Botox - Botulinum Toxin

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Modified on 2009/10/14 21:53 by admin
Botox and Botox Cosmetic are both names for a purified neurotoxin protein complex derived from fermentation of the bacterium Clostridium botulinum type A and B.  The botulinum toxin protein complex, once collected, is then purified and suspended in sterile sodium chloride solution and albumin for clinical use.   

 
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Source: FDA 

There are both clinical and cosmetic applications for Botox, which is manufactured by Allergan and Solstice Neurosciences.  Solstice Neurosciences manufactures Botulinum toxin type B under the prescription brand name Myobloc. Botox was first approved by the FDA in 1989 to treat eye muscle disorders, and ultimately received approval in 2002 for the broad-based cosmetic application for which the drug is recognized today.  

Since the drug was first approved by the FDA, the botulinum toxin has been applied to patients suffering from cerebral palsy and Bell ’s palsy.  Physicians inject a unit of the botulinum toxin protein complex into the applied area, typically the face.  The toxin works by blocking the release of acetylcholine from nerve cells.  Acetylcholine is responsible for stimulating muscle contraction.  The paralysis of facial muscles from botox is not permanent, but rather lasts for three to six months.  Patients must be reinjected with the drug to maintain the look achieved through Botox injection.

In addition to being used to prevent wrinkles, Botox is also used to treat several health problems, including headaches, backaches and excessive sweating.  NIH studies are also exploring the use of Botox for the treatment of overactive bladder.

Botox Advisory Information

Botox is known for causing bruising, redness and pain at the site of injection. The toxin can also cause headaches, nausea, and flu-like symptoms.  In extreme situations, botox injections can migrate beyond the designated treatment area, causing symptoms of botulism.  These symptoms include slurred speech, droopy eyelids, and in severe cases, difficulty breathing.  

Patients who receive botox treatments for wrinkles are advised not to massage or rub their face after the procedure.  Rubbing the face after a botox procedure may cause the toxin to travel to other parts of the face unintended for treatment.

Botox History

2008

In February 2008, the FDA announced a safety review of Botox after a review of several adverse events reports detailed that botulinum toxin products had been linked to several cases of respiratory failure and death.  While the cases involved both FDA-approved and unapproved uses of Botox, the most serious cases involved child patients with cerebral palsy treated for spasticity.  Adverse effects reported were identical to the symptoms of botulism, and involved cases where the toxin had migrated from the original injection site.  The FDA also reported that some of the cases may be due to overdosing.

2002

The FDA granted approval for the use of Botox in cosmetic applications in April 2002.  Studies of the toxin had previously reviewed the drug’s application primarily to treat a neurological movement disorder causing shoulder and neck muscle contractions. 

1989

Botox was first approved in 1989 by the FDA to treat certain eye muscle disorders – strabismus and blepharospasm.  Clinical trials were undertaken to evaluate the toxin’s efficacy for other applications.

Drug Injury

Please consult with your physician about any questions you may have concerning Botox or any of its applications. If you are experiencing any of the side effects or symptoms from Botox misapplication or overdose, it may be important for you to speak to your physician about these side effects. 

If you have legal questions or believe that you have been injured as a result of Botox, you should contact an attorney who has experience in this area of practice.

IMPORTANT - You should never stop taking any medication without first consulting with your prescribing physician. 

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