In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in wee kly frequency of incontinence episodes were observed for BOTOX (200 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction we re also observed. These primary and secondary endpoints are shown in Tables 21 and 22, and Figures 7 and 8.
"We were very skeptical," says Edwin Chapman, a professor of neuroscience at the University of Wisconsin--Madison, after reading Caleo's study. But in August 2016, Chapman and his graduate student Ewa Bomba-Warczak published a study in the journal Cell Reports showing similar spreading effects in animal cells in the lab. For Chapman, it explained what he was hearing anecdotally from doctors: that Botox might be influencing the central nervous system and not just the area where it's being injected.
In recent years, a number of high-profile lawsuits have been brought against Allergan in which plaintiffs claimed that off-label uses--for ailments including a child's cerebral-palsy symptoms, for instance, or an adult's hand tremors--resulted in lasting deleterious side effects. Still, the drug's acceptance in a growing number of doctors' offices worldwide, and its revenue growth, show no signs of slowing.
Not to be evasive, but the cost varies between physicians depending on how much Allergan product they purchase in a year. In general, it will probably be from $500 to $550 for a 100 unit vial. The equipment required to properly inject botox is not cheap, since it takes specialized syringes and needles that aid in precision and comfort. And properly trained staff and appropriately-medical... READ MORE
If you undergo Botox treatments for migraines, your doctor will typically administer them once every three months. Depending on your response to Botox, your doctor will recommend a length of time for your treatment plan. Each session will last between 10 and 15 minutes. During the sessions, your doctor will inject multiple doses of the medicine into specific points along the bridge of your nose, your temples, your forehead, the back of your head, your neck, and your upper back.
The studies using Botox for depression, like other research into Botox's off-label potential, were so encouraging that they caught the attention of Allergan. In Rosenthal and Finzi's research, 74 people with major depressive disorder were randomly assigned to receive Botox injections or a placebo. Six weeks later, 52% of the people who received Botox experienced a drop in reported symptoms, compared with 15% of the people given a placebo. "Over 50% of people responding is a high number," says Finzi. "These are people who have already tried other treatments, and they are significantly depressed."
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I increase the dose at each treatment cycle to 195 units. This is based on experience with patients with cervical dystonia, in whom higher doses result in a longer duration of effect. In addition, I transition to the next onabotulinumtoxinA treatment at 12 weeks by using occipital and trigeminal nerve blocks at 10 weeks. Most insurance companies will not cover onabotulinumtoxinA treatments earlier than 12 weeks, but in rare cases, 10-week cycles have been approved.
Reduced blinking from BOTOX injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other me ans.
Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
A follow-up visit is most often scheduled at around three months after injection. The team will determine if it was helpful and if the effect is wearing off. The effect on muscle spasticity by botulinum toxin is temporary and can last for up to three to five months. This also varies with the amount of toxin injected, the size of the muscle, the degree of spasticity in the muscle, and treatment such as therapy and bracing.
According to Ravitz, it's very effective among a large sampling of her patients and is usually very well tolerated. She says some of her patients find that it even eliminates the need for medication, which is a huge deal. However, she also says, "About 7 to 10 percent of my patients find that it’s not effective and they actually feel worse during that time." As with any medical procedure, everybody (and everyone's actual body) is different and will respond to treatment differently, and it's best to do a healthy amount of research and thoroughly talk to your doctor about your body and medical history before making a decision.
Besides the three primary U.S. manufacturers, there are numerous other botulinum toxin producers. Xeomin, manufactured in Germany by Merz, is also available for both therapeutic and cosmetic use in the U.S.[67] Lanzhou Institute of Biological Products in China manufactures a BTX-A product; as of 2014 it was the only BTX-A approved in China.[67] BTX-A is also sold as Lantox and Prosigne on the global market.[68] Neuronox, a BTX-A product, was introduced by Medy-Tox Inc. of South Korea in 2009;[69]
Contrary to popular belief, the bacteria that causes botulism, clostridium botulinum, is not part of the treatment, nor are six of the seven neurotoxins it secretes. The only substance used in Botox injections, botulinum toxin A, is carefully extracted, purified, and standardized into FDA-approved doses. Plus, the dosage is so small, it can't get beyond the muscle tissue it's injected into, meaning there's little if any chance for Botox to reach the bloodstream.
