After an exam by a therapist and doctor, botulinum toxin for focal relief of muscle spasticity can be advised as the best way to address a child's functional problems. The problem muscle groups are identified, and goals for that child are discussed. Then the injection of botulinum toxin can be done if there are no permanent contractures of the muscle groups.
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.
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Currently, there are several anti-CGRP treatments undergoing clinical trials. Some of these treatments involve monoclonal antibodies, which reduce the activity of CGRP, potentially leading to fewer migraine attacks. One of these anti-CGRP monoclonal antibodies, erenumab (Aimovig™), has been approved by the Federal Drug Administration (FDA) and is now available for patients. A second agent, fremanezumab (Ajovy™), was approved in September 2018. A week later, the FDA approved galcanezumab (Emgality™), making it the third anti-CGRP treatment currently on the market. Results from the clinical trials involving anti-CGRP antibodies have shown that about 50 percent of patients will have at least a 50 percent reduction in migraine days. “If you think about someone who has 20 migraine days per month, they have a 50 percent chance of having 10 or less migraine days,” Dr. Starling says. “We think that there are even these super-responders who have a 75 percent response rate, as well as super-super-responders who actually go into remission.” The results from these clinical trials are very promising, Dr. Starling adds. “The adverse events have been very minimal and the efficacy has been very good. It’s all looking up.” Dr. Starling says that although these medications are available, what really needs to be looked at is how to make them truly accessible for patients. Erenumab can cost about $7,000 per year without insurance coverage. “Insurance coverage is very, very key for the majority of our patient population,” she says. “Because the medications just came out on the market, there are still a lot of unknowns about insurance coverage.”
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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.”
An injection of BOTOX is prepared by drawing into an appropriately sized sterile syringe an amount of the properly reconstituted toxin slightly greater than the intended dose. Air bubbles in the syringe barrel are expelled and the syringe is attached to an appropriate injection needle. Patency of the needle should be confirmed. A new, sterile needle and syringe should be used to enter the vial on each occasion for removal of BOTOX.
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Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, general ized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. [See WARNINGS AND PRECAUTIONS]
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."
"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."
In addition to glabellar lines, Botox is used to eradicate crow’s feet, frown lines, and lines and furrows in the forehead. Whereas treating crow's feet and forehead lines with Botox was for many years an off-label use, the toxin has since received FDA approval for both uses. Botox is also approved to treat a variety of medical conditions, including ocular muscle spasms, problems with eye coordination, severe armpit perspiration, migraine headaches, overactive bladder, urinary incontinence related to nerve damage from conditions such as multiple sclerosis and spine injury. Botox is being studied to determine if it might be useful in treating conditions such as knee and hip osteoarthritis, temporomandibular joint disorder (TMJ) and benign prostatic hyperplasia (BPH).
Ratings on RealSelf.com (www.RealSelf.com) show a satisfaction rate of 65% for Botox, which is on par with other treatments such as Restylane, Juvederm, and Perlane and slightly higher than Xeomin and Dysport. Longer-term treatments, such as Ultherapy facial tightening and Liposuction/SmartLipo achieve ratings in the 80% and above area, while others such as CoolSculpting (Zeltiq) achieve ratings in the 70% area. This may reflect upon the short-term nature of all botulinum toxins versus the longer-term nature of these other procedures.
When my babies were little, I never discussed migraine with them. As they grew into preschool and elementary age, I found it necessary to explain it to them. They had seen me experience migraine symptoms for a long time but understood it as just being sick. We went to a migraine walk where we talked about how others cope like I do, and they heard other stories that were similar to mine. They felt empowered that we had fundraised for a disease that affects millions and that we were fighting it as a family and community. My children want to help. Having ways they can help builds their confidence in their ability to take care of me, as I do them. They know to turn the lights off, get ice and talk quietly. I have taught them how to be self-sufficient. I’m so proud of how they take care of themselves and are willing to take care of others. The qualities that they’re learning and displaying will carry them through life.
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In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of urinary incontinence episodes were observed for BOTOX 100 Units at the primary time point of week 1 2. Significant improvements compared to placebo were also observed for the secondary efficacy variables of daily frequency of micturition episodes and volume voided per micturition. These primary and secondary variables are shown in Tables 19 and 20, and Figures 5 and 6.
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.
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.
The correct way to inject Botox is to always customize the treatment plan to solve the aesthetic issues that bother the person. Some patients need only limited areas injected such as the vertical lines between their brows, their “crow’s feet” at the outer aspects of their eyelids, the “bunny” lines that radiate on the sides of their nose, vertical and horizontal lip lines and rarely patients request a correction of their “gummy” smile where their upper gums show when a person smile. Yes, you usually can pay for specific areas of treatment or by the number of units injected. But if you only want single line or area of your forehead injected you may not be satisfied with the results in the end. Why? -because when Botox or Dysport is injected it will weaken only the muscles that are treated, there may be muscles that were not treated that are pulling in an opposite direction that will produce undesirable results(an example of an undesirable effect occurs when treating just the glabella “11” lines between your eyebrows that may produce an overarched brow contour that resembles Mr. Spock.) Therefore, a complete treatment plan that includes all muscle groups should be treated to balance the pull and counter-pull of facial muscles.In addition, injections around the mouth must be performed by an experienced injector because there is the potential for the mouth to droop afterwards which can cause you to drool or may impact your ability to eat, pucker and smile. These adverse effect may last several weeks.
BTX-A has also been used in the treatment of gummy smiles, the material is injected into the hyperactive muscles of upper lip, which causes a reduction in the upward movement of lip thus resulting in a smile with a less exposure of gingiva. Botox is usually injected in the three lip elevator muscles that converge on the lateral side of the ala of the nose; the levator labii superioris (LLS), the levator labii superioris alaeque nasi muscle (LLSAN), and the zygomaticus minor (ZMi).
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.