The safe and effective use of BOTOX depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. An understanding of standard electromyographic techniques is also required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia. Physicians administering BOTOX must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease, especially when injecting near the lungs.
Two years later, Allergan bought Oculinum for $9 million and changed the drug's name to Botox. At the time, Allergan was primarily an ocular-care company that sold products like contact-lens cleaners and prescription solutions for dry eyes, bringing in about $500 million in annual sales. Allergan says it saw Botox as a drug for a niche population: it's estimated that 4% of people in the U.S. have crossed eyes, for which the drug was initially approved, and Allergan made about $13 million in sales from the drug by the end of 1991.
Since then, several randomized control trials have shown botulinum toxin type A to improve headache symptoms and quality of life when used prophylactically for patients with chronic migraine[88] who exhibit headache characteristics consistent with: pressure perceived from outside source, shorter total duration of chronic migraines (<30 years), "detoxification" of patients with coexisting chronic daily headache due to medication overuse, and no current history of other preventive headache medications.[89]
The most frequently reported adverse reactions following injection of BOTOX® for Chronic Migraine vs placebo include, respectively: neck pain (9% vs 3%), headache (5% vs 3%), eyelid ptosis (4% vs < 1%), migraine (4% vs 3%), muscular weakness (4% vs < 1%), musculoskeletal stiffness (4% vs 1%), bronchitis (3% vs 2%), injection-site pain (3% vs 2%), musculoskeletal pain (3% vs 1%), myalgia (3% vs 1%), facial paresis (2% vs 0%), hypertension (2% vs 1%), and muscle spasms (2% vs 1%).
The trapezius muscle is a large, triangular, superficial muscle. It attaches proximally in the medial third of the superior nuchal line, external occipital protuberance, nuchal ligament, and spinous processes of the C7-T12 vertebrae. Distal attachment of the trapezius occurs at the lateral third of the clavicle and acromion and spine of the scapula. The action of the muscle includes neck extension and stabilization of the scapula and support for the arm. The muscle fibers proximal to the inflection point of the neck (ie, necklace line) run vertically and are involved with neck extension. According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA to each of three sites on either side of the trapezius, for a total of 30 units divided across six sites, is given. The first injection site can be identified by visually dividing the upper portion of the trapezius muscle in half, from the inflection point of the neck (ie the necklace line) to the acromion (acromio-clavicular joint); the midpoint of this location is where the injection should be administered. The second injection is located at the midpoint of the first injection site and the acromion. The third injection should be administered at the midpoint between the first injection site and the necklace line. Injections should occur in the supraclavicular portion of the muscle, lateral to the neckline, and medial to the deltoid and the acromio-clavicular joint. The injections into the trapezius should be administered horizontally and superficially to avoid injecting too deep.

That’s enough to generate buzz on the patient forums like RealSelf among those who have tried it: “My neck is killing me” wrote one user;  I’ve got “Stiffness, pain in the neck, headache and can’t look down” reported another. Like anything, results vary widely. “I have since felt nauseous and dizzy on and off every day, as well as have blurry vision.
In November, the FDA held a two-day hearing asking for expert comment on the agency's rules concerning off-label drug use and marketing. Some said the practice paves the way for scientific progress and gives doctors and their patients much needed alternatives for hard-to-treat medical conditions. Others said that off-label drug use is primarily financially motivated and that it poses a serious threat to public health, particularly when drugs are used experimentally on children.
Jump up ^ van Ermengem E (1979). "Classics in infectious diseases. A new anaerobic bacillus and its relation to botulism. E. van Ermengem. Originally published as "Ueber einen neuen anaëroben Bacillus und seine Beziehungen zum Botulismus" in Zeitschrift für Hygiene und Infektionskrankheiten 26: 1–56, 1897". Reviews of Infectious Diseases (in German). 1 (4): 701–19. PMID 399378. Original doi:10.1007/BF02220526
Ray Chester, an attorney in Austin who has represented several plaintiffs in lawsuits against Allergan, says that just about all the cases he has handled involved off-label use of the drug. In 2014 a New York couple argued that Botox, which they chose to try off-label to treat their son's cerebral-palsy symptoms, caused life-threatening complications. The family was awarded $6.75 million by a jury. Allergan, which initially planned to appeal, ended up privately settling the case with the family, and the terms of the settlement have been kept confidential.

Jump up ^ van Ermengem E (1979). "Classics in infectious diseases. A new anaerobic bacillus and its relation to botulism. E. van Ermengem. Originally published as "Ueber einen neuen anaëroben Bacillus und seine Beziehungen zum Botulismus" in Zeitschrift für Hygiene und Infektionskrankheiten 26: 1–56, 1897". Reviews of Infectious Diseases (in German). 1 (4): 701–19. PMID 399378. Original doi:10.1007/BF02220526
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
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