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Highly-Concentrated Botulinum Preparation Can Result in Severe Illness

An examination of 4 cases of botulism following cosmetic injections to the face indicates that the adults received a highly concentrated, //unlicensed preparation that resulted in toxin levels up to 40 times the estimated human lethal dose, according to a report.

Botulism is a rare paralytic illness caused by the toxins of the spore-forming bacterium Clostridium botulinum and toxin-producing strains of Clostridium baratii and Clostridium butyricum. Botulism, left untreated, may result in respiratory failure and death, according to background information in the article. Two botulinum toxin preparations are licensed in the United States by the U.S. Food and Drug Administration for clinical use, BOTOX (crystalline toxin type A); and Myobloc/Neurobloc (toxin type B). 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, four suspected botulism case-patients with a link to cosmetic botulinum toxin injections were reported to the Centers for Disease Control and Prevention.

Daniel S. Chertow, M.D., M.P.H., of the CDC, Atlanta, and colleagues investigated various aspects of the four suspected cases of botulism. They found that clinical characteristics of the four 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, intended for laboratory research, labeled accordingly, and not licensed or intended for human use.

Clinic staff had diluted a 100-μg vial of pure neurotoxin with diluent and drew up the resulting solution into syringes for clinical use. The physician working at the clinic administered 4 case-patients (including himself) 4 to 6 injections of this toxin solution in the facial area. All the patients eventually rep
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