It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
Two double-blind, placebo-controlled, randomized, multi-center, 24-week clinical studies were conducted in patients with OAB with symptoms of urge urinary incontinence, urgency, and frequency (Studies OAB -1 and OAB-2). Patients needed to have at least 3 urinary urgency incontinence episodes and at least 24 micturitions in 3 days to enter the studies. A total of 1105 patients, whose symptoms had not been adequately managed with anticholinergic therapy (inadequate response or intolerable side effects), were randomized to receive either 100 Units of BOTOX (n=557), or placebo (n=548). Patients received 20 injections of study drug (5 units of BOTOX or placebo) spaced approximately 1 cm apart into the detrusor muscle.
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Over time, the muscles above and between the eyebrows repeatedly contract and tighten, causing wrinkles. Botox Cosmetic works beneath the skin’s surface and targets the underlying muscle activity that causes frown lines and crow’s feet to form over time. Normally when we squint, frown, or make other facial expressions, our nerves release a neurotransmitter chemical, known as acetylcholine. This neurotransmitter binds to receptors within the muscle to make it contract. Wrinkle relaxers like Botox and DYSPORT® work by binding to the acetylcholine receptors, and blocking the signal from the nerve to the muscles.

"Botox is a toxin that is extracted from a certain bacteria. It's been used for a couple of hundred years in medicine. It was first used in neurological conditions rather than cosmetic ones. It was first approved to treat spasms of the face and eye muscles. Only later was it discovered coincidentally that it could world for cosmetic purposes, like wrinkles," he says.
Facelift: What you need to know A facelift aims to make the face look more youthful. The procedure can remove excess skin from the face and smooth wrinkles. However, it may not be suitable for everyone. Complications can occur, for example, infections, especially in people with existing health conditions. Relapse and scarring are also possible. Read now
In double-blind, placebo-controlled chronic migraine efficacy trials (Study 1 and Study 2), the discontinuation rate was 12% in the BOTOX treated group and 10% in the placebo-treated group. Discontinuations due to an adverse event were 4% in the BOTOX group and 1% in the placebo group. The most frequent adverse events leading to discontinuation in the BOTOX group were neck pain, headache, worsening migraine, muscular weakness and eyelid ptosis.
One glaring example took place over the weekend, when someone on Twitter (TWTR) posted a photograph of an injured police officer, with a caption that he’d been “brutalized” by the migrant caravan on its way to the United States. “These pictures do not capture police officers who were brutalized by members of the immigrant caravan making its way toward the U.S. in October 2018,” Snopes explained.
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibo dy) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to onabotulinumtoxinA in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
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.
One of the most beneficial uses of BOTOX\for migraines is that it can serve as an indicator of how effective migraine surgery might be for you. BOTOX stops contracting muscles from irritating triggering nerves. If that gives you relief, you may benefit from surgery to “free up” pressure on those nerves. Using BOTOX may also help identify which nerves could be triggering your migraines, making surgical intervention more targeted.

Selecting the correct injection points is critical to the success of the procedure. These points are first scored with a marking pencil. Your doctor will likely select numerous injection points for each location to be treated. (These points are located where the muscle contracts — not necessarily at the wrinkle you are hoping to erase.) The Botox filler is then injected into the marked points beneath the skin.


Please note, there are no guaranteed results with BOTOX and results may vary from patients to patient. Though BOTOX is not effective for all types of headaches, about 90% of MRC’s patients report that their migraines are less frequent and not as severe after BOTOX treatment. In clinical trials, patients reported seven to nine fewer headaches per month. In a study by A. H. Elkind, P. O’Carroll, A. Blumenfeld, R. DeGryse, and R. Dimitrova, a standard course of treatment brought patients these results:
Baby Botox can be used pretty much anywhere on your face, but it's best to create subtle changes or to erase fine lines. "Something like this is especially nice for an area like the crow's feet, which is a very delicate area where a subtle treatment is more effective," explains Smith. "If someone has very deep folds, micro Botox probably isn't going to cut it. I would offer this to someone with moderate to fine lines."

Strabismus is caused by imbalances in the actions of muscles that rotate the eyes, and can sometimes be relieved by weakening a muscle that pulls too strongly, or pulls against one that has been weakened by disease or trauma. Muscles weakened by toxin injection recover from paralysis after several months, so it might seem that injection would then need to be repeated. However, muscles adapt to the lengths at which they are chronically held,[18] so that if a paralyzed muscle is stretched by its antagonist, it grows longer, while the antagonist shortens, yielding a permanent effect. If there is good binocular vision, the brain mechanism of motor fusion, which aligns the eyes on a target visible to both, can stabilize the corrected alignment.