Treatment with BOTOX and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a conseq uence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing [see Spread Of Toxin Effect].
Ophthalmologists specializing in eye muscle disorders (strabismus) had developed the method of EMG-guided injection (using the electromyogram, the electrical signal from an activated muscle, to guide injection) of local anesthetics as a diagnostic technique for evaluating an individual muscle’s contribution to an eye movement.[44] Because strabismus surgery frequently needed repeating, a search was undertaken for non-surgical, injection treatments using various anesthetics, alcohols, enzymes, enzyme blockers, and snake neurotoxins. Finally, inspired by Daniel Drachman’s work with chicks at Johns Hopkins,[45] Alan B Scott and colleagues injected botulinum toxin into monkey extraocular muscles.[46] The result was remarkable: a few picograms induced paralysis that was confined to the target muscle, long in duration, and without side-effects.
Some industry insiders say it's not unusual, if still legally murky, for drug-company representatives and doctors to share information with one another about the different ways an approved drug may be used. If a doctor notices that, say, a treatment for crossed eyes also "takes the lines out," he may mention it to the representative from whom he buys the drugs. That rep may share that with another of his clients, and so on.
BOTOX® Cosmetic targets one of the underlying causes of frown lines, crow’s feet and forehead lines — the repeated muscle contractions from frowning, squinting, smiling and raising the eyebrows over the years. Your specialist will inject these muscles with BOTOX® Cosmetic to temporarily reduce muscle activity. You will begin to notice a visible smoothing of the frown lines between your brows, your crow’s feet lines and your forehead lines.
When asked how often he turns people away, Dr. Matarasso says: “I turned someone away today. I had a gentleman come in, he was an appropriate candidate anatomically, he had some deep lines in his forehead, but his expectations were unrealistic. He wanted every line erased, and I said, ‘No, you are going to look a little mask-like.’ I gave him a brochure and said, 'Go home and think about it.'”
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Food-borne botulism results, indirectly, from ingestion of food contaminated with Clostridium spores, where exposure to an anaerobic environment allows the spores to germinate, after which the bacteria can multiply and produce toxin.[citation needed] Critically, it is ingestion of toxin rather than spores or vegetative bacteria that causes botulism.[citation needed] Botulism is nevertheless known to be transmitted through canned foods not cooked correctly before canning or after can opening, and so is preventable.[citation needed] Infant botulism cases arise chiefly as a result of environmental exposure and are therefore more difficult to prevent.[citation needed] Infant botulism arising from consumption of honey can be prevented by eliminating honey from diets of children less than 12 months old.[71]
BOTOX, highly diluted botulinium toxin, works to prevent migraine by blocking the release of a chemical in muscle cells that transmits the signal to contract to muscle fibers. Research into using BOTOX to treat migraines began after patients receiving it for other conditions reported improvement in their migraine symptoms. In 2010, after years of research and collecting clinical data, the FDA approved BOTOX for treating chronic migraines.
In order to minimize the chance of developing a bruise, the key thing to prep for your injections should be to stop all blood thinners (like aspirin, Advil, Motrin, fish oil ,omega 3  vitamin E and other product) prior to making an appointment for an injection. Staying off blood thinners for at least one week is ideal but chilling the skin prior to treatment will reduce the chances of a bruise.
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.
Dr. Engelman says preventative is legit. “Most certainly! I do micro-injections on patients who are just starting to show the finest expression lines in order to prevent them from ever making the wrinkle." NYC-based board-certified plastic surgeon Norman Rowe, MD, is also a fan. "While Botox has a fundamental use in treating wrinkles that are already formed, it has a role in the prophylactic, or prevention, of wrinkles. So, don't think that you don't need Botox because you don't have wrinkles. If you want to keep that smooth skin, start with Botox before they form."
