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, blurred vision, 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 underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.
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.
Published Studies Related to Botox Cosmetic (Botulinum Toxin Type A)
The early use of botulinum toxin in post-stroke spasticity: study protocol for a
randomised controlled trial. 
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
Correlation of botulinum toxin dose with neurophysiological parameters of
efficacy and safety in the glabellar muscles: a double-blind, placebo-controlled,
randomized study. 
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
Safety and efficacy of botulinum toxin in primary orthostatic tremor. 
Primary orthostatic tremor (POT) is a rapid 13-18 Hertz tremor that produces a
subjective feeling of unsteadiness when standing, and is absent when seated or
supine. It predominantly affects the legs during isometric contraction though a
similar tremor can be seen in the arms and jaw...
OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled
subgroup analysis of patients who had acute headache medication overuse at
Acute headache medication overuse (MO) is common in patients with chronic
migraine (CM). We evaluated safety and efficacy of onabotulinumtoxinA as
preventive treatment of headache in CM patients with baseline MO (CM+MO) in a
planned secondary analysis from two similarly designed, randomized,
placebo-controlled, parallel, Phase III trials.
Upper extremity spasticity in children with cerebral palsy: a randomized,
double-blind, placebo-controlled study of the short-term outcomes of treatment
with botulinum A toxin. 
varying levels of function... CONCLUSIONS: Children receiving BoNT-A injections demonstrated clinically
Clinical Trials Related to Botox Cosmetic (Botulinum Toxin Type A)
Over Active Bladder Instillation Study - Botox [Recruiting]
The purpose of this study is to determine whether women with overactive bladder (OAB) who
receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl
Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms
when compared to a similar group of women with OAB who receive instillation of DMSO only.
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis [Not yet recruiting]
The primary purpose is to investigate the effect of Botox on the treatment of congenital
muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be
an effective treatment when used in conjunction with current treatment procedures.
The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke [Recruiting]
The purpose of this study is to see whether treating subjects for wrist rehabilitation
following stroke with Botox® and robotic therapy is more effective than treatment with
robotic therapy alone and no Botox®.
Evaluation of Quality of Life and Self-steem After Botox® in Depressed and Non-depressed Patients [Recruiting]
A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot [Recruiting]
The purpose of this study is to continue the work from the previous review study and
determine the effectiveness of Botox in treating patients with idiopathic clubfoot by
comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment
group) to those treated with manipulation and casting plus placebo (control group).
The null hypothesis is that manipulation and casting plus Botox is not an effective
treatment for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting
plus Botox is an effective treatment for idiopathic clubfoot.
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),
Facial Paresis (78),
Vision Blurred (59),
Swelling Face (57),
Injection Site Swelling (49), more >>
Page last updated: 2014-11-30