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Botulism in 4
Adults Following Cosmetic Injections With an Unlicensed, Highly
Concentrated Botulinum Preparation
Daniel S. Chertow, MD, MPH; Esther T.
Tan, MBBS, MPH; Susan E. Maslanka, PhD; Joann Schulte, DO, MPH; Eddy A.
Bresnitz, MD, MS; Richard S. Weisman, PharmD; Jeffrey Bernstein, MD; Steven
M. Marcus, MD; Savita Kumar, MD, MSPH; Jean Malecki, MD, MPH; Jeremy Sobel,
MD, MPH; Christopher R. Braden, MD
JAMA. 2006;296:2476-2479.
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-µg 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.
Author Affiliations: Epidemic Intelligence Service (Drs Chertow and
Tan), Division of Foodborne, Bacterial and Mycotic Diseases, National Center
for Zoonotic, Vectorborne and Enteric Diseases (Drs Maslanka, Sobel, and
Braden), Centers for Disease Control and Prevention, Atlanta, Ga; Division
of Disease Control, Florida Department of Health, Tallahassee (Drs Chertow
and Schulte); Division of Epidemiology, Environmental and Occupational
Health, State of New Jersey Department of Health and Senior Services,
Trenton (Drs Tan and Bresnitz); Miller School of Medicine, University of
Miami, Miami, Fla (Drs Weisman and Bernstein); Florida Poison Information
Center, Miami (Drs Weisman and Bernstein); University of Medicine and
Dentistry of New Jersey, and the New Jersey Poison Information and
Education System, Newark (Dr Marcus); Division of Epidemiology and Disease
Control, Palm Beach County Health Department, Florida Department of Health,
West Palm Beach (Dr Kumar); Director, Palm Beach County Health Department,
Florida Department of Health, West Palm Beach (Dr Malecki).
JAMA. 2006;296:2411.
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