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.