Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.
Botox® neurotoxin treatment helps control the symptoms of severe underarm sweating when topical medicines do not work well enough by temporarily blocking the chemical signals from the nerves that stimulate the sweat glands. When the sweat glands don’t receive chemical signals, the severe sweating stops. Botox® injections are expected to temporarily stop the production of excessive sweat in the treated areas only. Sweat continues to be produced elsewhere.
Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure.
Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
The FDA approved such usage in the late 1980s upon the discovery that Botox could stop ailments like blepharospasm (uncontrolled blinking) and strabismus (lazy eye). Doctors have been using Botox for years to successfully treat wrinkles and facial creases. In April 2002, Botox gained FDA approval for treatment of moderate-to-severe frown lines between the eyebrows - called glabellar lines. However, Botox is often used for other areas of the face as well.
The more areas that need treatment the higher the cost of treatment. The reason is also simple – the 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. A second factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport determines the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price for injections you should question whether or not you are receiving a very dilute injection.This dilute mixture typically does not produce the same effect as a more or not concentrated (more expensive) injection and does not last as long.
Though there's still more research to be done on Botox for migraines and doctors aren't yet completely sure why the procedure is effective, they have some ideas. Ravitz tells me, "What [Botox] does is paralyze nerve terminals. Essentially, nerve terminals transmit pain, but they also produce pain substances while they’re doing that, and it completely paralyzes that process." She says that it stops the process of pain patterning and it also relaxes the muscles.
Table 14 presents the most frequently reported adverse reactions in a placebo-controlled, double-blind post-approval 52 week study with BOTOX 100 Units (Study NDO-3) conducted in MS patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition. These patients were not adequately managed with at least one anticholinergic agent and not catheterized at baseline. The table below presents the most frequently reported adverse reactions within 12 weeks of injection.
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.
Botox is a drug made from a neurotoxin produced by the bacterium Clostridium botulinum called botulinum toxin. "It's a poison secreted by the bacteria," plastic surgeon Norman Rowe, M.D., tells SELF. Botulinum toxin has proven to be a successful and valuable therapeutic protein when dosage, frequency of treatment and variety of treated clinical conditions are considered, according to Howard Sobel, M.D., a dermatologist in New York. Basically: when it's done right. When it's done wrong—like, really, really wrong—it can cause "botulism-like symptoms," according to Mayo Clinic, which may include muscle weakness, trouble breathing, speaking or swallowing, bladder control issues, and vision problems. That is "very unlikely," but a more than convincing enough reason not to go bargain hunting for Botox.
Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, diabetes, signs of infection near the injection site, urinary tract infection, inability to urinate, muscle/nerve disorders (such as Lou Gehrig's disease-ALS, myasthenia gravis), seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia), treatment with any botulinum toxin product (especially in the last 4 months).
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.
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.
How Was the Botox Mixed? A factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
Most doctors suggest focusing on the quality of the skin with a proper regimen that includes daily exfoliation and SPF protection, as well regular chemical peels or specialized treatments such as Clear and Brilliant laser resurfacing during this decade. Still, there are exceptions. If constant eyebrow furrowing has resulted in the first signs of an angry crease or premature crow’s feet due to naturally thin skin are a persistent cause of frustration, injectibles can help. But as any good dermatologist will note, there is a caveat: When it comes to Botox and filler, there's a fine line between targeted tweaks and doing too much too soon. Here, in-demand experts share their guidelines for women in their 20s.
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] .
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.”
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.
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Most practices have a flat cost for each injection of BOTOX® Cosmetic, though some will break it down by “units” used per treatment. Flat rates are usually somewhere between $300 and $1000, while per-unit rates are usually around $10-15 per unit. Though the BOTOX® Cosmetic price paid by physicians is normally about $400 for each vial (each vial contains 100 units, or enough for about 4 or 5 treatments), the vial must be used within a few hours of opening, so if the entire vial is not used, the physician will often have to throw the rest out.
Extraocular muscles adjacent to the injection site can be affected, causing vertical deviation, especially with higher do ses of BOTOX. The incidence rates of these adverse effects in 2058 adults who received a total of 3650 injections for horizontal strabismus was 17%. The incidence of ptosis has been reported to be dependent on the location of the injected muscles, 1% after inferior rectus injections, 16% after horizontal rectus injections and 38% after superior rectus injections.
Two double-blind, placebo-controlled, randomized, multi-center clinical studies were conducted in patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition who were either spontaneously voiding or using catheterization (Studies NDO-1 and NDO-2). A total of 691 spinal cord injury (T1 or below) or multiple sclerosis patients, who had an inadequate response to or were intolerant of at least one anticholinergic medication, were enrolled. These patients were randomized to receive either 200 Units of BOTOX (n=227), 300 Units of BOTOX (n=223), or placebo (n=241).
Younger patients have been increasingly hopping on the Botox bandwagon as a preventative measure—even before the wrinkles appear or deepen. That’s why dermatologists can’t recommend the best age to start or try Botox, since it depends on your goals, your facial expressions, and your preference. If all you see when you look at a photo of yourself is that forehead wrinkle instead of your bright eyes or smile, it might make you happier to get the wrinkle taken care of. “Each time we raise our eyebrows, or scowl by bringing our eyebrows together, the wrinkles in these locations get deeper and more numerous. It happens slowly over a long period of time, so you don’t notice it on a daily basis,” Dr. Tutela says. “But if you look at the horizontal wrinkles in your forehead when you are not raising your eyebrows, you will see an increase in these wrinkles when you do raise your brows. If you then hold that raised brow position for 10 seconds, you will notice when you relax, your forehead wrinkles look deeper and more numerous. Botox prevents this from happening.” It’s almost never too early to start a good anti-aging regimen. Learn the most in-demand cosmetic treatments across the US.
BOTOX® Cosmetic targets one of the underlying causes of frown lines, crow’s feet and forehead lines — the repeated muscle contractions from frowning, squinting, smiling and raising the eyebrows over the years. Your specialist will inject these muscles with BOTOX® Cosmetic to temporarily reduce muscle activity. You will begin to notice a visible smoothing of the frown lines between your brows, your crow’s feet lines and your forehead lines.
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.
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.”
As a plastic surgeon, it will never be a major source of income for me, so I choose to make it easy and affordable. We charge $13 per Botox unit. Having said that, though, we have a monthly day of beauty when Botox, facials, and peels are discounted - in the case of Botox, usually to $10 per unit. Currently, because we are welcoming a Nurse Practitioner to our Aesthetic Surgery Center, we are even offering Botox for $7 per unit!
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.
In rare cases, Botox toxin can spread to areas beyond the injection site. If this happens, you may experience muscle weakness, vision changes, difficulty swallowing, and drooping eyelids. To reduce your risk of serious side effects and complications, always make sure Botox is prescribed and administered by a trained healthcare professional who has experience in using Botox.
The best part of Botox is people saying that you look great, but they can’t put their finger as to why. When administered effectively, you’ll look like a brighter, smoother version of yourself, but not plastic-y. To prevent looking frozen, Dr. Tutela says to make sure your dermatologist or plastic surgeon tells you how many units they recommend. Everyone’s face is different and again, there is no magic number, but knowing your starting point will help tailor future appointments, he says. And don’t do anything until you learn the 13 things plastic surgeons will never tell you.
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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.
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.