Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions a ssociated with the unapproved uses of BOTOX. The safety and effectiveness of BOTOX for unapproved uses have not been established.

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.'”


In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of urinary incontinence episodes were observed for BOTOX 100 Units at the primary time point of week 1 2. Significant improvements compared to placebo were also observed for the secondary efficacy variables of daily frequency of micturition episodes and volume voided per micturition. These primary and secondary variables are shown in Tables 19 and 20, and Figures 5 and 6.
After a muscle has been injected, the nerves still send the signal to the muscle to contract, and the acetylcholine is still released, but is unable to bind to the muscle, resulting in a reduction of muscle activity and temporarily preventing contraction of the muscles that cause frown lines. The binding process typically begins within about 48 hours from the time it is injected into the muscle, and results typically become noticeable within 7 to 10 days. While results are often most noticeable in dynamic wrinkles (wrinkles that appear when a muscle contracts), it can also help soften wrinkles that are present even without muscle contraction. If you’re serious about improving the appearance of moderate to severe frown lines, it may be just the right treatment option for you.
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
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.
The most commonly reported side effects for JUVÉDERM® injectable gels were injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, side effects were predominantly moderate in severity, with duration of 2 to 4 weeks; for JUVÉDERM® Ultra XC , JUVÉDERM® Ultra Plus XC, or JUVÉDERM VOLLURE™ XC, they were mostly mild or moderate in severity, with duration of 14 days or less; and for JUVÉDERM VOLBELLA® XC, they were predominantly mild or moderate, with duration of 30 days or less.

When I wean patients off of treatment, I do not change the dose but rather delay the treatment cycle to 16 weeks and monitor headaches in the last 4 weeks. If the patient remains well-controlled, I increase the treatment window to 20 weeks, and so on. I use this method to establish the level at which patients need reinjection to prevent breakthrough headaches.11-13
A BOTOX “treatment” consists of 31 injections to the head and neck areas, if adherence to the FDA approved protocol is followed. Except for injection into the procerus, which is in the midline, all others are paired sets of injections on the left and right sides. Muscles included are the frontalis and temporalis areas as well as the occipitalis, upper cervical paraspinals, and trapezii. The amount injected at each of the 31 injection sites is small—5 units of BOTOX in a volume of 0.1 mL normal saline or sterile water. A total of 155 units is are typically used.
As with the injection of any medication, your body's immune system can develop antibodies to the medication, which render the drug less effective or possibly cause development of an allergy to the drug. The more frequently the drug is injected or the more quantity that is injected, the higher the risk for these antibodies to be formed against the drug.

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BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
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
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 1 included 126 patients (64 BOTOX and 62 placebo) with upper limb spasticity (Ashworth score of at least 3 for wrist flexor tone and at least 2 for finger flexor tone) who were at least 6 months post -stroke. BOTOX (a total dose of 200 Units to 240 Units) and placebo were injected intramuscularly (IM) into the flexor digitorum profundus, flexor digito rum sublimis, flexor carpi radialis, flexor carpi ulnaris, and if necessary into the adductor pollicis and flexor pollicis longus (see Table 25). Use of an EMG/nerve stimulator was recommended to assist in proper muscle localization for injection. Patients were followed for 12 weeks.

It's safe to say that the mouth is the clearest giveaway of work done too early. Youthful lips tend to have substantial volume and turn up naturally at the corners, meaning the best strategy for flattering them often comes down to a good signature lip color. For women who remain self conscious about the size or symmetry of their lips—think a slightly lopsided appearance, for instance—Botox can be injected into the orbicularis oris muscle along the lip line as an alternative to lip fillers. "When certain individuals smile, the lip flips in and they lose that upper volume," says Dara Liotta, a New York City-based plastic and cosmetic surgeon. "This relaxes the outer layers of the circular muscle around the lips and looks much more natural than filler." Additionally, injections along the jawline—or more specifically, the masseter muscle—have risen in popularity to relieve stress-induced jaw clenching and have also been known to refine the area. "A lot of people hold tension in the jaw area and when you relax that muscle, the chin comes out of the shadow of your lower lip,” explains Liotta. But the best advice of all? Forget about those self-perceived imperfections and smile. You're only in your '20s once.
Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur

In detrusor overactivity associated with neurologic condition patients with analyzed specimens in the drug development program (including the open-label extension study), neutralizing antibodies developed in 3 of 300 patients (1.0%) after receiving only BOTOX 200 Unit doses and 5 of 258 patients (1.9%) after receiving at least one 300 Unit dose. Following development of neutralizing antibodies in these 8 patients, 4 continued to experience clinical benefit, 2 did not experience clinical benefit, and the effect on the response to BOTOX in the remaining 2 patients is not known.
On average, each BOTOX treatment requires 32 injections, though individual patients may require fewer or more. You’ll receive injections every twelve weeks, and each session only takes a few minutes. BOTOX begins to work as soon as it’s injected, and you should see full results within a week of your first injections. Most patients who benefit from BOTOX treatments receive five rounds of injections over 15 months. BOTOX is injected using a very fine needle. Most patients describe it as feeling like a tiny pinprick.
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.”
The other method of calculating the cost of Botox is to pay by the area being treated. Doctors will specify the total cost for a designated region of the face -- for example, in the United States it should cost between $250 and $500 to treat horizontal forehead lines. However, it’s important to note that the forehead is treated as two seperate areas--the forehead lines that run horizontally across the forehead, and the frown lines that appear at the glabella. If you were to pay per area treated you would need to pay for two different areas. This method of pricing can sometimes mean you pay for more than what you need, especially if you don’t have deeply-etched wrinkles. At the same time, there’s an advantage to knowing how much the treatment will cost before you undergo the procedure, leaving no room for any unwelcome surprises.
    Some skin care centers advertise low prices for Botox on a "cost per area" basis, advertising prices of $200-$300 for one area. The doctor we spoke to recommends getting price quotes on a "cost per unit" basis, because some places might be quoting lower prices but giving you smaller treatments, which may be less effective and require more frequent visits.

In 1986, Scott's micromanufacturer and distributor of Botox was no longer able to supply the drug because of an inability to obtain product liability insurance. Patients became desperate, as supplies of Botox were gradually consumed, forcing him to abandon patients who would have been due for their next injection. For a period of four months, American blepharospasm patients had to arrange to have their injections performed by participating doctors at Canadian eye centers until the liability issues could be resolved.[48]
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
This is where Botox comes into play. When you get consistent Botox injections, you prevent potential wrinkle formations from getting deeper or worse. Botox limits the range of facial muscle movement (when done skillfully, your face will not get that frozen look) so that wrinkles don't worsen over time. If you have a bad habit of frowning or lifting your brows for no reason, consistent Botox injections can also help your face kick these bad habits and therefore prevent any potential lines from getting etched in your skin. Getting frequent Botox injections may also help relax your facial muscles so that you don't need as a high a dose or as frequent as an injection to maintain your results.
Even if Botox's mechanism isn't always well understood and some of its off-label uses are still unproven, interest in the drug isn't likely to wane. "Botox is a big cash cow for the physicians' practices," says Ronny Gal, an investment analyst at Sanford C. Bernstein who has watched the drug closely for more than a decade. "When I talk to physicians, they say, 'Botox is not a problem. It works and gives you the result you want.' If it works for depression and atrial fibrillation, it could be massive."
It takes a village to raise a child. My family members are well aware of how I cope with migraine. They make themselves available to help my children and me often. I rely on people to drive me to doctor’s appointments as well as take my children to sports practices. I arrange carpools and am honest with the people in our lives about how a migraine attack can be unpredictable and suddenly change plans. Every year, I alert my children’s teachers of my chronic migraine and ask them to watch and listen for signs of migraine or stress in my children. I worry about them physically and emotionally and so far, they have handled my disease as they would any other illness. By being honest about the help I need, I find that the people in my life are better equipped to follow through. Many people would like to help but don’t know how. I have given up pride and allowed others to help, which inevitably takes stress away from us all.
In 1998, David E.I. Pyott became CEO of Allergan. He was enthusiastic about Botox's wrinkle-reducing potential, he says, and pushed the company to conduct a series of studies on the matter. In 2002, Botox earned FDA approval for so-called frown lines--wrinkles between eyebrows--marking the first time a pharmaceutical drug was given the green light for a strictly cosmetic purpose. In 2001, the year before Botox was approved for wrinkles, it generated about $310 million in sales. By 2013, the year it was approved for overactive bladder, Allergan reported nearly $2 billion in revenue from Botox.
If, however, you are on a budget, you might want to wait until the end of the year to get your Botox injections. Botox promotions, whether from the Brilliant Distinctions program or from individual doctor's offices, are more common towards the end of the year when people want to get touch ups and look their best for the holidays. However, if someone is offering Botox for a ridiculously cheap price (like you sometimes see on deal websites like Groupon.com), that should raise some red flags. You tend to get what you pay for and in my experience with my mom's Botox treatments, it is better to overpay than underpay. Don't get Botox from a shady place just because it's cheap. Remember, you are not only paying for the units of Botox per treatment, you are also paying for the skill and expertise of the doctor. So make sure you get Botox from a well-trained, reputable physician!
Note: Online coupons or deals for Botox are not recommended because you would be purchasing a medical treatment without knowing if the treatment would be suitable for your skin issues. What you think Botox will fix may not actually be the case, so don't buy something unless you know you are a good candidate for the treatment. It's better to get a Botox consultation first.
"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."
Wrinkles, whether they be fine line or deep furrows, typically appear on areas of the body that receive a high amount of exposure to the sun. Smoking, light skin type, hairstyle, the way you dress, your occupational and recreational habits, and heredity are all factors that promote wrinkling. Medical treatments for wrinkles include antioxidants, moisturizers, alpha-hydroxy acids, and vitamin A acid. Cosmetic procedures that treat wrinkles include dermabrasion, microdermabrasion, glycolic acid peels, laser resurfacing, Botox, and fillers.