That Groupon offer might be tempting, but Dr. Tutela recommends doing a thorough vetting of your practitioner’s history and methods before signing up for treatment. “I think it is important to ask any provider if they perform that procedure frequently, to gauge their experience,” he says. He also suggests to ask if they’ve experienced any major complications and to check their online reviews. “You can get a sense of how you will be treated and what kind of experience other patients have had,” Dr. Tutela says. “Many of those low-cost, high-volume practices are loaded with horrible reviews from disappointed patients.”
During treatment, very low doses of Botox® Cosmetic are administered via a few tiny injections directly into the muscles responsible for frown lines between the brows. By blocking the release of a chemical that causes them to contract, Botox® Cosmetic enables them to relax. The effects are very localized and, when administered by an experienced injector, do not affect your ability to smile, laugh, or otherwise show expression. Botox® Cosmetic is the only product of its kind that has been approved for use in this area.
Sarah of My Migraine Life is a mom living with chronic migraine and daily headaches who has tried a gamete of medications, alternative therapies and lifestyle changes. These experiences led her to write “My Migraine Life,” a website for people living with migraine and their caretakers devoted to telling stories, raising awareness, giving support, product reviews and more. My Migraine Life is a partner of the American Migraine Foundation.
Lalvani previously worked in organizations dedicated to diabetes, breast cancer and kidney disease, but strongly identifies with our community because she is living with migraine. She recalls first getting what she thought were terribly debilitating headaches when she was 18. “I had no idea what a migraine was,” she said, “and I never saw anyone around me have a migraine, so I had no idea what I was dealing with, and no one else around me knew what I was dealing with.” Lalvani is excited to see the progress that’s been made recently in migraine care and the tremendous effort that AMF has put forth in helping advance research to produce therapies at a faster rate. As you know, the mission for AMF is to drive and support impactful research that translates into treatment advances as well as mobilize the community for patient support and advocacy.
Prior to injection, reconstitute each vacuum-dried vial of BOTOX with only sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detr usor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX should be stored in a refrigerator (2° to 8°C).
Both Aetna and HealthPartners tell The Verge in an email that they don’t require patients to try verapamil specifically. “Verapamil is just one of many options available to treat migraines. Some are FDA-approved, others are not,” says Becca Johnson, a spokesperson for HealthPartners. Patients are required to try other oral medications because they’re either cheaper or not as invasive as getting Botox injections. “The rationale is that these medications are generally effective and safe,” says Ethan Slavin, a spokesperson for Aetna.
"In the majority of these cases, it's the doctors at the front line who start using Botox off-label, and then we see the treatment of things we never expected the toxin to work for," says Min Dong, a researcher at Harvard Medical School who studies botulinum toxins in the lab and has no financial ties to Allergan. "I meet with physicians who are using the toxin everywhere--for diseases you would never know about."
Dr. Engelman says preventative is legit. “Most certainly! I do micro-injections on patients who are just starting to show the finest expression lines in order to prevent them from ever making the wrinkle." NYC-based board-certified plastic surgeon Norman Rowe, MD, is also a fan. "While Botox has a fundamental use in treating wrinkles that are already formed, it has a role in the prophylactic, or prevention, of wrinkles. So, don't think that you don't need Botox because you don't have wrinkles. If you want to keep that smooth skin, start with Botox before they form."
Study 4 included 170 patients (87 BOTOX and 83 placebo) with upper limb spasticity who were at least 6 months post-stroke. In Study 4, patients received 20 Units of BOTOX into the adductor pollicis and flexor pollicis longus (total BOTOX dose =40 Units in thumb muscles) or placebo (see Table 30). Study 5 included 109 patients with upper limb spasticity who were at least 6 months post-stroke. In Study 5, patients received 15 Units (low dose) or 20 Units (high dose) of BOTOX into the adductor pollicis and flexor pollicis longus under EMG guidance (total BOTOX low dose =30 Units, total BOTOX high dose =40 Units), or placebo (see Table 30). The duration of follow-up in Study 4 and Study 5 was 12 weeks.
