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Botox (Botulinum Toxin Type A) - Summary

 
 



BOTOX SUMMARY

BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex 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. 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.

BOTOX® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

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.

The efficacy of BOTOX® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.


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NEWS HIGHLIGHTS

Media Articles Related to Botox (Botulinum Toxin Type A)

Botox, Fillers or Laser Treatments May Have Few Complications
Source: Medscape Dermatology Headlines [2014.11.14]
Side effects or complications were rare and usually temporary in a U.S. study of noninvasive or minimally-invasive cosmetic procedures.
Reuters Health Information

Improving the safety and efficacy of Botox injections
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2014.10.04]
New insights into botulinum neurotoxins and their interactions with cells are moving scientists ever closer to safer forms of Botox and a better understanding of the dangerous disease known as...

Botox Tested on Stomach Cancer in Mice
Source: MedicineNet Stomach Cancer Specialty [2014.08.21]
Title: Botox Tested on Stomach Cancer in Mice
Category: Health News
Created: 8/20/2014 4:36:00 PM
Last Editorial Review: 8/21/2014 12:00:00 AM

Botox Might Help Treat Bladder Disorders
Source: MedicineNet Botulism Specialty [2014.05.19]
Title: Botox Might Help Treat Bladder Disorders
Category: Health News
Created: 5/17/2014 12:35:00 PM
Last Editorial Review: 5/19/2014 12:00:00 AM

Botox to Treat Multiple Sclerosis (MS)
Source: MedicineNet Botulism Specialty [2014.04.30]
Title: Botox to Treat Multiple Sclerosis (MS)
Category: Procedures and Tests
Created: 1/31/2005 5:23:00 AM
Last Editorial Review: 4/30/2014 12:00:00 AM

more news >>

Published Studies Related to Botox (Botulinum Toxin Type A)

Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. [2012]
therapy are needed... CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection

Botulinum toxin effects on gasatrocnemius strength and plantar pressure in diabetics with peripheral neuropathy and forefoot ulceration. [2012]
gastrocnemius-soleus muscles to reduce muscle strength and plantar pressure... CONCLUSION: There were no adverse events associated with the Botox® injections.

Vandetanib: in medullary thyroid cancer. [2012]
Vandetanib, an orally active, small-molecule, multitargeted tyrosine kinase inhibitor, demonstrates potent inhibitory activity against vascular endothelial growth factor receptor (VEGFR)-2 and -3, epidermal growth factor receptor (EGFR) and the rearranged during transfection (RET) tyrosine kinase receptor...

Botulinum toxin a versus placebo for refractory detrusor overactivity in women: a randomised blinded placebo-controlled trial of 240 women (the RELAX study). [2012]
treatment of DO... CONCLUSIONS: This randomised controlled trial of BoNTA for refractory DO, the

Prospective randomized comparison of onabotulinumtoxinA (Botox) and abobotulinumtoxinA (Dysport) in the treatment of forehead, glabellar, and periorbital wrinkles. [2012]
California) and abobotulinumtoxinA (BoNT-ABO; Dysport, Ipsen Ltd, Slough, UK)... CONCLUSIONS: At the current pricing of the agents, BoNT-ABO offers a significant

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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 Cosmetic™ 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.

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Page last updated: 2014-11-14

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