse effects* / Q000737:chemistry; D006801:Humans; D007022:Hypotension / Q000139:chemically induced / Q000453:epidemiology; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D006435:Renal Dialysis; D013610:Tachycardia / Q000139:chemically induced / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014581:Urticaria / Q000139:chemically induced / Q000453:epidemiology
chemical_list: D000925:Anticoagulants; D006493:Heparin; D002809:Chondroitin Sulfates