Most people tolerate the injection discomfort well. But you may want your skin to be numbed beforehand, especially if your palms or soles are being treated for excessive sweating. Your doctor might use one or more of various methods available to numb the area, such as topical anesthesia, ice and vibration anesthesia, which uses massage to reduce discomfort.
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Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
The FDA approval was based on a large study showing that Botox significantly reduced migraine frequency and severity, as well as headache-related disability, compared to placebo. As just one measure of its effectiveness, many of my patients report that they’ve cut their use of rescue medications in half since starting Botox – a significant benefit for people who previously had to resort to rescue medications 15 or more times every month.
Botulism is an illness caused by a neurotoxin produced by the bacterium Clostridium botulinum. There are three types of botulism: food-borne, wound, and infant. Symptoms include muscle paralysis, dry mouth, constipation, slurred speech, and blurred vision. If food-borne and wound botulism are detected early enough, they may be treated with an antitoxin. Infant botulism is treated intravenously with BabyBIG (Botulism Immune Globulin).

Launched in 2002, Practical Neurology is a publication uniquely dedicated to presenting current approaches to patient management, synthesis of emerging research and data, and analysis of industry news with a goal to facilitate practical application and improved clinical practice for all neurologists. Our straightforward articles give neurologists tools they can immediately put into practice.
Galli has been living with migraine for most of her adult life, but recently, her attacks became more severe and frequent. “My whole life went upside down and nothing was the same,” Galli says, upon being diagnosed with chronic migraine. “The person I used to be wasn't there anymore. I didn't even recognize myself.” To cope with the symptoms that often accompany chronic migraine, Galli found herself retreating to a dark room, waiting for the pain to pass, but it never did. In response, Galli says, she asked herself what she could do to feel better but also share her story. “Everyone around me that knew how high energy, and how much of a go-getter I am, asked what was happening? Where was that person?” When she came across the announcement of the Migraine Moment Film Contest, she saw it as her opportunity to bring awareness about what it is like to live with migraine and bust the misconceptions surrounding this invisible disease. Enter: “Invisible Hero.”
* LS mean change, treatment difference and p-value are based on an analysis using an ANCOVA model with baseline weekly endpoint as covariate and treatment group, etiology at study entry (spinal cord injury or multiple sclerosis), concurrent anticholinergic therapy at screening, and investigator as factors. LOCF values were used to analyze the primary efficacy variable.

Botox, or onabotulinumtoxinA, is used for three main purposes: muscle spasm control, severe underarm sweating and cosmetic improvement. In this article we concentrate on the third use, achieved with the product called Botox Cosmetic, which contains botulinum toxin type A (the active ingredient), human albumin (a protein found in human blood plasma) and sodium chloride.
Yes. The number of men receiving cosmetic treatments overall has risen by 325% over the last 20 years. And the number of men specifically choosing treatments like BOTOX® Cosmetic has also risen fast– in the past three years alone, men have received over one million botulinum toxin treatments. When surveyed, the majority of men say they want to look good and they’re bothered by the changes they see in the mirror. 80% would choose to treat their crow’s feet first, while 74% would prioritize their forehead lines, and 60% would most like to treat their frown lines.†
Botox, or onabotulinumtoxinA, is used for three main purposes: muscle spasm control, severe underarm sweating and cosmetic improvement. In this article we concentrate on the third use, achieved with the product called Botox Cosmetic, which contains botulinum toxin type A (the active ingredient), human albumin (a protein found in human blood plasma) and sodium chloride.

On July 29, 2016, Food and Drug Administration (FDA), of the United States of America approved abobotulinumtoxinA for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older.[20] AbobotulinumtoxinA is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. In the United States of America, the FDA approves the text of the labels of prescription medicines. The FDA approves which medical conditions the drug manufacturer may sell the drug for. However, those approved by the FDA to prescribe these drugs may freely prescribe them for any condition they wish, called off-label use. Botulinum toxins have been used off-label for several pediatric conditions, including infantile esotropia.[21]
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