Botulinum Toxin (Botox)

Botulinum Toxin (Botox) From Wikipedia, the free encyclopedia. 

Chemical Formula: C6760H10447N1743O2010S32 

Mol.Mass: 149.322,3223 kDa

SSTattler: This is a long article and I included a sub-set for stroke survivors.

Botulinum toxin is a protein and neurotoxin produced by the bacterium Clostridium botulinum. It is the most acutely toxic substance known, with an estimated human median lethal dose of 1.3–2.1 ng/kg intravenously or intramuscularly and 10–13 ng/kg when inhaled. Botulinum toxin can cause botulism, a serious and life-threatening illness in humans and animals. Popularly known by one of its trade names, Botox, it is used for various cosmetic and medical procedures.

History

Justinus Kerner described botulinum toxin as a "sausage poison" and "fatty poison", because the bacterium that produces the toxin often caused poisoning by growing in improperly handled or prepared meat products. It was Kerner, a physician, who first conceived a possible therapeutic use of botulinum toxin and coined the name botulism (from Latin botulus meaning "sausage"). In 1897, Emile van Ermengem found the producer of the botulin toxin was a bacterium, which he named Clostridium botulinum. In 1928, P. Tessmer Snipe and Hermann Sommer for the first time purified the toxin. In 1949, Arnold Burgen's group discovered, through an elegant experiment, that botulinum toxin blocks neuromuscular transmission through decreased acetylcholine release.

Therapeutic Research

In the late 1960s, Alan Scott, MD, a San Francisco ophthalmologist, and Edward Schantz were the first to work on a standardized botulinum toxin preparation for therapeutic purposes. By 1973, Scott (now at Smith-Kettlewell Institute) used botulinum toxin type A (BTX-A) in monkey experiments, and, in 1980, he officially used BTX-A for the first time in humans to treat "crossed eyes" (strabismus), a condition in which the eyes are not properly aligned with each other, and "uncontrollable blinking" (blepharospasm). In 1993, Pasricha and colleagues showed botulinum toxin could be used for the treatment of achalasia, a spasm of the lower esophageal sphincter. In 1994, Bushara showed botulinum toxin injections inhibit sweating. This was the first demonstration of non-muscular use of BTX-A in humans.

Blepharospasm and Strabismus

In the early 1980s, university-based ophthalmologists in the USA and Canada further refined the use of botulinum toxin as a therapeutic agent. By 1985, a scientific protocol of injection sites and dosage had been empirically determined for treatment of blepharospasm and strabismus. Side effects were deemed to be rare, mild and treatable. The beneficial effects of the injection lasted only 4–6 months. Thus, blepharospasm patients required re-injection two or three times a year. In 1986, Scott's micromanufacturer and distributor of Botox was no longer able to supply the drug because of an inability to obtain product liability insurance. Patients became desperate, as supplies of Botox were gradually consumed, forcing him to abandon patients who would have been due for their next injection. For a period of four months, American blepharospasm patients had to arrange to have their injections performed by participating doctors at Canadian eye centers until the liability issues could be resolved.

The global botox market is forecast to reach $2.9 billion by 2018. The entire global market for facial aesthetics is forecast to reach $4.7 billion in 2018, of which the US is expected to contribute over $2 billion. In December 1989, Botox, manufactured by Allergan, Inc., was approved by the US Food and Drug Administration (FDA) for the treatment of strabismus, blepharospasm, and hemifacial spasm in patients over 12 years old.

Upper Motor Neuron Syndrome

BTX-A is now a common treatment for muscles affected by the upper motor neuron syndrome (UMNS), such as cerebral palsy, for muscles with an impaired ability to effectively lengthen. Muscles affected by UMNS frequently are limited by weakness, loss of reciprocal inhibition, decreased movement control and hypertonicity (including spasticity). Joint motion may be restricted by severe muscle imbalance related to the syndrome, when some muscles are markedly hypertonic, and lack effective active lengthening. Injecting an overactive muscle to decrease its level of contraction can allow improved reciprocal motion, so improved ability to move and exercise. In June 2009, its use for treating hypertonic muscles helped an Australian man to walk again. He had required a wheelchair for mobility following a stroke 20 years prior.

