Postmarketing reports indicate that the effects of BOTOX® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat Cervical Dystonia and spasticity and at lower doses.
It was peculiar advice coming from a shrink, but not without precedent. In 2014, Rosenthal, a clinical professor of psychiatry at Georgetown University School of Medicine, and Dr. Eric Finzi, an assistant professor of psychiatry at George Washington School of Medicine, published a study showing that when people with major depression got Botox, they reported fewer symptoms six weeks later than people who had been given placebo injections. "I'm always on the lookout for things that are unusual and interesting for depression," says Rosenthal, who is widely considered an expert on the condition. "I've found Botox to be helpful, but it's still not mainstream."
Headache is a universal experience. At present, there are more than 100 different types of headache and one of the most recurring ones is migraine, which affects approximately 10-12% of the population, being three times more common in women than in men. When migraine becomes chronic -occurring more than 15 days a month-, it can disrupt patients' daily life in a great degree.
Headache is a universal experience. At present, there are more than 100 different types of headache and one of the most recurring ones is migraine, which affects approximately 10-12% of the population, being three times more common in women than in men. When migraine becomes chronic -occurring more than 15 days a month-, it can disrupt patients' daily life in a great degree.
Finding an experienced practitioner is particularly important if you’ve never had Botox treatments before as he or she will devise an optimal treatment plan to address your forehead wrinkles. Furthermore, with an experienced, board-certified plastic surgeon you’ll be far less likely to experience any side effects like pain, bruising around the injection site, droopy eyelids, or mistakenly be administered too much Botox, leaving your face looking frozen for the next several months.
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.
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”.[37] 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.[38] His prescience in suggesting that the toxin might be used therapeutically earned him recognition as the pioneer of modern botulinum toxin therapy.[39]
Overall, with the exception of Overactive Bladder (see below), clinical studies of BOTOX did not include sufficient numbers o f subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. There were too few patients over the age of 75 to enable any comparisons. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease o r other drug therapy.
BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.

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).
Other things to know about Botox treatments: Some providers charge a consultation fee, which is waived if you choose to proceed with the injections but charged if you decline. Also, who is doing the injection? Make sure it’s a trained, certified professional. As in many other things, training and credentials are important. In some practices, a junior employee may perform the procedure for a lesser rate. Make sure that’s what you want.

“Botox is a completely cosmetic procedure, so if and when someone ‘needs’ it is a purely personal decision,” Shah says. “Some people are not bothered by developing fine lines and wrinkles. For those who are, I generally advise starting treatments just when they start to see the lines develop, or when the wrinkles linger even after the movement has stopped.”
The recommended dose is 50 Units per axilla. The hyperhidrotic area to be injected should be defined using standard staining techniques, e.g., Minor's Iodine-Starch Test. The recommended dilution is 100 Units/4 mL with 0.9% preservative -free sterile saline (see Table 1). Using a sterile 30 gauge needle, 50 Units of BOTOX (2 mL) is injected intradermally in 0.1 to 0.2 mL aliquots to each axilla evenly distributed in multiple sites (10-15) approximately 1-2 cm apart.

Remember that the skill of the injector is extremely important when considering Botox injections. Because Botox can have some very obvious and embarrassing side effects like drooping eyelids, blurry vision, and excessive bruising around the injection site, it's important to consult with an experienced injector. Unlike dermal fillers which can be melted away with a follow-up injection of hyaluronidase, there's not much you can do about a bad Botox experience other than wait it out.


