Document Detail

Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation.
MedLine Citation:
PMID:  17119144     Owner:  NLM     Status:  MEDLINE    
CONTEXT: 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.
DESIGN, SETTING, AND PATIENTS: Case series on 4 botulism case-patients.
MAIN OUTCOME MEASURES: 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.
Daniel S Chertow; Esther T Tan; Susan E Maslanka; Joann Schulte; Eddy A Bresnitz; Richard S Weisman; Jeffrey Bernstein; Steven M Marcus; Savita Kumar; Jean Malecki; Jeremy Sobel; Christopher R Braden
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  JAMA     Volume:  296     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2006 Nov 
Date Detail:
Created Date:  2006-11-22     Completed Date:  2006-11-27     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2476-9     Citation Subset:  AIM; IM    
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MeSH Terms
Botulinum Toxins, Type A* / administration & dosage,  blood,  standards,  supply & distribution
Botulism / blood,  diagnosis,  epidemiology,  etiology*
Cluster Analysis
Cosmetic Techniques / adverse effects*,  standards
Iatrogenic Disease* / epidemiology
Legislation, Drug
Lethal Dose 50
United States
Reg. No./Substance:
EC Toxins, Type A

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