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).
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In many children, there are a few muscle groups that can have very active spasticity. A more focal approach to these muscles would be better than a widespread approach. In this case a doctor may advise a nerve block to interrupt the signal to the muscle that is spastic. Once the signal that is carried to the muscle by the nerve is interrupted, the spasticity will decrease.
There are eight types of botulinum toxin, named type A–H. Types A and B are capable of causing disease in humans, and are also used commercially and medically.[3] Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals.[4] Type H is considered the deadliest substance in the world – an injection of only 2 ng can cause death to an adult.[5] Botulinum toxin types A and B are used in medicine to treat various muscle spasms and diseases characterized by overactive muscle. Commercial forms are marketed under the brand names Botox and Dysport, among others.[6][7]
In 2016, the stock price of Tobira Pharmaceuticals stumbled on the release of the top-line data of the Phase 2b CENTAUR study of CVC therapy in NASH because the clinical trial missed its primary clinical outcome of improvement in NASH resolution without worsening of liver fibrosis. However, CVC therapy achieved its secondary clinical outcome of improvement in liver fibrosis without worsening of NASH resolution. The clinical efficacy of CVC on NASH liver fibrosis is currently being further researched in the ongoing Phase 3 AURORA clinical trial.
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.
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.
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.
Key secondary endpoints included Physician Global Assessment, finger flexors muscle tone, and thumb flexors tone at Week 6. The Physician Global Assessment evaluated the response to treatment in terms of how the patient was doing in his/her life using a scale from -4 = very marked worsening to +4 = very marked improvement. Study 1 results on the primary endpoint and the key secondary endpoints are shown in Table 26.

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%).

Each patient has their own goals for treatment of muscle spasticity made in our clinic. These goals can include decreasing pain from muscle spasms. This can be done by reducing both how often and how intense the spasms are. It can also be done by increasing the range of motion of joints to allow improved function. Improvement of range of motion can help to:
Investors have been unhappy with Allergan's stock performance over the last year, and some have expressed interest in seeing the pharma company explore splitting up. On Wednesday, Allergan announced it plans to sell its women's health and infectious disease businesses. The news sent Allergan's stock down 2%, suggesting the move didn't go as far as some would like.
The safety and effectiveness of BOTOX® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX® for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (eg, hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
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.
There were 214 subjects evaluated for the open label period, of which 170 progressed into the randomized, blinded treatment p eriod (88 in the BOTOX group, 82 in the placebo group). Patient evaluations continued for at least 10 weeks post-injection. The primary outcome for the study was a dual endpoint, requiring evidence of both a change in the Cervical Dystonia Severity Scale (CDSS) and an increase in the percentage of patients showing any improvement on the Physician Global Assessment Scale at 6 weeks after the injection session. The CDSS quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS a llots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54). The Physician Global Assessment Scale is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from 4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. Pain is also an important symptom of cervical dystonia and was evaluated by separate assessments of pain frequency and severity on scales of 0 (no pain) to 4 (constant in frequency or extremely severe in intensity). Study results on the primary endpoints and the pain-related secondary endpoints are shown in Table 35.
"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."

Who is injecting your Botox? Injecting Botox is deceptively easy. After all, it looks like the nurse or physician just takes a little fluid and squirts into facial muscles, and Walla ! Perfection! The answer is No! You should choose a specialist with years of experience and the ability to assess your facial features to create the best treatment plan possible. Because when Botox is injected in the wrong place it can produce unwanted side-effects that you might find disturbing. For instance if the injector “chases” a wrinkle across your forehead and it happens to be too close to your central eyebrow then the Botox or Dysport can drift downward inhibiting a muscle that lifts your eyelid resulting in a drooped upper eyelid. I know you don’t want that! Or if the practitioner injects only your “11” frown lines between your brows and does not inject other areas of your brow to balance out the effect then you may get a “boomerang”brow – a “Spock”-like overarched  brow that looks hideous. So like everything else experience counts but more experience usually translates into a more expensive treatment sessions. However, avoiding complications can save you money and aggravation in the long run.
Botulinum toxin exerts its effect by cleaving key proteins required for nerve activation. First, the toxin binds specifically to nerves which use the neurotransmitter acetylcholine. Once bound to the nerve terminal, the neuron takes up the toxin into a vesicle. As the vesicle moves farther into the cell, it acidifies, activating a portion of the toxin which triggers it to push across the vesicle membrane and into the cell cytoplasm.[1] Once inside the cytoplasm, the toxin cleaves SNARE proteins preventing the cell from releasing vesicles of neurotransmitter. This stops nerve signaling, leading to paralysis.[1]
Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.
"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."

But for some conditions, step therapy can be downright harmful. In a 2016 op-ed in The Boston Globe, a patient with ulcerative colitis wrote that his health insurance forced him to try a cheaper treatment for six months, instead of the pricier meds his doctor wanted to prescribe. In those six months, his colon deteriorated so badly it had to be removed.
The one side effect that we most commonly see with Botox for migraine, ironically, is increased headache pain in the days immediately following the injections. Interestingly, some patients have the opposite effect, noticing immediate pain relief. That may be due to an acupuncture-like response, where poking needles into unhappy muscles actually makes them feel better.
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]
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.
Besides the three primary U.S. manufacturers, there are numerous other botulinum toxin producers. Xeomin, manufactured in Germany by Merz, is also available for both therapeutic and cosmetic use in the U.S.[67] Lanzhou Institute of Biological Products in China manufactures a BTX-A product; as of 2014 it was the only BTX-A approved in China.[67] BTX-A is also sold as Lantox and Prosigne on the global market.[68] Neuronox, a BTX-A product, was introduced by Medy-Tox Inc. of South Korea in 2009;[69]

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.

