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BAT is the only FDA-approved product available for treating botulism in adults, and for botulism in infants caused by botulinum toxins other than types A and B. BAT has been used to treat a case of type F infant botulism and, on a case-by-case basis, may be used for future cases of non-type A and non-type B infant botulism.
Botulinum toxin, or botulinum neurotoxin (commonly called botox), is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. [24] It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction , thus causing flaccid paralysis . [ 25 ]
Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. [1] [2] [3] The company is the maker of Botox. [1]
Along with some strains of Clostridium butyricum and Clostridium baratii, these bacteria all produce the toxin. [2] Botulinum toxin can cause botulism, a severe flaccid paralytic disease in humans and other animals, [3] and is the most potent toxin known to science, natural or synthetic, with a lethal dose of 1.3–2.1 ng/kg in humans. [4] [5]
This generally only occurs with inappropriate strengths of botulinum toxin for cosmetic use or due to the larger doses used to treat movement disorders. [2] However, there are cases where an off-label use of botulinum toxin resulted in severe botulism and death. [25] Following a 2008 review the FDA added these concerns as a boxed warning. [26]
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Clostridium botulinum can produce botulinum toxin in food or wounds and can cause botulism. This same toxin is known as Botox and is used in cosmetic surgery to paralyze facial muscles to reduce the signs of aging; it also has numerous other therapeutic uses.
Torticollis patients discovered that their pain could be markedly reduced, motility increased, and head position improved by toxin injection. But, in 1986, Oculinum Inc, Scott's micromanufacturer and distributor of botulinum toxin, was unable to obtain product liability insurance, and could no longer supply the drug.