WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
[See Warnings and Precautions]
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BOTOX COSMETIC SUMMARY
BOTOX ® Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. One Unit of BOTOX ® Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. The method utilized for performing the assay is specific to Allergan's product BOTOX ® Cosmetic. Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for the various mouse LD50 assays, Units of biological activity of BOTOX ® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. In addition, differences in species sensitivities to different botulinum neurotoxin serotypes precludes extrapolation of animal-dose activity relationships to human dose estimates. The specific activity of BOTOX ® Cosmetic is approximately 20 Units/nanogram of neurotoxin protein complex. Each vial of BOTOX ® Cosmetic contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride or 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
BOTOX ® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age or less.
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NEWS HIGHLIGHTS
Published Studies Related to Botox Cosmetic (Botulinum Toxin Type A)
A Prospective, Split-Face, Randomized, Double-Blind Study Comparing
OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles. [2015]
wrinkles using a 1:1 dose ratio... CONCLUSIONS: For identical dosage, both onabotulinumtoxinA and
The efficacy and safety of liquid-type botulinum toxin type A for the management
of moderate to severe glabellar frown lines. [2015]
lines... CONCLUSIONS: The efficacy and safety of MT10109L were comparable to those of
The early use of botulinum toxin in post-stroke spasticity: study protocol for a
randomised controlled trial. [2014]
BACKGROUND: Patients surviving stroke but who have significant impairment of
function in the affected arm are at more risk of developing pain, stiffness and
contractures. The abnormal muscle activity, associated with post-stroke
spasticity, is thought to be causally associated with the development of these
complications...
Correlation of botulinum toxin dose with neurophysiological parameters of
efficacy and safety in the glabellar muscles: a double-blind, placebo-controlled,
randomized study. [2014]
Despite the extensive use of botulinum toxin type A (BoNT-A) in treatments for
glabellar frown lines, the dose-response effect in the glabellar muscles remains
unknown. The aim of this randomized, double-blind, placebo-controlled prospective
study was to characterize the neurophysiological parameters that correlate with
the effect of BoNT-A in the glabellar muscles and its diffusion to surrounding
ocular muscles...
Botulinum toxin type A potentiates the effect of neuromotor rehabilitation of
Pisa syndrome in Parkinson disease: a placebo controlled study. [2014]
group of PD patients with PS... CONCLUSIONS: Our preliminary data suggest that BT may be considered an important
Clinical Trials Related to Botox Cosmetic (Botulinum Toxin Type A)
Pilot Study of BOTOX for Migraine Headaches [Terminated]
The purposes of this study are to assess whether subjects treated with BOTOX will:
1. have a decrease in the frequency and intensity of migraine headaches
2. experience improvements in quality of life
3. experience a reduction in the frequency of health care services obtained.
Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI [Recruiting]
The purpose of this study is to investigate the impact of 200 U intradetrusor injected
OnabotulinumtoxinA (Botox, Allergan, Inc.) (20 sites, trigone sparing) for neurogenic
detrusor overactivity (NDO) and its role on reducing autonomic dysreflexia (AD) in those
with chronic, traumatic spinal cord injury (SCI). In clinical practice, urinary bladder
dysfunctions are commonly associated with episodes of AD. If AD is misdiagnosed or poorly
managed, it may result in myocardial infarction,stroke, seizure, intracerebral hemorrhaging
or even death. Reducing AD would dramatically improve the health and well-being of Canadians
with SCI, and positively impact health care costs. There are an estimated 7,343 hospital
re-admissions due to SCI-related conditions in Canada every year, with an estimated 5-year
cost of $661 million. Reducing hospital re-admissions for secondary complications of SCI by
only 10% over this time period could result in a costs savings of $66 million for Canada.
Considering these statistics, the present study could be a first attempt to evaluate the
economic impact of using Botox to manage the urinary bladder following SCI. We will be able
to examine its impact on episodes of AD and consequently calculate the cost saving for the
Canadian health system. A significant number of individuals with SCI will require frequent
emergency room visits due to episodes of uncontrolled AD that originate predominately from
the urinary bladder. There is clinical evidence demonstrating that costs of bladder
management following SCI will depend on the understanding of the volumes that the urinary
bladder can safely hold. This is one of the positive outcomes that have been established in
previous trials of Botox therapy for the neurogenic bladder.
Hypothesis: 200 U of intradetrusor injected Botox (20 sites, trigone sparing) for
neurogenic bladder detrusor hyperreflexia will decrease the severity of AD in individuals
with SCI one month following treatment.
ASIS for Botox in Cervical Dystonia [Not yet recruiting]
Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they
are typically injected. All nerves terminate on the fascia, where ASIS device can precisely
deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus
enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse
reactions and distant spread, especially since Botox has no reason to travel to the rest of
the body any way.
ASIS for Botox in Upper Limb Spasticity [Not yet recruiting]
Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are
typically injected. All nerves terminate on the fascia, where ASIS device can precisely
deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus
enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse
reactions and distant spread, especially since Botox has no reason to travel to the rest of
the body any way.
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures [Active, not recruiting]
The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at
the time of surgery for pilon fractures, will improve ankle range-of-motion and
functionality.
Reports of Suspected Botox Cosmetic (Botulinum Toxin Type A) Side Effects
Drug Ineffective (1232),
Therapeutic Response Decreased (381),
Wrong Technique in Drug Usage Process (308),
Eyelid Ptosis (206),
Injection Site Pain (138),
Headache (123),
Facial Paresis (78),
Vision Blurred (59),
Swelling Face (57),
Injection Site Swelling (49), more >>
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Page last updated: 2015-08-10
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