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Botox (Botulinum Toxin Type A) - Summary

 
 



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]

 

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.


See all Botox indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Botox (Botulinum Toxin Type A)

Botox boosts pliability, elasticity of skin for up to 4 months
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2015.05.24]
A new study finds botox - a drug commonly used to reduce the appearance of facial wrinkles - increases the pliability and elasticity of skin for up to 4 months after treatment.

Does Botox Actually Rejuvenate Skin?
Source: MedicineNet Botulism Specialty [2015.05.22]
Title: Does Botox Actually Rejuvenate Skin?
Category: Health News
Created: 5/21/2015 12:00:00 AM
Last Editorial Review: 5/22/2015 12:00:00 AM

Botox Eases Overactive Bladder, 2 Studies Find
Source: MedicineNet Overactive Bladder Specialty [2015.05.18]
Title: Botox Eases Overactive Bladder, 2 Studies Find
Category: Health News
Created: 5/15/2015 12:00:00 AM
Last Editorial Review: 5/18/2015 12:00:00 AM

Botox: An Rx for Irregular Heartbeat After Cardiac Surgery?
Source: MedicineNet Coronary Artery Bypass Graft Specialty [2015.05.15]
Title: Botox: An Rx for Irregular Heartbeat After Cardiac Surgery?
Category: Health News
Created: 5/14/2015 12:00:00 AM
Last Editorial Review: 5/15/2015 12:00:00 AM

Beyond the wrinkles: Botulinum toxin A and its innovative treatment for bladder disorders
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2015.05.18]
While Botulinum toxin A (BTX-A), known to the public as Botox®, is commonly associated with smoothing wrinkles for a more youthful appearance, three studies presented at the 110th Annual...

more news >>

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

more studies >>

Clinical Trials Related to Botox (Botulinum Toxin Type A)

Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm [Completed]
To compare the efficacy and safety of Korean botulinum toxin A (KbtxA, Pacific Pharmaceuticals, Korea) against Botox in the treatment of essential blepharospasm, we performed a double-blinded, randomized, comparative trial comparing KbtxA and Botox for treatment of blepharospasm in 60 patients of the intention to treat population and 52 patients (26 patients from each group) of the per protocol population. The improvement of severity of spasm (SS) at 4 weeks post-injection as a primary efficacy outcome, qualifying non inferiority to the control group, Changes in eyelid closure force (CF) and functional visual status (FVS) after injection for secondary efficacy outcomes, and adverse effects for safety evaluation. Improvement of SS was noted in 90. 3% of the KbtxA group and 86. 2% of the Botox group. There were no significant differences between treatment groups in the changes of CF and FVS after injection (p>0. 05). Adverse effects developed in 16. 1% of the KbtxA group and 27. 6% of the Botox group, but no serious adverse events were found in either group. KbtxA was not inferior to Botox in treatment efficacy and was clinically safe with no serious adverse effects when used to treat essential blepharospasm.

Comparative Study of the Effect of Dysport and Botox [Completed]
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.

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.

Study to Determine If the Volume Used to Dilute BOTOX Cosmeticâ„¢ for Injection Affects Its Overall Effect and Duration. [Completed]
It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.

The study was designed to test this thinking, using the crow's feet wrinkles as the treatment area.

Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome [Completed]
The main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a type of back pain called primary myofascial pain syndrome.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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!

 

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.

 

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.

See all Botox reviews / ratings >>

Page last updated: 2015-08-10

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