Exploratory analyses of this study suggested that the majority of patients who had shown a beneficial response by week 6 had returned to their baseline status by 3 months after treatment. Exploratory analyses of subsets by patient sex and age suggest that both sexes receive benefit, although female patients may receive somewhat greater amounts than male patients. There is a consistent trea tmentassociated effect between subsets greater than and less than age 65. There were too few non-Caucasian patients enrolled to draw any conclusions regarding relative efficacy in racial subsets.
Still, Botox's use for depression raises a question that confounds some researchers. In some cases, how Botox works is evident: the toxin can block the signals between nerves and muscles, which is why it can help calm an overactive bladder, say, or a twitching eye, or the facial muscles that make wrinkles more apparent. In other cases, however (with migraines as well as with depression), scientists are flummoxed. They may have noticed that the drug works for a given condition, but they aren't always sure why--in sciencespeak, they don't know what the mechanism is.
The following adverse reactions have been identified during post-approval use of BOTOX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: abdominal pain; alopecia, including madarosis; anorexia; brachial plexopathy; denervation/muscle atrophy; diarrhea; hyperhidrosis; hypoacusis; hypoaesthesia; malaise; paresthesia; peripheral neuropathy; radiculopathy; erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption; strabismus; tinnitus; and visual disturbances.
Around The Eyes – It is common to see wrinkles and creases around your eyes, as the muscles around your eyes are constantly contracting when you talk or smile. The crow’s feet that have formed on the corner of your eyes can be effectively reduced with the help of Botox.  Moreover, a Botox can help diminish the fine creases that have formed under your eyes.
After the injections, the patient will usually lay upright or semiupright on the exam table for about two to five minutes to make sure he or she feels good after the procedure, and then the patient should avoid lying down for two to four hours. If bruising is a concern, it will be important for the patient to avoid taking aspirin or related products, such as ibuprofen (Advil, Motrin) or naproxen (Aleve), if possible after the procedure to keep bruising to a minimum.
"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."
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
Not much. Results begin to show in a couple of days and develop gradually over the course of two weeks. "I tell anyone preparing for a big event to have shots two weeks ahead of time," says Kane. Some observers believe Dysport sets in faster than Botox, but that has not been proven in a study. Patients taking medications that contain aspirin or NSAIDs can develop pinpoint blue bruising. Patients can wear makeup immediately but should avoid heavy workouts for 24 hours, says Carruthers.
Significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of incontinence episodes were observed for BOTOX® (100 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 were also observed. These primary and secondary endpoints are shown in Table 23.
In a recent Facebook Live, our new director Nim Lalvani introduced herself to the migraine community. If you missed our Facebook Live, watch the recording below or read on to learn more about Lalvani’s personal connection to migraine and her plans for the Foundation. [embed]https://www.facebook.com/americanmigrainefoundation/videos/290329171553466/[/embed] In the short time that Lalvani has worked at AMF, she’s been impressed by the strong and vibrant community of doctors, patients and advocates. Lalvani’s background is in public health, and she has dedicated her career to patient engagement. She has worked in the nonprofit and patient advocacy spaces for more than 12 years, helping patients at both the national and international level. “I've specifically focused my career on designing and providing the rights tools and resources for patients at the times that they need it most,” she shared, adding that her goal is to amplify patients’ voices in research and therapeutic development.
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.

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).
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.
Botox prevents migraine headaches before they start, but takes time to work. “I look to the second and third treatments to maximize effects,” says Dr. Andrew Blumenfeld. “Patients see increasing benefit with an increase in the number of treatment cycles.” One treatment lasts for 10-12 weeks, and patients reported that two Botox treatments reduced the number of headache days by approximately 50%.
For most of our guests, the effects of the treatment can last anywhere from 3-6 months. Many factors can influence how long the effects last. As the product wears off, muscle action returns gradually, & the previously treated lines & wrinkles may begin to reappear, and need to be treated again. With repeated treatment, the lines and wrinkles often appear less severe than before, as the muscles are being trained to relax.Some of these factors that may shorten or lengthen the effects include:
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women. In animal studies, administration of BOTOX during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see Data)].