Sources

Botulism toxins are produced by the bacteria Clostridium botulinum, C. butyricum, C. baratii and C. argentinense. Foodborne botulism can be transmitted through food that has not been heated correctly prior to being canned or food that was not cooked correctly from a can. Most infant botulism cases cannot be prevented because the bacteria that cause this disease are in soil and dust. The bacteria can be found inside homes on floors, carpet, and countertops even after cleaning. Honey can contain the bacteria that cause infant botulism, so children less than 12 months old should not be fed honey. Honey is safe for persons one year of age and older.

Food-borne botulism usually results from ingestion of food that has become contaminated with spores (such as a perforated can) in an anaerobic environment, allowing the spores to germinate and grow. The growing (vegetative) bacteria produce toxin. It is the ingestion of toxin that causes botulism, not the ingestion of the spores or the vegetative bacteria. Infant and wound botulism both result from infection with spores, which subsequently germinate, resulting in production of toxin and the symptoms of botulism.

Proper refrigeration at temperatures below 3°C (38°F) retards the growth of Clostridium botulinum. The organism is also susceptible to high salt, high oxygen, and low pH levels. The toxin itself is rapidly destroyed by heat, such as in thorough cooking. The spores that produce the toxin are heat-tolerant and will survive boiling water for an extended period of time.

Botulinum toxin can be absorbed from eyes, mucous membranes, respiratory tract or non-intact skin.

Botulinum toxin has been recognized and feared as a potential bioterror weapon.

Medical and Cosmetic Uses

Although botulinum toxin is a lethal, naturally occurring substance, it can be used as an effective and powerful medication. Researchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity by blocking the release of acetylcholine from the neuron by preventing the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. This will effectively weaken the muscle for a period of three to four months.

In cosmetic applications, a Botox injection, consisting of a small dose of botulinum toxin, can be used to prevent development of wrinkles by paralyzing facial muscles. As of 2007, it is the most common cosmetic operation, with 4.6 million procedures in the United States, according to the American Society of Plastic Surgeons. Qualifications for Botox injectors vary by county, state and country. Botox cosmetic providers include dermatologists, plastic surgeons, aesthetic spa physicians, dentists, nurse practitioners, nurses and physician assistants. The wrinkle-preventing effect of Botox normally lasts about three to four months, but can last up to six months.

In addition to its cosmetic applications, Botox is currently used in the treatment of spasms and dystonias, by weakening involved muscles, for the 60–70 day effective period of the drug. The main conditions treated with botulinum toxin are:

• Cervical dystonia (spasmodic torticollis) (a neuromuscular disorder involving the head and neck)
• Blepharospasm (excessive blinking) 
• Severe primary axillary hyperhidrosis (excessive sweating)
• Strabismus (squints) 
• Achalasia (failure of the lower oesophageal sphincter to relax) 
• Local intradermal injection of BTX-A is helpful in chronic focal neuropathies. The analgesic effects are not dependent on changes in muscle tone.
• Migraine and other headache disorders, although the evidence is conflicting in this indication Other uses of botulinum toxin type A that are widely known but not specifically approved by the FDA (off-label uses) include treatment of: * Idiopathic and neurogenic detrusor overactivity.
• Pediatric incontinence, incontinence due to overactive bladder, and incontinence due to neurogenic bladder 
• Anal fissure 
• Vaginismus to reduce the spasm of the vaginal muscles 
• Movement disorders associated with injury or disease of the central nervous system, including trauma, stroke, multiple sclerosis, Parkinson's disease, or cerebral palsy 
• Focal dystonias affecting the limbs, face, jaw, or vocal cords 
• Temporomandibular joint pain disorders 
• Diabetic neuropathy 
• Wound healing 
• Excessive salivation 
• Vocal cord dysfunction, including spasmodic dysphonia and tremor 
• Reduction of the masseter muscle for decreasing the apparent size of the lower jaw 
• Painful bladder syndrome 
• Detrusor sphincter dyssynergia and benign prostatic hyperplasia 
• Treatment and prevention of chronic headache and chronic musculoskeletal pain are emerging uses for botulinum toxin type A. In addition, Botox may aid in weight loss by increasing the gastric emptying time.