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]


What Other Factors Determine the Cost of Botox? The fixed cost of Botox or Dysport that the doctor pays for the drugs is relatively expensive and therefore that cost is obviously passed along to the patient. The cost of Botox or Dysport injections also depends upon the number of areas that are required to obtain the best results. The more areas that need treatment the greater the amount of injections that will be required to arrive at the most desirable result. Simply put -the more areas that need  treatment the higher the cost of treatment.
When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal develop ment were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 2 times the human dose of 400 Units, based on Units/k g.
Botox costs can vary anywhere from $200 to $400 or more depending on the physician, location, units purchased, desired profit margin, ongoing promotions, etc. Many doctor's offices price Botox based on cost per unit, but others price Botox injections based on the area of the injection. Whether Botox is charged by the unit or by the area might not matter that much if the Botox treatment is effective, but if you want to know exactly how much you are paying for your treatment, you need to know the number of units of Botox per treatment and the cost per unit. (An honest practice will not hesitate to give you this information if you ask.)
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturi ng processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt -Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever be en reported for albumin.
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.
The Botox used for migraines and the Botox used for cosmetic procedures is actually exactly the same. "Basically, young and middle-aged women were getting [Botox] for cosmetic purposes, and that’s the most common person that has migraines, and that’s how they figured out it was helpful," Ravitz tells me. Women were getting Botox for aesthetic reasons and happened to notice relief from their migraine symptoms, and doctors began looking into it as a direct treatment. In fact, women are disproportionately affected by migraines — about 85 percent of chronic-migraine sufferers are women, and the condition affects 28 million in just the U.S.
Other than that, there don’t seem to be any specific groups of people or health conditions that are contraindicated for Botox injections. As with all treatments, general health guidelines apply. People with a healthy body-mass index who are non-smokers, moderate or non-drinkers, and physically active will nearly always tolerate any type of medical treatment well.
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).

Jump up ^ Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K (February 2001). "Botulinum toxin as a biological weapon: medical and public health management". JAMA. 285 (8): 1059–70. doi:10.1001/jama.285.8.1059. PMID 11209178.
When receiving Botox, it’s critical to know what you’re getting and to be sure that you get what you pay for. Usually, the cost of Botox is calculated on a per unit basis. This is the preferred option of many patients and surgeons as you only pay for the units of Botox used to treat any given area. This means that if you only require ten units to correct your forehead wrinkles, you simply pay for ten units at the specified price and that’s it.
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.
In two double-blind, placebo-controlled trials in patients with detrusor overactivity associated with a neurologic condition (NDO-1 and NDO-2), the proportion of subjects who were not using clean intermittent catheterization (CIC) prior to inject ion and who subsequently required catheterization for urinary retention following treatment with BOTOX 200 Units or placebo is shown in Table 9. The duration of post-injection catheterization for those who developed urinary retention is also shown.
The efficacy and safety of BOTOX for the treatment of lower limb spasticity was evaluated in Study 6, a randomized, multi-center, double-blind, placebo-controlled study. Study 6 included 468 post-stroke patients (233 BOTOX and 235 placebo) with ankle spasticity (modified Ashworth Scale ankle score of at least 3) who were at least 3 months post-stroke. A total dose of 300 Units of BOTOX or placebo were injected intramuscularly and divided between the gastrocnemius, soleus, and tibialis posterior, with optional injection into the flexor hallucis longus, flexor digitorum longus, flexor digitorum brevis, extensor hallucis, and rectus femoris (see Table 33) with up to an additional 100 Units (400 Units total dose). The use of electromyographic guidance or nerve stimulation was required to assist in proper muscle localization for injections. Patients were followed for 12 weeks.
Just because not every cosmetic Botox procedure is FDA-approved doesn't mean it's not safe and effective, if done properly. Off-label procedures are still within the standard of care, and there are tons of them. “There are so many non-FDA-approved applications for Botox,” says dermatologist Dendy Engelman, MD. “It can be used to decrease scalp-sweating (which helps prolong blowouts), correct a droopy nasal tip (called nasal-tip ptosis), fix brow asymmetry, minimize bunny lines from wrinkling your nose, decrease skin oiliness, minimize the appearance of pores...” The list goes on and on.
With regard to detection, current protocols using NBC detection equipment (such as M-8 paper or the ICAM) will not indicate a "positive" when samples containing botulinum toxin are tested.[citation needed] To confirm a diagnosis of botulinum toxin poisoning, therapeutically or to provide evidence in death investigations, botulinum toxin may be quantitated by immunoassay of human biological fluids; serum levels of 12–24 mouse LD50 units per milliliter have been detected in poisoned patients.[63]

The bacterium can also be found in the intestinal tracts of mammals and fish and in the gills and organs of crabs and other shellfish. Such naturally occurring instances of Clostridium botulinum bacteria and spores are generally harmless. Problems only arise when the spores transform into vegetative cells and the cell population increases. At a certain point, the bacteria begin producing botulinum toxin, the deadly neurotoxin responsible for botulism.

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