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In some cases known as off-label use, doctors are safely administering it for conditions other than what it is officially approved for, including prostate issues, and eye-crossing (known medically as strabismus) cerebral palsy—which had my jaw on the floor. Rowe even went on to tell me it's the drug of the twenty-first century. "It's like Tylenol or aspirin," he marveled to SELF. "It's what penicillin was in the mid-twentieth century."
Botulinum toxin injections are one approach to the treatment of muscle spasticity. These injections can be given with ease and have minimal side effects. They can also be used in very focal spasticity problems that involve a few muscle groups. This treatment may not be right for some patients, such as patients with severe, widespread muscle spasticity, and patients with permanent muscle contractures that have become rigid.
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spas ticity with BOTOX (3% at 251 Units-360 Units total dose), compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, up per respiratory tract infections were also reported more frequently as adverse reactions in pati ents treated with BOTOX (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%). In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse event in patients treated with BOTOX (2% at 300 Units to 400 Units total dose) compared to placebo (1%).
Sometimes, because of these policies, patients are put on meds that are not approved by the FDA for the treatment of migraines, like the antidepressant amitriptyline and the high blood pressure drug verapamil. “In my experience, [verapamil is] not very effective,” says Elizabeth Loder, chief of the headache division at Brigham and Women’s Hospital in Boston and the former president of the American Headache Society. For the insurance companies, that doesn’t seem to matter. “It’s frustrating to patients, especially when it seems like some of the treatments that they’re required to try have a lot of side effects and haven’t really been tested that carefully for migraines.”

Botox gained popularity and notoriety as a wrinkle reducer in the late 1990s and early 2000s. But it wasn’t long before researchers recognized the potential of Botox for treating medical conditions, too. Today it’s used to treat problems such as repetitive neck spasms, eye twitching, and overactive bladder. In 2010, the FDA approved Botox as a preventive treatment option for chronic migraines.

I don’t know what’s harder, being a mom or living with migraine. Having both can be overwhelming. Over the years, as a stay-at-home mom of two and chronic migraine fighter, I have learned to adapt my life and my children’s lives to migraine. I alter my family’s schedule around my children’s naps, meals and moods, while also keeping in mind my migraine attacks, sensitivities, triggers and abilities.
The efficacy and safety of BOTOX for the treatment of primary axillary hyperhidrosis were evaluated in two randomized, multi center, double-blind, placebo-controlled studies. Study 1 included adult patients with persistent primary axillary hyperhidrosis who scored 3 or 4 on a Hyperhidrosis Disease Severity Scale (HDSS) and who produced at least 50 mg of sweat in each axilla at res t over 5 minutes. HDSS is a 4-point scale with 1 = “underarm sweating is never noticeable and never interferes with my daily activities”; to 4 = “underarm sweating is intolerable and always interferes with my daily activities”. A total of 322 patients were randomized in a 1:1:1 ratio to treatment in both axillae with either 50 Units of BOTOX, 75 Units of BOTOX, or placebo. Patients were evaluated at 4-week intervals. Patients who responded to the first injection were re-injected when they reported a re-increase in HDSS score to 3 or 4 and produced at least 50 mg sweat in each axilla by gravimetric measurement, but no sooner than 8 we eks after the initial injection.
"Neurotoxins and facial fillers are my most popular injectable treatments," notes Zeichner. "Neurotoxins like Botox and Dysport relax muscles under the skin that can lead to folding and lines, specifically frown lines between the eyebrows. Facial fillers are my favorite cosmetic procedure in the office—there's really an art to it. I exclusively use hyaluronic acid fillers because they are safe and long-lasting."
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says that step therapy is driven by a single motivator: saving costs. Hoffman, who’s written about the legal and ethical implications of step therapy, says that sometimes step therapy can have sensible outcomes, like pushing patients to take generics instead of brand-name drugs. But these policies can also keep doctors from prescribing the more expensive drugs of choice, forcing patients to take medications that are less effective or have worse side effects.