Manufacturers

In the United States, Botox is manufactured by Allergan, Inc. for both therapeutic and cosmetic use (100-unit). In 2011, Allergan required less than one gram of raw botulinum toxin neurotoxin to "supply the world's requirements for 25 indications approved by Government agencies around the world".

In the United States, Xeomin (manufactured in Germany by Merz) is available for both therapeutic and cosmetic use. Dysport, a therapeutic formulation of the type A toxin developed and manufactured in Ireland, is licensed for the treatment of focal dystonias and certain cosmetic uses in the US and worldwide in 100-, 300- and 500-unit packagess. Lanzhou Institute of Biological Products in China manufactures a BTX-A product, producing 50-unit and 100-unit type A toxin. Neuronox, a BTX-A product, was introduced by Medy-Tox Inc. of South Korea, in 2009. In America, Neuronox is also known as Siax. Merz manufactures the toxin and sells it under the trade name Xeomin. Solstice Neurosciences, LLC, a wholly owned subsidiary of US WorldMeds, LLC sells their product under the names Myobloc or Neurobloc, although it contains botulinum toxin type B, not the common type A found in Botox.

See the full article Botulinum Toxin (Botox) 

         From Wikipedia, the free encyclopedia. 

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Dr. Kenneth Ngo, Brain Injury Program Medical Director talks about the new spasticity management clinic being developed at Brooks Rehabilitation. Spasticity is a condition commonly seen in those who have had a stroke, spinal cord injury, brain injury, or are living with cerebral palsy or multiple sclerosis. Spasticity typically affects the limbs and causes them to be tight. The goal of the spasticity management clinic is to losen the limbs and improve function and quality of life. Treatments include physical therapy, occupational therapy as well as botox or implantable devices. Learn more about the spasticity management clinic at Brooks Rehabilitation.

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Botox, most commonly known as a cosmetic drug, could also help in brain recovery for patients who suffer a stroke. See more at tennews.com.au


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Physiatrist M.D. Helps Stroke Victim Walk Again

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Botox Helps Stroke Victims

When many people think about Botox, they may imagine injections to erase wrinkles. But Botox has much more serious and life-changing uses for stroke patients and others with neurological conditions.


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Botox for Stroke Victims

Henry Winkler and The Doctors explain how Botox can help those who have suffered a stroke.


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Botox for Stroke Patients

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Botox for Post-Stroke Spasticity

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Botox Injections for Stroke & Spasticity Recovery

Sarah Abrusley discusses her recovery from a 2007 stroke and how Botox injections have relaxed the muscle tone and spasticity she was suffering in her left arm and hand. She is under the care of Dr. Andrea Toomer of Culicchia Neurological Clinic in New Orleans. culicchianeuro.com


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Botox® for Urinary Incontinence

Dr. Paige White, Memorial Urologist, discusses an alternative treatment for urinary incontinence.


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Early Communication on Adverse Events from Botox and Myobloc

FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product was used, and not to a defect in the manufacturing process. The events occurred one day to several weeks after treatment, and from a wide range of dosages.

In the affected patients, the botulinum toxin may have spread beyond the injection site and caused symptoms associated with botulism, including dysphagia and respiratory insufficiency. The most severe effects were seen in children, and the most commonly reported use in children was for limb spasticity in cerebral palsy, which is an unapproved use. Adverse reactions also occurred in patients receiving the drug for approved indications.

FDA is evaluating all the adverse event reports, as well as the medical literature in this area, and will let health professionals and the public know about any new information or conclusions.

In the meantime, healthcare professionals who use botulinum toxins should be alert to the potential for systemic effects from local injections, including dysphagia, dysphonia, weakness, dyspnea, or respiratory distress. They should tell patients and caregivers about the symptoms of botulism and to seek immediate medical attention if they occur.

Finally, practitioners should understand that the potency of botulinum toxin, which is expressed in "Units" ("U"), is not comparable from one botulinum toxin product to the next.


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