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.
The migraines started later in life, before my lupus diagnosis. While sometimes they’d come out of the blue or I’d wake up with them, other times I’d see them coming. From a neurologist’s suggestion, I learned some of my “triggers” such as weather changes (specifically, drops in barometric pressure and incoming storms), hormonal changes and dairy. This past year I significantly reduced my dairy intake and although that didn’t eliminate the migraines, if I did eat dairy, I was sure to get one. Many of my migraines would also start as tension headaches. My neck is always extremely tight and eventually the constant tightness causes a migraine. Due to this, my old rheumatologist suggested taking a muscle relaxer at the beginning of a headache or before bed to keep my muscles from tensing up overnight and preventing a migraine. It worked sometimes… but definitely not enough.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
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.
"For a senior leadership team that has presided over significant value destruction due in no small part to a series of poorly thought out transactions and unforced errors, entrusting the same leadership team with the task of driving value recovery via further M&A is hardly confidence inspiring in our view, to say nothing of the message it sends to shareholders regarding accountability (or more notably lack thereof)," Piper Jaffray analyst David Amsellem wrote in a note on Wednesday.

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).


The safety and effectiveness for the treatment of anatomic regions other than the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC have not been established in controlled clinical studies
Potential Botox side effects include pain at the injection site, infection, inflammation, swelling, redness, bleeding and bruising. Some of these symptoms may indicate an allergic reaction; other allergy symptoms are itching, wheezing, asthma, a rash, red welts, dizziness and faintness. Tell your doctor immediately if you have any breathing issues or a faint or dizzy feeling.
After the injection moves from the dermis and into the desired muscle, the nerves there are blocked—rather, their synapses, are blocked—by the Botox. So even though your brain my fire and signal for your body to move a particular muscle, Botox effectively blocks that firing and keeps the muscle from moving. The injected muscle can no longer contract, which causes the wrinkles to relax and soften, and also helps prevent new ones from forming.
Fine lines, frown lines, how-did-those-get-there lines. Whatever you call them, a few minutes of Botox can smooth wrinkles on your forehead, in-between your eyes, and crow’s feet. This is a non-invasive FDA-approved treatment that requires zero downtime, so you can come in and erase those signs of aging on your lunch break. Using a very fine needle we inject Botox intothe facial muscles responsible for those annoying wrinkles, totally relaxing them and reducing their ability to contract. Don’t worry, you’ll be out the door and on your way to feeling refreshed and radiating confidence in no time.
There are no limits on therapy or activity after the session. For patients that don’t normally use a device to help them walk, at first it may seem like their walking has gotten worse. They need some time to get used to the feeling of the sudden change in the way their muscle contracts when they walk. This most often improves quickly over one to two weeks. Some very young children may have discomfort in their heel cord from rapid stretching. The child may limp or refuse to put weight on it. Again, this most often resolves quickly in the first week.
BOTOX is administered about every three months, and must be injected at the site of each nerve trigger, relaxing the surrounding muscles so that they won’t compress the nerve and trigger a migraine. It is a potent drug, and we only recommend using it if other preventative treatment options haven’t helped you. It is generally only administered to patients who have at least 14 headaches a month, or don’t respond to other treatments.
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.
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 safety and effectiveness for the treatment of anatomic regions other than the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC have not been established in controlled clinical studies
With depression, Rosenthal and Finzi think it may relate to what's known as the facial-feedback hypothesis, a theory stemming from research by Charles Darwin and further explored by the American philosopher and psychologist William James. The theory posits that people's facial expressions can influence their mood. Lift your face into a smile and it may just cheer you up; if you can't frown or furrow your brow in worry, perhaps you won't feel so anxious or sad.
My patients who do respond say that it is absolutely worth it. For people who can’t get their headaches under control with the usual medications, or who suffer from problematic side effects from those drugs, Botox can be a great option. For many of my patients, it has reduced their medication needs and restored their ability to function in their jobs and families.

Children do very well after having this procedure in our clinic and are not upset when they leave. We rarely use sedation. We use distraction and a quick injection method instead. In rare cases, localization of a muscle may be needed using an electromyograph (EMG) machine or electric stimulator. If this is needed we will discuss this before scheduling the injections.
Last time I went in for my Botox treatment, my doctor asked me if I wanted to try Aimovig. Amgen and Novartis, the two manufacturers, were offering two free injections before I could access the drug through my health insurance. I declined. I didn’t want to start a new treatment that I’ll likely be booted from in a few months because of how expensive it is. Plus, the Botox is working great. I just wish I could have gotten it when I first went to see a migraine specialist, two and half years ago.

