WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX 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 SUMMARY
BOTOX (Botulinum Toxin Type A) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use.
Bladder Dysfunction
Overactive Bladder
BOTOX (onabotulinumtoxinA) for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Detrusor Overactivity associated with a Neurologic Condition
BOTOX is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Chronic Migraine
BOTOX is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).
Important limitations
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
Upper Limb Spasticity
BOTOX is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).
Important limitations
Safety and effectiveness of BOTOX have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity. Safety and effectiveness of BOTOX have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX is not intended to substitute for usual standard of care rehabilitation regimens.
Cervical Dystonia
BOTOX is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
Primary Axillary Hyperhidrosis
BOTOX is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
Important limitations
The safety and effectiveness of BOTOX for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of BOTOX have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
Blepharospasm and Strabismus
BOTOX is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
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NEWS HIGHLIGHTS
Published Studies Related to Botox (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 (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 (Botulinum Toxin Type A) Side Effects
Headache (14),
Dysphagia (14),
Vision Blurred (12),
Fatigue (10),
Eyelid Ptosis (10),
Dyspnoea (10),
Anxiety (10),
Muscular Weakness (9),
Respiratory Disorder (8),
Pyrexia (8), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 9 ratings/reviews, Botox has an overall score of 6.67. The effectiveness score is 9.11 and the side effect score is 6.89. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Botox review by 51 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | migraines |
| Dosage & duration: | | 1 vial (dosage frequency: every 3-6 months) for the period of five plus years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I used to have near-daily migraines. I tried every migraine medication on the market. Either they didn't have any effect, or I was unable to tolerate them due to side-effects. With Botox injections administered by a very knowledgable neurologist who is also a pain specialist, I am virtually migraine-free for months. |
| Side effects: | | Sometimes I had some minor swelling at an injection site. It went away within days. |
| Comments: | | My neurologist injects the tiny cranial muscles as well as muscles along my neck and upper shoulder. He uses a tiny needle and injects very little at each site. He determines where the trigger points are before administering the Botox. PLEASE NOTE: If using Botox for migraines, do go to a neurologist who is experienced with migraine pain. DO NOT have this done by a cosmetic surgeon! |
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| | Botox review by 42 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | wrinkles |
| Dosage & duration: | | 40 vials (dosage frequency: every 6 months) for the period of every 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Wrinkles did disapear, but there was bruising and swelling. It did reduce after a few days, and I noticed the inability to move the muscles in my forehead and around my mouth. |
| Side effects: | | Bruising and swelling. Not sure if it was the way the injections were delivered or because of my tendency to bruise. |
| Comments: | | The vials were injected around my mouth, eyes, and on the forhead. The effect did last for several months, but I had not been happy about the side effects. |
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| | Botox review by 44 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | cosmetic/frown lines |
| Dosage & duration: | | 50 units (dosage frequency: four different visits) for the period of two years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Did have elimination of frown lines and crows feet but no one cares about having wrinkles or not when you are paralyzed. Sadly wrinkles returned in 6 months but large nerves in my legs and and body continue to suffer daily with weakness several years later. Risks too great for some temporary cosmetic procedure |
| Side effects: | | Botulism. Permanent disability. Neuropathy, autonomic nerve injury. chronic myalgias. Chronic nerve pain
Chronic long term muscle weakness. Difficulty breathing, difficulty swallowing, blurry vision. Disabling muscle weakness. permanent paresthesias. |
| Comments: | | Injected by qualified personnel. National Botox trainer. Used 50 units total with a dilution of 1cc per 100 unit vial. injected with several sites at frown lines and crows feet. |
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Page last updated: 2015-08-10
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