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.
If going back for additional treatments three or four times a year sounds like a lot of treatments, the good news is that the more Botox treatments you get, the fewer Botox units you'll need. With each repeat Botox session, the frontalis muscle and other facial muscles surrounding Botox injection sites get a little weaker and become "trained" to not contract.
If you have eyelid drooping after a Botox procedure, it is a good idea to let the cosmetic surgeon know because there is a medicine available to help this condition. Any other difficulties, such as difficulty breathing or rashes, should be reported to the surgeon immediately. Bruises are generally gone within one to two weeks, there are other medications available for the treatment of these, such as vitamin K topical treatments (Dr. Holmquist Healthcare CytoActive Post-Procedural Bruise Relief, Revision Skincare Vitamin K Serum, Clinicians Complex Bruise Cream, Glymed Plus Arnica+ Healing Cream).
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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.

Study responders were defined as patients who showed at least a 2-grade improvement from baseline value on the HDSS 4 weeks after both of the first two treatment sessions or had a sustained response after their first treatment session and did not receive re-treatment during the study. Spontaneous resting axillary sweat production was assessed by weighing a filter paper held in the axilla ov er a period of 5 minutes (gravimetric measurement). Sweat production responders were those patients who demonstrated a reduction in axillary sweating from baseline of at least 50% at week 4.

* LS mean change, treatment difference and p-value are based on an analysis using an ANCOVA model with baseline weekly endpoint as covariate and treatment group, etiology at study entry (spinal cord injury or multiple sclerosis), concurrent anticholinergic therapy at screening, and investigator as factors. LOCF values were used to analyze the primary efficacy variable.
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]
It may be necessary for the patient to have additional procedures, such as the use of filler substances (for example, Restylane, Perlane, Juvederm, Sculptra, or Radiesse) in order to plump up the wrinkles that are now relaxed. Additionally, it may be necessary to have two or three sessions of Botox treatment for deeper wrinkles before results become optimal. The area of the crease between the eyes is a particularly ideal area for Botox use in conjunction with filler as these fixed wrinkles don't always respond optimally to Botox alone. There is some controversy about using filler in that area as it may block veins or arteries and result in loss of blood and a scar to the area. Generally, the smaller particle fillers, such as Restylane or Juvederm Ultra, are best in the area between the eyes for this reason.
With the outbreak of World War II, weaponization of botulinum toxin was investigated at Fort Detrick in Maryland. Carl Lamanna and James Duff[42] developed the concentration and crystallization techniques that Edward J. Schantz used to create the first clinical product. When the Army’s Chemical Corps was disbanded, Schantz moved to the Food Research Institute in Wisconsin, where he manufactured toxin for experimental use and generously provided it to the academic community.
Some critics say Botox makes you lose all the personality from your face, leaving you with a significantly less range of motion when you laugh, or get angry or upset. While it’s true that your movement will be restricted, a moderate amount of Botox will still allow you to react and communicate in a lively way. “Botox relaxes the wrinkle-forming facial muscles at the sight of injection, such as crow’s feet, glabella (the ‘furrows’ in between the brows), and frontalis (forehead lines),” Dr. Waibel says. “Botox does not affect other facial muscles that are used for overall facial expressions.”
Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.

Pharmaceutical companies are not without blame. One reason why insurers impose step therapy is high drug prices. Botox, which is made from the toxin of certain bacteria, is much more expensive than other migraine treatments like beta blockers, which are available as generics. Botox costs about $4,800 a year, but with injection fees, treatment can cost up to $10,000 a year. “They could lower the price,” says Loder. “Their goal is to maximize return on investment for their stockholders. That’s not the same thing as maximizing benefits for patients, unfortunately.”
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.
Just like any medical procedure the Botox treatment rarely comes with a few possible side-effects that are temporary. The frequency of complications generally decreases the more knowledge of facial anatomy that your injector possesses and the greater the experience of knowing where and how much to inject.That is not to say that complications can occur in anyones hands but the incidence decreases with greater experience.Allergic reactions to Botox or Dysport is exceedingly rare in my experience.
The frontalis muscle attaches to the skin of the lower forehead and ascends to join the fronto-occipital aponeurosis. The action of the frontalis muscle involves elevation of the eyebrows to produce expressions such as surprise, and can cause deep transverse wrinkles on the forehead. The antagonists for brow depression are the corrugators, procerus, and orbicularis oculi muscles.
It’s not just about Botox, though. Last month, the FDA approved the first migraine-specific drug to prevent the severe headaches. Called Aimovig, the injectable med will cost $6,900 a year, according to The New York Times, plus injection fees. Because of the high costs, experts expect the new drug to be subject to step therapy policies. Stephen Silberstein, the director of the headache center at Jefferson University, told me in 2016 that he wouldn’t be surprised if insurance companies required patients to even try and fail Botox before covering the new meds (there are a few of them under development).
Baby Botox can be used pretty much anywhere on your face, but it's best to create subtle changes or to erase fine lines. "Something like this is especially nice for an area like the crow's feet, which is a very delicate area where a subtle treatment is more effective," explains Smith. "If someone has very deep folds, micro Botox probably isn't going to cut it. I would offer this to someone with moderate to fine lines."

