title: Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. Acute Renal Failure Investigation Team.
abstract: BACKGROUND
  Contaminated pharmaceutical products can result in substantial morbidity and mortality and should be included in the differential diagnosis of deaths of unknown origin.
  
  
  OBJECTIVE
  To investigate an outbreak of deaths among children from acute renal failure in Haiti to determine the etiology and institute control measures.
  
  
  METHODS
  Case-control study, cohort study, and laboratory toxicologic evaluation.
  
  
  METHODS
  Pediatric population of Haiti.
  
  
  METHODS
  Cases were defined as Haitian residents younger than 18 years with idiopathic anuria or severe oliguria for 24 hours or longer. Febrile hospitalized children without renal failure were enrolled as control subjects.
  
  
  METHODS
  The odds of exposure to suspected etiologic agents among cases and controls.
  
  
  RESULTS
  We identified 109 cases of acute renal failure among children. The clinical syndrome included renal failure, hepatitis, pancreatitis, central nervous system impairment, coma, and death. Of 87 patients with follow-up information who remained in Haiti for treatment, 85 (98%) died; 3 (27%) of 11 patients transported to the United States for intensive care unit management died before hospital discharge. A locally manufactured acetaminophen syrup was highly associated with disease (odds ratio, 52.7; 95% confidence interval, 15.2-197.2). Diethylene glycol (DEG) was found in patients' bottles in a median concentration of 14.4%. The median estimated toxic dose of DEG was 1.34 mL/kg (range, 0.22-4.42 mL/kg). Glycerin, a raw material imported to Haiti and used in the acetaminophen formulation, was contaminated with 24% DEG.
  
  
  CONCLUSIONS
  An epidemic of severe systemic toxicity and deaths from DEG-contaminated acetaminophen syrup occurred in Haiti. Good manufacturing practice regulations should be used by all pharmaceutical manufacturers to prevent such tragedies.
authors.affiliation: National Center for Infectious Disease, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
authors.forename: K L
authors.initials: KL
authors.lastname: O'Brien
authors.forename: J D
authors.initials: JD
authors.lastname: Selanikio
authors.forename: C
authors.initials: C
authors.lastname: Hecdivert
authors.forename: M F
authors.initials: MF
authors.lastname: Placide
authors.forename: M
authors.initials: M
authors.lastname: Louis
authors.forename: D B
authors.initials: DB
authors.lastname: Barr
authors.forename: J R
authors.initials: JR
authors.lastname: Barr
authors.forename: C J
authors.initials: CJ
authors.lastname: Hospedales
authors.forename: M J
authors.initials: MJ
authors.lastname: Lewis
authors.forename: B
authors.initials: B
authors.lastname: Schwartz
authors.forename: R M
authors.initials: RM
authors.lastname: Philen
authors.forename: S
authors.initials: S
authors.lastname: St Victor
authors.forename: J
authors.initials: J
authors.lastname: Espindola
authors.forename: L L
authors.initials: LL
authors.lastname: Needham
authors.forename: K
authors.initials: K
authors.lastname: Denerville
mesh_terms: D000082:Acetaminophen; D058186:Acute Kidney Injury / Q000453:epidemiology / Q000209:etiology*; D000293:Adolescent; D001002:Anuria; D016022:Case-Control Studies; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004196:Disease Outbreaks; D004340:Drug Contamination; D005026:Ethylene Glycols / Q000032:analysis / Q000506:poisoning*; D005260:Female; D005990:Glycerol; D006205:Haiti / Q000453:epidemiology; D006801:Humans; D007223:Infant; D008297:Male; D009846:Oliguria; D011041:Poisoning / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D012307:Risk Factors
chemical_list: D005026:Ethylene Glycols; D000082:Acetaminophen; C013484:diethylene glycol; D005990:Glycerol