If you are seeking a Botox specialist, I have more than thirty years experience injecting Botox in New York City and New Jersey. I am a recognized oculoplastic surgeon – you can find me on Google as Dr. Joel E. Kopelman. I have authored several peer reviewed articles regarding the efficacy and safety of Botox injections. You can easily make an appointment to see me in consultation at our office +1 (212) 831-8333 to set up a consultation with me in either New York or New Jersey.
Postmarketing reports indicate that the effects of BOTOX® Cosmetic 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's also not approved by the U.S. Food and Drug Administration (FDA) for depression, not that that stops doctors from prescribing it that way. Such off-label use of Botox, like that of any FDA-approved drug, is legal in the U.S. That's because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit, regardless of whether it's been proved to work for that condition.


Richard Clark, a plastic surgeon from Sacramento (CA), was the first to document a cosmetic use for botulinum toxin.[51] He treated forehead asymmetry caused by left sided forehead nerve paralysis that occurred during a cosmetic facelift. Since the injured nerve could possibly regenerate by 24 months, a two-year waiting period was necessary before definitive surgical treatment could be done. Clark realized that botulinum toxin, which had been previously used only for cross eyed babies and facial tics, could also be injected to smooth the wrinkles of the right forehead to match her paralyzed left. He received FDA approval for this cosmetic application of the toxin and successfully treated the person and published the case study in 1989.[51]


In fertility studies of BOTOX (4, 8, or 16 Units/kg) in which either male or female rats were injected intramuscularly prior to mating and on the day of mating (3 doses, 2 weeks apart for males, 2 doses, 2 weeks apart for females) to untreated animals, reduced fertility was observed in males at the intermediate and high doses and in females at the high dose. The no -effect doses for reproductive toxicity (4 Units/kg in males, 8 Units/kg in females) are approximately equal to the maximum recommended human dose of 400 Units on a body weight basis (Units/kg).
The co-primary endpoints were the average of the change from baseline in modified Ashworth Scale (MAS) ankle score at Week 4 and Week 6, and the average of the Physician Global Assessment of Response (CGI) at Week 4 and Week 6. The CGI evaluated the response to treatment in terms of how the patient was doing in his/her life using a 9-point scale from -4=very marked worsening to +4=very marked improvement).
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.
The most common severe adverse reaction associated with the use of BOTOX injection in patients with cervical dystonia is dysp hagia with about 20% of these cases also reporting dyspnea [see WARNINGS AND PRECAUTIONS]. Most dysphagia is reported as mild or moderate in severity. However, it may be associated with more severe signs and symptoms [see WARNINGS AND PRECAUTIONS].
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]

How long the results from a Botox treatment last depends on the dosage and application. If Botox is too diluted and you don't get the proper units of Botox injected, the results might not last very long at all. If you get Botox for the wrong kind of wrinkles (i.e. static wrinkles) or an improper dose for your anatomy, you might not see much improvement either. In general, if the right amount of Botox is injected by a skilled doctor in the right muscles, Botox results can last 3-4 months.
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
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Costs to consider: immediate out-of-pocket costs, long-term higher cost of insurance, your time, and the pain of injections. Botox for migraine costs approximately $525 per vial (100 units) and a typical migraine dose is 155 units. Depending on what your doctor charges in addition to the Botox itself, it’ll set you back $1500 – $2300 to test it out. And then there’s the needle pain. Don’t make the mistake of going to get a Botox injection if you’re in the midst of an attack, because it’ll be more painful than ever. Better to reschedule.
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.
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