Now, thanks in large part to off-label use, Botox--the wrinkle smoother that exploded as a cultural phenomenon and medical triumph--is increasingly being drafted for problems that go far beyond the cosmetic. The depression suffered by Rosenthal's patient is just one example on a list that includes everything from excessive sweating and neck spasms to leaky bladders, premature ejaculation, migraines, cold hands and even the dangerous cardiac condition of atrial fibrillation after heart surgery, among others. The range of conditions for which doctors are now using Botox is dizzying, reflecting the drug's unique characteristics as much as the drug industry's unique strategies for creating a blockbuster.
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

Unopened vials of BOTOX should be stored in a refrigerator (2° to 8°C) for up to 36 months. Do not use after the expiration d ate on the vial. Administer BOTOX within 24 hours of reconstitution; during this period reconstituted BOTOX should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX should be clear, colorless, and free of particulate matter.
When the deal with Teva closed in August 2016, it left Allergan with $40 billion to spend. Some of that went to repurchase shares, while some went to a series of acquisitions that totaled about $6.5 billion. One of the bigger deals was for a company developing treatments for NASH, a liver condition that Saunders said would become "one of the next epidemic-level chronic diseases we face as a society."
Many times, effects on spasticity are longer lasting. It is not clear if this is due to breaking down patterned movements (many muscles contracting together rather than singly) or from allowing weak muscles to get stronger over time (that were overpowered before by more spastic muscles pulling against them). It is vital to have close follow-up after the injections to figure out the best course of treatment.
Shah says that it’s harder to treat wrinkles with just Botox as they get more and more ingrained into the face. “Some people may need just a few injections, but some may require more treatments, such as laser treatments or a series of smaller procedures, which are going to cost more. Whereas if they came in five years earlier, I may have just been able to use Botox to get the same effect,” she says.

"The cost for a procedure depends on two main factors," explains Joshua Zeichner, MD, a board-certified dermatologist. "First, different products cost different amounts because of the technology that goes into their manufacturing. In addition, the cost depends on the fee of the injector. If you are seeing a sought-after, skilled injector, you may be paying a premium for that treatment. Especially when getting injectable fillers, your treatment is dependent on the skill and aesthetic of your injector. I do not recommend compromising here or purchasing a deal on websites like Groupon."
“I see a lot of patients who come in from sun damage, or who have creases in their foreheads, more lines around the sides of their mouths, crow's feet, and wrinkles on the side of their nose,” Shah says. “At this age, a dermatologist can inject Botox in the right places to help train a person’s face to no longer fall into that habit, which can help decrease the odds that they’ll develop permanent wrinkles in those spots later on.”
I love talking about migraines. I don't do it to be a downer; I do it because talking about dealing with my chronic migraines may lead to hearing tips from another fellow sufferer, and I've tried nearly everything at this point. I've dealt with migraines for almost two decades, and as anyone who deals with them knows, having a variety of remedies in your toolbox is crucial when the pain hits.
Study 2 compared 3 doses of BOTOX with placebo and included 91 patients [BOTOX 360 Units (N=21), BOTOX 180 Units (N=23), BOTOX 90 Units (N=21), and placebo (N=26)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone) who were at least 6 weeks post-stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimis, flexor carpi radialis, flexor carpi ulnaris, and bic eps brachii (see Table 27).
Dr. Starling says the FDA approval indicates that the anti-CGRP treatments are ideal for individuals with episodic migraine who have four to 14 headache days per month, and people with chronic migraine who have 15 or more headache days per month. Clinical trials are also being conducted to see if anti-CGRP antibodies are effective for the treatment of cluster headache. “The initial studies have demonstrated that it’s likely effective for cluster headache patients,” Dr. Starling says. The FDA’s approval of these medications has been incredibly meaningful for the migraine community. “The migraine community is feeling like they’re relevant—that they’re being seen, heard and taken seriously,” Dr. Starling says. “There are many people who are working hard to develop more treatment options until we can address every patient who has migraine, and eventually find a cure.”
In the case of Botox, doctors who experiment off-label say they do so because they're looking for better treatment options for their patients. "In my 30 years of medical practice, Botox is one of the most impactful treatments I had ever seen," says Dr. Linda Brubaker, dean and chief diversity officer of the Loyola University Chicago Stritch School of Medicine, who independently studied Botox for overactive bladder before the FDA approved it for that condition in 2013.
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].

Step therapy is largely unregulated both at the state and federal level, though individual states have started to pass legislation to limit step therapy and protect patients: 19 US states, including California, Mississippi, and Illinois, have laws that require insurance companies to grant certain exemptions or to review appeals from doctors within 72 hours so patients can get a waiver. But even then, getting a waiver isn’t always easy.
In 2005, the national average cost of a BOTOX® injection was just over $375. However, the cost of BOTOX® treatment varies from area to area. In 2005, the northeastern United States had the highest BOTOX® average cost, at just over $500, while the western states had the lowest average, at under $370. It is important to keep in mind that these statistics may be somewhat misleading, as the cost of BOTOX® injections in Los Angeles will almost certainly be higher than BOTOX® treatment price in say, a rural area of Pennsylvania.

