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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).
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