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Highly concentrated botulinum preparation for cosmetic injections can result in severe illness

l the patients eventually reported symptoms of progressive weakness and cranial neuropathies (abnormality of the nerves that control a number of functions, including movement of the facial muscles and swallowing), with two patients experiencing shortness of breath.

The researchers report the patients may have received doses 2,857 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.

"Botulism is a potentially fatal disease, which invariably presents with acute bilateral cranial neuropathies, regardless of exposure mechanism. Early recognition of botulism, treatment in an intensive care setting, provision of mechanical ventilation when indicated, and rapid administration of antitoxin (optimally within 12 hours of presentation) have been associated with improved clinical outcome. Suspected cases of botulism should be reported immediately to local health authorities to facilitate rapid epidemiological investigation, provision of antitoxin when indicated, and prevention of further cases," the researchers write.

"Physicians and patients must be aware of the hazards associated with illegitimate use of unlicensed botulinum toxin products. Only licensed products should be used clinically. Entities inappropriately marketing, selling, or using unlicensed botulinum toxin products should be sought and subjected to full criminal and civil penalties. The Code of Federal Regulations should be modified to reduce the weight threshold of individual shipments subject to regulation and should require researchers to provide legal docum
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Source:JAMA and Archives Journals


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