Another factor to consider, more high volume practices have more patient incentives from Allergan and the other manufacturers. My patient's receive rebates from the company, instant savings at the checkout, and regular reminders about upcoming treatments and specials that are sponsored by Allergan. This program is only available to the nation's busiest, most successful practices.
Duration of response was calculated as the number of days between injection and the date of the first visit at which patients returned to 3 or 4 on the HDSS scale. The median duration of response following the first treatment in BOTOX treated patients with either dose was 201 days. Among those who received a second BOTOX injection, the median duration of response was similar to that observed after the first treatment.
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.
"I have treated people with profound migraine headaches and it turns them right off," says Dr. Matarasso. "If you feel it coming on, it stops it, reducing the severity as well as the duration. I had a patient [who was] in college who had unremitting migraine headaches. She changed her diet, she changed her birth-control pill, she had acupuncture. I finally said to the mother, 'We need to try Botox,' and it has been a complete life-changing event for this woman."
Allergan says Botox is well established as a drug and that the benefits and risks of toxins are well understood. "With more than 25 years of real-world clinical experience ... approximately 3,200 articles in scientific and medical journals, marketing authorizations in more than 90 markets and many different indications, Botox and Botox Cosmetic are [among] the most widely researched medicines in the world," an Allergan rep wrote in an emailed statement.
Botox comes as a crystalline substance from the manufacturer, which then has to be reconstituted with saline or another liquid. Practitioners add varying amounts of liquid when reconstituting it. Although there is no right or wrong amount of liquid to add, most physicians add about 2 mL-3 mL (about a half a teaspoon) of liquid to each vial. Some add quite a bit more, which can lead patients to think they are getting more Botox when, in reality, they are getting the same or less amount of Botox than samples reconstituted in a stronger way. It is the total dose of medication, not the volume of liquid, that leads to the desired effect.
First of all, for those who aren't familiar with migraines, they're different from headaches. Headaches are unpleasant, too, but are typically less severe than migraines and don't usually present with other symptoms besides the pressure and aching in the head. Migraines, on the other hand, can be much more intense and often come with nausea, seeing spots, vomiting, extreme fatigue, sensitivity to light and sound, and more.
Results will be evident within three to 10 days. Photographs may be taken before the procedure so that patients can check their results themselves rather than relying on their memory. It is surprising to see how many people do not recall how they looked before the procedure and are amazed at the difference when shown a picture. Prior to having the procedure done, the patient should realize that Botox does not actually erase lines but relaxes them. What this means is that deeper lines will become somewhat less deep and superficial lines will nearly disappear. This can be likened to the act of steaming a garment's wrinkles rather than ironing them.
Botulinum toxin is a purified substance that's derived from bacteria. Injections of botulinum toxin block the nerve signals to the muscle in which it was injected. Without a signal, the muscle is not able to contract. The end result is diminished unwanted facial wrinkles or appearance. Commonly known types of botulinum toxin type A injections include Botox®, Dysport® and Xeomin®.
The Allergan Foundation is proud to support charitable organizations and programs having a Bold impact on communities where Allergan employees live and work. Community Grant applications are considered annually from qualified U.S.-based tax-exempt public charities with innovative and leading programs and services, well-defined goals, a commitment to maximizing resources, and a reputation for meeting objectives and reporting measured results. The Allergan Foundation is primarily focused on supporting programs that improve the health and well-being of our communities.
Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Alternatively, bruising could occur, though is less likely, says Rowe, especially in the hands of an experienced doctor. While he says it's "dumb luck" whether or not one bruises from an injection, he also notes that good technique helps reduce the chances. Sobel says that "if you inject [the needle with Botox] too deep, very often you can hit a blood vessel and bruise." What you do after the injection can also make a difference: Take care not to rub or massage the treated areas, as this can cause the toxin to migrate.
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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