Lastly, a Botox treatment does not offer permanent results. Botox is most effective when treatments are carried out at regular intervals before the results fully wear off. On average, the results last for three to four months,  although Botox metabolizes at different rates in different individuals. The first ever Botox treatment you receive may not last as long as subsequent treatments, plus you may require touch-ups two weeks after the procedure as your injector determines the right dosage for you. Over time, however, many patients notice that they can wait longer intervals between treatments as their treated facial muscles weaken.


Recently, there has been an emerging trend of “BOTOX® Cosmetic parties,” in which several people gather at a physician’s house or another location to have BOTOX® Cosmetic injections at a lower cost. While prices for treatment may be somewhat lower at a BOTOX® Cosmetic party than for treatment administered during a normal office visit, the situation may not be ideal. The American Academy of Dermatology and the American Society of Aesthetic Plastic Surgery have both issued warnings against such “parties,” as they have reservations about the ability of the physician to provide a safe and sterile environment outside of their office.
The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan's products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex.
Receiving Botox injections for migraines is a straightforward outpatient procedure. The skin in the area to be injected is cleaned. Most injections are administered in the forehead area, usually above the eyes or where “worry lines” might occur. Because this area may be sensitive or patients may be experiencing hypersensitivity to pain, a topical anesthetic may be applied before the injection.
What are Botox costs and benefits? Hands down, one of the most exciting cosmetic procedures in dermatology is Botox. It’s been over a decade that this miracle injectable has been approved for cosmetic use and the effects have been amazing. With one injection, Botox has the ability to iron out wrinkles and even prevent new ones from forming. Botox is completely safe and the perfect alternative to plastic surgery. Botox has even been shown to lift moods. A recent study showed that Botox had the ability to improve symptoms of depression when injected in the area in between and directly above the eyebrows. Other areas that can be treated with Botox are the crow’s feet, the upper forehead and around the hairline, to give the entire top half of the face a lift. Plus even more good news for Botox users! A new study shows that Botox injections not only get rid of wrinkles, but also make the overlying skin look and feel younger. So that means the overall appearance of your skin will look rejuvenated thanks to Botox injections. While the cost of Botox injections is certainly not cheap, it’s a sure thing and will produce real results that you can be happy with .
In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient, usually defined as an effect that does not last longer than two months. However, there appears to be little benefit obtainable from injecting more than 5 Units per site. Some tolerance may be found when BOTOX is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent.
Marrying ophthalmology to dermatology, Jean and Alistair Carruthers observed that blepharospasm patients who received injections around the eyes and upper face also enjoyed diminished facial glabellar lines (“frown lines” between the eyebrows), thereby initiating the highly-popular cosmetic use of the toxin.[52] Brin, and a group at Columbia University under Monte Keen made similar reports.[53] In 2002, following clinical trials, the FDA approved Botox Cosmetic, botulinum A toxin to temporarily improve the appearance of moderate-to-severe glabellar lines.[54] The FDA approved a fully in vitro assay for use in the stability and potency testing of Botox in response to increasing public concern that LD50 testing was required for each batch sold in the market.[55][56]

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.


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.


The potency Units of BOTOX (onabotulinumtoxinA) for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see WARNINGS AND PRECAUTIONS and DESCRIPTION] .
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspira tion pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.
“Your doctor still has to be willing to do the work of filing a waiver and they don’t get reimbursed for that work, so they don’t like to do it,” Hoffman says. Plus, there’s a federal law called ERISA that exempts certain types of employer-provided health plans, called self-funded plans, from the requirements of state laws. So, for roughly a quarter of Americans who have these health plans, the state limitations to step therapy don’t apply.
According to the PREEMPT paradigm, one injection of 5 units of onabotulinumtoxinA into four sites (total 20 units) into the frontalis muscle is done. The injection points are located by visually drawing a line up from the medial edge of the supraorbital rim. Patients will be injected into the muscle in the upper third of the forehead at least 1 to 2 fingerbreadths above the corrugator injection site. The lateral muscle injection areas are parallel and approximately 1 fingerbreadth lateral to the medial injection site, which is roughly in line with either the midpupillary line or the lateral edge of the cornea, which is the limbus line. In cases in which I am worried about ptosis, I inject the frontalis close to the hairline. In order to reduce the risk of these unwanted effects, injections should be administered in the upper third of the forehead only. The needle should be inserted at a 45° angle superiorly. Because the frontalis is an elevator muscle, weakening can cause brow ptosis or exacerbate preexisting brow ptosis.
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.
BOTOX® treats the symptoms of severe underarm sweating when topical medicines do not work well enough in people 18 years and older. It is not known whether BOTOX® is safe or effective for severe sweating anywhere other than your armpits. BOTOX® treatments temporarily block the chemical signals from the nerves that stimulate the sweat glands, resulting in reduced sweating.
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