BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP -25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle act ivity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX.
The efficacy and safety of BOTOX for the treatment of lower limb spasticity was evaluated in Study 6, a randomized, multi-center, double-blind, placebo-controlled study. Study 6 included 468 post-stroke patients (233 BOTOX and 235 placebo) with ankle spasticity (modified Ashworth Scale ankle score of at least 3) who were at least 3 months post-stroke. A total dose of 300 Units of BOTOX or placebo were injected intramuscularly and divided between the gastrocnemius, soleus, and tibialis posterior, with optional injection into the flexor hallucis longus, flexor digitorum longus, flexor digitorum brevis, extensor hallucis, and rectus femoris (see Table 33) with up to an additional 100 Units (400 Units total dose). The use of electromyographic guidance or nerve stimulation was required to assist in proper muscle localization for injections. Patients were followed for 12 weeks.
Botox takes three to five days to kick in, with the full effect becoming apparent within two weeks. Some people say they know when it’s taken effect because it suddenly feels like there’s duct tape on their forehead. “Botox will affect the way your facial muscles move, and it can feel funny when you can’t move your face to make a particular expression,” Dr. Shainhouse explains. “Also, sometimes injection of Botox in one area can affect another area—for example, injecting too low on the forehead to reduce wrinkles above the brows can actually end up lowering the brows, which is not always ideal. You may also experience a super-tight feeling in the beginning, before your body has time to adjust to the toxin.” These are the 50 things your surgeon won’t tell you.
Side effects from cosmetic use generally result from unintended paralysis of facial muscles. These include partial facial paralysis, muscle weakness, and trouble swallowing. Side effects are not limited to direct paralysis however, and can also include headaches, flu-like symptoms, and allergic reactions. Just as cosmetic treatments only last a number of months, paralysis side-effects can have the same durations. At least in some cases, these effects are reported to dissipate in the weeks after treatment. Bruising at the site of injection is not a side effect of the toxin but rather of the mode of administration, and is reported as preventable if the clinician applies pressure to the injection site; when it occurs, it is reported in specific cases to last 7–11 days. When injecting the masseter muscle of the jaw, loss of muscle function can result in a loss or reduction of power to chew solid foods.
As part of the settlement, Allergan agreed to plead guilty to one criminal misdemeanor misbranding charge and pay $375 million. The company acknowledged that its marketing of Botox led to off-label uses of the drug. Allergan also agreed to pay $225 million to resolve civil charges alleging that the marketing of Botox had caused doctors to file false reimbursement claims, though Allergan denied wrongdoing. The company said in a statement that the settlement was in the best interest of its stockholders because it avoided litigation costs and "permits us to focus our time and resources on ... developing new treatments."
Think about it this way: people make facial expressions every single day, whether it's expressing an emotion (i.e. smiling) or simply out of habit (i.e. raising your brows). Making facial expressions causes temporary dynamic lines to show up in your face. These lines go away when your face returns to rest. However, as you continue to make facial expressions, day after day and year after year, and as your skin ages, these lines start to get etched in your skin. That's when frown lines get progressively deeper for people who frown all the time. Or when crow's feet stay put even after you stop smiling or squinting. Eventually, what once were dynamic wrinkles become wrinkles that are just there, even when you don't make any facial expressions.
In many children, there are a few muscle groups that can have very active spasticity. A more focal approach to these muscles would be better than a widespread approach. In this case a doctor may advise a nerve block to interrupt the signal to the muscle that is spastic. Once the signal that is carried to the muscle by the nerve is interrupted, the spasticity will decrease.
Though botulinum toxin is available under different names, Botox is the only one that is FDA-approved for migraine prevention. To be considered for Botox, patients must have migraines 15 days or more per month, which is considered chronic daily migraine. About 4 million Americans have such migraines, according to the Migraine Research Foundation. Also, patients must have tried and failed on at least 2 other medications first.
The efficacy of BOTOX for the treatment of upper limb spasticity was evaluated in three randomized, multi-center, double-blind, placebo-controlled studies (Studies 1, 2, and 3). Two additional randomized, multi-center, double-blind, placebo-controlled studies for upper limb spasticity in adults also included the evaluation of the efficacy of BOTOX for the treatment of thumb spasticity (Studies 4 and 5).
In 1820, Justinus Kerner, a small-town German medical officer and romantic poet, gave the first complete description of clinical botulism based on extensive clinical observations of so-called “sausage poisoning”. Following experiments on animals and on himself, he concluded that the toxin acts by interrupting signal transmission in the somatic and autonomic motor systems, without affecting sensory signals or mental functions. He observed that the toxin develops under anaerobic conditions, and can be lethal in minute doses. His prescience in suggesting that the toxin might be used therapeutically earned him recognition as the pioneer of modern botulinum toxin therapy.
Botox can be bought by essentially any person with a DEA certificate. Allergan sells it in 50 and 100 unit vials. They are shipped overnight delivery on dry ice to keep the toxin effective it should be opened, reconstituted and used the same day ideally. The Botox will work best this way. Price points will change by who the injector is and what their motives are. Botox can be reconstituted so that you getting a very dilute amount of product. So a by the area approach may really only give you a small amount of product. Or you could be getting old Botox that is a week old and will not last for very long.
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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%).
In 1895 (seventy-five years later), Émile van Ermengem, professor of bacteriology and a student of Robert Koch, correctly described Clostridium botulinum as the bacterial source of the toxin. Thirty-four attendees at a funeral were poisoned by eating partially salted ham, an extract of which was found to cause botulism-like paralysis in laboratory animals. Van Ermengem isolated and grew the bacterium, and described its toxin, which was later purified by P Tessmer Snipe and Hermann Sommer.
Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles. It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.
The safety and efficacy of onabotulinumtoxinA for CM was demonstrated in the pivotal phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trial. In this trial, patients were treated every 12 weeks whether or not their headaches had returned to baseline levels and the primary outcome period was after two treatment cycles. At baseline, these patients had more than 19 headache days, and after two treatment cycles, their headaches had been reduced by 8 to 9 days per 28 days. The responder rate analysis of the study population shows that about 25% of patients improved by 75% in terms of a reduction of migraine days. In my practice, I usually do three cycles 12 weeks apart, and only if there is no change in headache frequency after this, do I change treatments. In the pivotal trials, the first statistical separation from placebo occurred in the first 4 weeks. There is a small subgroup of patients who fail to respond to the first two treatments and only start to respond after the third treatment.4-10
Study 2 compared 3 doses of BOTOX with placebo and included 91 patients [BOTOX 360 Units (N=21), BOTOX 180 Units (N=23), BOTOX 90 Units (N=21), and placebo (N=26)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone) who were at least 6 weeks post-stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimis, flexor carpi radialis, flexor carpi ulnaris, and bic eps brachii (see Table 27).
Botox is said to decrease the frequency of migraine days by an average of 50 percent for those who suffer chronically (people who experience 15 or more headache days per month). After going through hell with my insurance to get approval, I scheduled an appointment with New York City neurologist and pain-management specialist Risa Ravitz. She was kind enough to speak with me about the wonders of Botox while we did my first procedure in June 2017.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.