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.
Recently, there have been concerns about retrograde botulinum toxin transmission, meaning that the toxin could travel back to the central nervous system, causing long-term damage. Studies done in Italy by Flavia Antonucci have been mainly on a raw form of the toxin and not any of the commercially available preparations. Additionally, these studies have been performed on animals and with the injection of the toxin to one area and in a concentration of nearly 150 times greater than normal injections for cosmetic indications, which are spread over multiple sites.
Exactly how soon you'll need to return for more Botox injections is really up to you. Some patients prefer to return for a touch up of Botox cosmetic after just three months, or at the very first sign of fine lines and facial wrinkles returning. Others prefer to wait six months or more until the effects of the previous injection have completely faded away.
Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.

Botox is an injectable drug made from a toxic bacterium called Clostridium botulinum. When you eat the toxin produced by this bacterium, it causes a life-threatening form of food poisoning, known as botulism. But when you inject it into your body, it causes different symptoms. It blocks certain chemical signals from your nerves, causing temporary paralysis of your muscles.
Pharmaceutical companies are not without blame. One reason why insurers impose step therapy is high drug prices. Botox, which is made from the toxin of certain bacteria, is much more expensive than other migraine treatments like beta blockers, which are available as generics. Botox costs about $4,800 a year, but with injection fees, treatment can cost up to $10,000 a year. “They could lower the price,” says Loder. “Their goal is to maximize return on investment for their stockholders. That’s not the same thing as maximizing benefits for patients, unfortunately.”
Co-administration of BOTOX® or other agents interfering with neuromuscular transmission (eg, aminoglycosides, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.
Unlike some resurfacing or surgical procedures, after which there is possible pigmentation or scarring, when Botox is done correctly, it can be done on all skin tones. “This is a procedure [and] product that crosses all divides,” says Dr. Matarasso. “Men, women, Caucasian, African-American, Asian, Indian. I don’t think there is a demographic that has not enjoyed the benefit of this product.”
Calcitonin gene-related peptide (CGRP) is a neuropeptide found all over the body, says Dr. Amaal Starling, an Assistant Professor of Neurology at the Mayo Clinic in Phoenix. This neuropeptide attaches to a receptor called a CGRP receptor. CGRP and its receptor are involved in numerous bodily processes—from gastrointestinal movement to the transmission of pain. Over the past few decades, there has been increasing evidence that CGRP plays a role in both migraine and cluster headache. During a migraine attack, researchers have found increased levels of CGRP in patients’ blood and saliva. They discovered migraine medications like sumatriptan reduced levels of CGRP in patients living with migraine. They also found that patients with chronic migraine—meaning 15 or more migraine days per month, eight of which either meet criteria for migraine or are treated with migraine-specific medication—had chronically elevated levels of CGRP. In addition, recent research found that giving a patient with migraine an infusion of CGRP would lead to a migraine-like attack. “All of these studies led to the hypothesis that CGRP and its receptor play a key role in migraine, as well as in cluster headache,” Dr. Starling says.
Dubbed as the “little neurotoxin that could,” by USA Today, Botox now boasts sales of well over $1 billion for its manufacturer, Allergan. Many of us who start to see our migraine-furrowed forehead lines show up in our 30s think: hey, maybe Botox for migraine could help me too. But before you say “heck yes!” at the next Botox party or med-spa, be sure you know what you’re getting into.

Robert Anolik, a board-certified, cosmetic dermatologist explains, "The cost for these types of treatments is widely variable, as every patient needs different amounts and in different areas. It could be a few hundred dollars to a few thousand. For example, a patient may have deepened nasolabial folds (smile lines) requiring multiple syringes of Restylane Defyne. Or a patient could need a subtle lift with a small amount of Restylane-Lyft in the cheeks and mid-face. I find many of my patients will come in consistently for Dysport (Dysport spreads out a bit more, so you're able to get a better global balancing, whereas Botox has a little more of an isolated effect) every three to four months on average, and then we will review what might be needed among the fillers. Often more syringes of filler may be needed at first and then we can maintain over time."


So when I first propositioned my husband about the idea of me getting a bit of Botox for the furrowed brow I've earned from a decade of writing and editing behind a computer screen, he was adamantly against it. And frankly, I was a bit scared too. I mean, isn't Botox poison? As an idealistic 21 year old, it was easy to say that I'd never put that stuff in my body, that "poison." Now, I'm not so sure.

Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. It operates through the following business segments: US Specialized Therapeutics; US General Medicine, and International. The US Specialized Therapeutics segment includes sales and expenses relating to branded products within the United States. The US General Medicine segment involves Central Nervous System; Gastrointestinal; Women's Health; Anti-Infectives; and Diversified brands. The International segment comprises of products sold outside the United States. The company was founded on in 1984 and is headquartered in Dublin, Ireland.
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