A Return from BOTOX to Botulism
By: T. Claire Frances
Date: July 10, 2014
Instructor: Linda Maywood, MSN, CPNP
Course Title: HIT 102 Pharmacology of Allied Health Professions
BOTOX, Dysport, Xeomin (onabotulinumtoxinA, BTX-A); BTX-B (Myobloc), BTX, BoNT, BTX A-G, C. Botulinum, botulinum toxin; and since 2013, BTX-H; These are all terms synonymous or derived from the most dangerous toxin known to humankind, Botulism. Botulism is the term used most often to describe the serotypes derived from Clostridium botulinum. C. botulinum it's purported, was first isolated as a bacterium by Belgium bacteriologist Emile Pierre van Ermengem in 1897. Botulism (Latin, botulus, meaning "sausage") was prior to coined by poet and physician Justinus Kerner who discovered the "sausage poison;" and who first theorized future therapeutic benefits of the toxic. (Kedlaya,2014).
BTX is found in the soil and survives in low oxygen environments; also found in animals as well as humans. Until 2013, the most potent form of BTX toxic was Botulism Type A. Type A and Type B are approved by the Food and Drug Administration (FDA) for cosmetic procedures; however, it does not pose the same risks as food-borne BTX. Controlled doses for therapeutic medicine are purified and diluted for aesthetic medicine, marketed as BOTOX. Up until 2013, seven major types of BTX were universally accepted serotypes, designated A through G, of which only A, B, E and F cause illness in humans. (Davis, 2014)
The growing popularity of Botulinum toxin, BTX-A is evident with common cosmetic procedure reportedly doubled up to 6.1 million procedures (up 8%) in 2012 according to the American Society of Plastic Surgeons (ASPS) (Reath, 2013). The FDA has approved BTX-A and BTX-B for cosmetic purposes. Although medical risks are much decreased with diluted forms of the neurotoxin, there are many side effects; even before any severe but rare incidence of BTX's spread to other parts of body. If injections aren't correctly placed, the BTX may spread into adjacent tissues producing symptoms such as eyelid droop, cockeyed eyebrows, crooked smile, dry eye or excessive tearing. (Mayo, 2013).
Botox is marketed in the United States by Allergan, Inc. Allergan's provides a 36 page safety sheet outlining the multitudinous side effects for the FDA approved uses of BTX-A, under brand names Dysport and Xeomin; and Type B, brand name Myobloc. Type A toxin was initially developed outside the U.S. (Europe, China, Germany and elsewhere); and type B, within the U.S. Therapeutic uses are extensive, ranging from eye treatments both cosmetic and corrective, to muscle injections for migraines and Cervical Dystonia. (Allergan, 2014)
Publications referencing the therapeutic efficacy of Botulinum toxin for medical purposes was by an ophthalmologist in 1980, Dr. Alan B. Scott, MD, for treatment of strabismus (cross eyes) in patients having researched BTX since the 1960s. (Felber). Botulinum toxin products have also been approved by FDA for one or more of the following uses: temporary improved appearance of glabellar lines (frown lines, eyebrows), strabismus, blepharospasm (abnormal eyelid tics and twitches), cervical dystonia (involuntary sustained or repetitive neck muscles contractions), and primary axillary hyperhidrosis (severe underarm sweating). For these uses, botulinum toxin is injected into the skin or muscle tissue. However, in a postmarketing review from 2009, the FDA reaffirmed its 2008 decision not to approve BTX for cerebral palsy, citing the possible side effect risks indicated plus, "Serious case reports described hospitalizations involving ventilatory support and reports of death." (FDA, 2009)
Cosmetic Botox is a heavily diluted and purified form of Clostridium botulinum and only available by prescription. It's administered to patients via injection; dispensed in a powder form in units of 50,100, or 200. BOTOX is reconstituted with sterile, non-preserved 0.9%...
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