title: Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation.
abstract: BACKGROUND
  Botulism is a potentially lethal paralytic disease caused primarily by toxins of the anaerobic, spore-forming bacterium Clostridium botulinum. Although botulinum toxin A is available by prescription for cosmetic and therapeutic use, no cases of botulism with detectable serum toxin have previously been attributed to cosmetic or therapeutic botulinum toxin injections. On November 27, 2004, 4 suspected botulism case-patients with a link to cosmetic botulinum toxin injections were reported to the Centers for Disease Control and Prevention.
  
  
  OBJECTIVE
  To investigate the clinical, epidemiological, and laboratory aspects of 4 suspected cases of iatrogenic botulism.
  
  
  METHODS
  Case series on 4 botulism case-patients.
  
  
  METHODS
  Clinical characteristics of the 4 case-patients, epidemiological associations, and mouse bioassay neutralization test results from case-patient specimens and a toxin sample.
  
  
  RESULTS
  Clinical characteristics of the 4 case-patients were consistent with those of naturally occurring botulism. All case-patients had been injected with a highly concentrated, unlicensed preparation of botulinum toxin A and may have received doses 2857 times the estimated human lethal dose by injection. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21 to 43 times the estimated human lethal dose; pretreatment serum from the fourth epidemiologically linked case-patient was not available. A 100-microg vial of toxin taken from the same manufacturer's lot as toxin administered to the case-patients contained a toxin amount sufficient to kill approximately 14,286 adults by injection if disseminated evenly.
  
  
  CONCLUSIONS
  These laboratory-confirmed cases of botulism demonstrate that clinical use of unlicensed botulinum toxin A can result in severe, life-threatening illness. Further education and regulation are needed to prevent the inappropriate marketing, sale, and clinical use of unlicensed botulinum toxin products.
authors.affiliation: Epidemic Intelligence Service, Division of Foodborne, Bacterial and Mycotic Diseases, National Center for Zoonotic, Vectorborne and Enteric Diseases, Centers for Disease Control and Prevention, Atlanta, Ga, USA. sindia4@hotmail.com
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Chertow
authors.forename: Esther T
authors.initials: ET
authors.lastname: Tan
authors.forename: Susan E
authors.initials: SE
authors.lastname: Maslanka
authors.forename: Joann
authors.initials: J
authors.lastname: Schulte
authors.forename: Eddy A
authors.initials: EA
authors.lastname: Bresnitz
authors.forename: Richard S
authors.initials: RS
authors.lastname: Weisman
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Bernstein
authors.forename: Steven M
authors.initials: SM
authors.lastname: Marcus
authors.forename: Savita
authors.initials: S
authors.lastname: Kumar
authors.forename: Jean
authors.initials: J
authors.lastname: Malecki
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sobel
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Braden
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000097:blood / Q000592:standards / Q000600:supply & distribution; D001906:Botulism / Q000097:blood / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D016000:Cluster Analysis; D003357:Cosmetic Techniques / Q000009:adverse effects* / Q000592:standards; D006801:Humans; D007049:Iatrogenic Disease / Q000453:epidemiology; D007880:Legislation, Drug; D007928:Lethal Dose 50; D014481:United States
chemical_list: D019274:Botulinum Toxins, Type A