So what exactly are you putting into your face? John Paul Tutela, MD, a board certified plastic surgeon, explains, “Botox is a cosmetic injectable neurotoxin that is a very diluted form of Botulinum Toxin, which is found in the bacteria Clostridium botulinum. In this diluted format, it is used to relax your muscles—typically in your forehead, in between your eyebrows, and around your eyes.” The idea is that if you temporarily block local nerve impulses to specific muscles within your face, you won’t make certain facial expressions, so you won’t form the wrinkles that come with them, explains dermatologist Tsippora Shainhouse, MD, FAAD. These are the 7 signs you’re ready for Botox? (And 6 signs you aren’t.)
Aesthetician Mary Schook is anti-Botox because she sees the long-term effects on her clients. “Everyone is always like, ‘Look how great this looks,’ and then there is the long-term and they are like, 'Fix me,'” she says. “Allergan [the company that owns Botox] says one in 100 patients gets eyelid-drop, so I always joke, ‘I must meet one in 100 patients, because everyone I see has that drop.'”
Selecting the correct injection points is critical to the success of the procedure. These points are first scored with a marking pencil. Your doctor will likely select numerous injection points for each location to be treated. (These points are located where the muscle contracts — not necessarily at the wrinkle you are hoping to erase.) The Botox filler is then injected into the marked points beneath the skin.
The median duration of response in study NDO-3, based on patient qualification for re-treatment was 362 days (52 weeks) for the BOTOX 100 Units dose group compared to 88 days (13 weeks) for placebo. To qualify for re-treatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least 2 urinary incontinence episodes over 3 days with no more than 1 incontinence -free day.
Study 3 compared 3 doses of BOTOX with placebo and enrolled 88 patients [BOTOX 360 Units (N=23), BOTOX 180 Units (N=23), BOTOX 90 Units (N=23), and placebo (N=19)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone and/or finger 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 sublimi s, flexor carpi radialis, flexor carpi ulnaris, and biceps brachii (see Table 27).
Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.
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.
García Leiva specified that this treatment "is not a first-choice treatment for migraine sufferers, but it can only be applied in patients with chronic migraine who have tried several treatments with poor results, and who show peripheral sensitization of muscles. Recently, the Foods and Drugs Administration (USA) has approved botulinum toxin as a therapeutical drug for the treatment of chronic migraine.
The only difference between the two procedures is that with Botox for migraines, they may do a few more shots in areas where the pain is experienced. Personally, I usually get between 30 and 40 shots, concentrated mostly on the right side of my head where the pain occurs, at the base of my skull, and on my neck and shoulders, where I tend to hold tension, as doing so can cause a migraine. Botox for migraines can have the same aesthetic effect that cosmetic Botox has, which kills two birds with one stone for people who may desire that effect. "We do it along wrinkle lines and keep it symmetrical," says Ravitz, which explains the erasing of lines and temporary plumping of wrinkles.
Botox should only be injected with sterile instruments in a doctor's office or a medical spa — not at Botox parties at your local nail salon or neighbor's living room. Botox injection is usually performed with some local anesthesia or a numbing cream. You may feel some minimal discomfort from the shot, but today's needles are so thin and fine that the procedure is often painless. Depending on the extent of treatment, the procedure can take anywhere from a few minutes to 20 minutes.
In general, adverse reactions occur within the first week follo wing injection of BOTOX and while generally transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.
Extraocular muscles adjacent to the injection site can be affected, causing vertical deviation, especially with higher do ses of BOTOX. The incidence rates of these adverse effects in 2058 adults who received a total of 3650 injections for horizontal strabismus was 17%. The incidence of ptosis has been reported to be dependent on the location of the injected muscles, 1% after inferior rectus injections, 16% after horizontal rectus injections and 38% after superior rectus injections.
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.†
A randomized, multi-center, double-blind, placebo-controlled study of the treatment of cervical dystonia was conducted. This study enrolled adult patients with cervical dystonia and a history of having received BOTOX in an open label manner with perceived good response and tolerable side effects. Patients were excluded if they had previously received surgical or other denervation tre atment for their symptoms or had a known history of neuromuscular disorder. Subjects participated in an open label enrichment period where they received their previously employed dose of BOTOX. Only patients who were again perceived as showing a response were advanced to the randomized evaluation period. The muscles in which the blinded study agent injections we re to be administered were determined on an individual patient basis.
Migraine with visual aura involves visual effects that usually precede the headache and last at least 5 minutes. The visual aura is usually an expanding blinding spot or visual scintillations (shimmering objects in the visual field). Other aura features include reversible symptoms of speech and language difficulty such as word-finding problems and aphasia (inability to express words or comprehend words), sensory phenomena such as tingling in the extremities extending to the face, motor effects such as weakness, and brainstem problems such as unsteadiness and features of cranial nerve dysfunction. These aura symptoms usually last 5 to 60 minutes, can precede or start during the headache, and can also occur without a headache.
If going back for additional treatments three or four times a year sounds like a lot of treatments, the good news is that the more Botox treatments you get, the fewer Botox units you'll need. With each repeat Botox session, the frontalis muscle and other facial muscles surrounding Botox injection sites get a little weaker and become "trained" to not contract.
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.
Please note, there are no guaranteed results with BOTOX and results may vary from patients to patient. Though BOTOX is not effective for all types of headaches, about 90% of MRC’s patients report that their migraines are less frequent and not as severe after BOTOX treatment. In clinical trials, patients reported seven to nine fewer headaches per month. In a study by A. H. Elkind, P. O’Carroll, A. Blumenfeld, R. DeGryse, and R. Dimitrova, a standard course of treatment brought patients these results:

In just over a decade, the number of people in the U.S. receiving cosmetic botulinum toxin type A injections--mostly from Botox but also from another brand called Dysport, which commands less than 10% of the market--exploded. From 2000 to 2015, use of the toxins for wrinkles increased 759%. It became a cultural phenomenon too, spawning Botox parties, Simpsons jokes, even greeting cards. In 2008, Sex and the City character Samantha famously quipped, "I don't really believe in marriage. Now Botox, on the other hand, that works every time."


A recent encounter with one of my headache patients got me thinking. I am treating this young woman for chronic migraine with BOTOX injections. She told me that one of her other physicians had been surprised to hear about this use for onabotulinumtoxin A. According to my patient, the gastroenterologist’s words were, “BOTOX for migraines? I’ve never heard of that.” 
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
A recent encounter with one of my headache patients got me thinking. I am treating this young woman for chronic migraine with BOTOX injections. She told me that one of her other physicians had been surprised to hear about this use for onabotulinumtoxin A. According to my patient, the gastroenterologist’s words were, “BOTOX for migraines? I’ve never heard of that.” 
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.[citation needed] The toxin itself is rapidly destroyed by heat, such as in thorough cooking.[72] The spores that produce the toxin are heat-tolerant and will survive boiling water for an extended period of time.[73]
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported.
A concern of both parents and children is whether these injections will be painful. There is no pain linked to the action of the toxin itself, only with the needle injections. To lessen this problem, the skin where the injections will be done is coated with EMLA cream before the procedure . A topical coolant spray is also used right before the needle is put in. This numbs the skin. The child may still feel pressure from the needle and a dull feeling in the muscle. The fact that a child is having a procedure done and is being held in place can upset a child more than the needle going in, even more so for preschool-aged children.
Much like other fillers, Botox is slowly metabolized in the system, so for it to remain effective, patients have to get the procedure every three months or so (however, as Ravitz told me during a recent visit, you can't get it done too frequently or your body will develop antibodies). I've now had four additional rounds of Botox since my initial procedure and have learned a lot about how my body reacts to it. Read on for both Ravitz's insight and information about my experience with five rounds of Botox.
If you think either of the FDA-approved anti-CGRP treatments might be right for you, speak with your primary health care provider, neurologist or headache specialist. If your medical provider isn’t aware of the treatments, don’t be afraid to let him or her know about them, or ask for a referral to a local neurologist or headache specialist. This is just the first step in advocating for the care that you deserve. To find a headache specialist in your area, consult our Find a Doctor tool. Dr. Starling believes that every person with migraine should be involved in advocacy, in order to bring awareness to the disease and break the stigma that surrounds it. She recommends that patients living with migraine get involved in advocacy organizations, such as our Move Against Migraine support community. You can also attend the annual Headache on the Hill event in which patients and providers go to Capitol Hill asking for more National Institutes of Health (NIH) research funding for migraine and other headache disorders. The next Headache on the Hill event is planned for February 11-12, 2019. Within the coming weeks, the American Migraine Foundation will be compiling a guide to all three anti-CGRP treatments. For additional information on anti-CGRP migraine treatment options, consult our doctor-verified resource library.

Botox is considered as an elective procedure which means that the insurance does not cover the cost. But in case of treating medical conditions, an insurance can cover the cost of the treatment but make sure to consult your doctor regarding the coverage. Botox injections can also be used to treat conditions such as excessive perspiration (hyperhidrosis), migraine and muscle spasticity.
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 clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
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