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In November, the FDA held a two-day hearing asking for expert comment on the agency's rules concerning off-label drug use and marketing. Some said the practice paves the way for scientific progress and gives doctors and their patients much needed alternatives for hard-to-treat medical conditions. Others said that off-label drug use is primarily financially motivated and that it poses a serious threat to public health, particularly when drugs are used experimentally on children.
BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
Most people tolerate the injection discomfort well. But you may want your skin to be numbed beforehand, especially if your palms or soles are being treated for excessive sweating. Your doctor might use one or more of various methods available to numb the area, such as topical anesthesia, ice and vibration anesthesia, which uses massage to reduce discomfort.
So let's talk about it, shall we? And before we do, let's also get one thing out of the way—I've had Botox. And it was free. As a result, I've found myself trying to field questions about the price and popularity of certain treatments, and many times my knowledge on the subject comes up short. To remedy that fact, I decided to do some research into the real, unexaggerated pricing for injections and what each formula and technique will actually do to your face. Below find the answers you may have been looking for but didn't feel comfortable asking.
In some cases known as off-label use, doctors are safely administering it for conditions other than what it is officially approved for, including prostate issues, and eye-crossing (known medically as strabismus) cerebral palsy—which had my jaw on the floor. Rowe even went on to tell me it's the drug of the twenty-first century. "It's like Tylenol or aspirin," he marveled to SELF. "It's what penicillin was in the mid-twentieth century."
The cosmetic benefits came to light in the 1990s by happy coincidence. “The aesthetic indications were purely happenstance,” says board-certified surgeon and clinical professor Seth L. Matarasso, MD, who has been treating his clients with Botox since the 1990s but is not affiliated with the brand. “Dr. [Jean] Carruthers was working with patients with strabismus...[and] with diplopia [double vision], and her patients were coming in and saying, ‘Gee, my wrinkles are better.'" Soon enough, doctors were using Botox for what it is most commonly associated with today — nixing lines.
Botox is so commonplace these days that you can get it done at some gyms and spas, but in these cases, you never know what you’re getting, how old the product is, with what it's mixed, and whether the injector knows what he or she is doing. Dr. Matarasso suggests only getting it done by what he calls the “core four”: a board-certified physician who is either a dermatologist, a plastic surgeon, an ear-nose-and-throat doctor, or an ophthalmologist.
A recent encounter with one of my headache patients got me thinking. I am treating this young woman for chronic migraine with BOTOX injections. She told me that one of her other physicians had been surprised to hear about this use for onabotulinumtoxin A. According to my patient, the gastroenterologist’s words were, “BOTOX for migraines? I’ve never heard of that.”
Since Botox made its first appearance in the med-spa world, a number of similar treatments have also become available. These include Dysport, another Botulinum toxin type A injectable, as well as dermal fillers (which use hyaluronic acid to plump skin) such as Juvéderm, Restylane, and Perlane. The decision to choose between Botox vs Dysport depends largely on the results you're hoping to achieve. For more information, check out the following guides:
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.
"I have treated people with profound migraine headaches and it turns them right off," says Dr. Matarasso. "If you feel it coming on, it stops it, reducing the severity as well as the duration. I had a patient [who was] in college who had unremitting migraine headaches. She changed her diet, she changed her birth-control pill, she had acupuncture. I finally said to the mother, 'We need to try Botox,' and it has been a complete life-changing event for this woman."
In a double-blind, placebo-controlled, parallel group study in adult patients with detrusor overactivity associated with a neurologic condition and restrictive lung disease of neuromuscular etiology [defined as FVC 50-80% of predicted value in patients with spinal cord injury between C5 and C8, or MS] the event rate in change of Forced Vital Capacity ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 6).
As compared to standard-size injections, Baby Botox lowers the risk of your features appearing to be frozen. Take the forehead, for example: "The risk is that you weaken your frontalis muscle, which causes your eyebrows to drop," Darren Smith, a board-certified plastic surgeon in New York City, tells Allure. "If you're getting micro doses of Botox, that's a lot less likely to happen."
In the third study, 25 patients with chronic migraine were injected with 12.5 doses of botox into each trigger point twice, during a period of 3 months. Frequency (main variable), intensity and scales of migraine crises were recorded one month before and one month after the treatment to compare the changes experienced. In addition, side effects were also recorded during the experiment, and they were found to be mild and temporary.
Can you use Botox under your eyes? Botox is often used to treat lines and wrinkles around the eyes and mouth. Can it also reduce dark circles or bags under the eyes? Using Botox under the eyes is not approved in the U.S. and researchers are unsure how well it may work and what side effects may occur. Here, learn about the procedure and its alternatives. Read now
Temporary bruising is the most common side effect of Botox. Headaches, which resolve in 24-48 hours, can occur, but this is rare. A small percentage of patients may develop eyelid drooping. This usually resolves in three weeks. This usually happens when the Botox moves around so you shouldn't rub the treated area for 12 hours after injection or lay down for three to four hours.
The safety and efficacy of onabotulinumtoxinA for CM was demonstrated in the pivotal phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trial. In this trial, patients were treated every 12 weeks whether or not their headaches had returned to baseline levels and the primary outcome period was after two treatment cycles. At baseline, these patients had more than 19 headache days, and after two treatment cycles, their headaches had been reduced by 8 to 9 days per 28 days. The responder rate analysis of the study population shows that about 25% of patients improved by 75% in terms of a reduction of migraine days. In my practice, I usually do three cycles 12 weeks apart, and only if there is no change in headache frequency after this, do I change treatments. In the pivotal trials, the first statistical separation from placebo occurred in the first 4 weeks. There is a small subgroup of patients who fail to respond to the first two treatments and only start to respond after the third treatment.4-10
The most frequently reported adverse reactions following injection of BOTOX for adult lower limb spasticity appear in Table 17. Two hundred thirty one patients enrolled in a double-blind placebo controlled study (Study 6) received 300 Units to 400 Units of BOTOX, and were compared with 233 patients who received placebo. Patients were followed for an average of 91 days after injection.
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).
Since then, several randomized control trials have shown botulinum toxin type A to improve headache symptoms and quality of life when used prophylactically for patients with chronic migraine who exhibit headache characteristics consistent with: pressure perceived from outside source, shorter total duration of chronic migraines (<30 years), "detoxification" of patients with coexisting chronic daily headache due to medication overuse, and no current history of other preventive headache medications.
The results showed that 34% of those who responded and tried Botox said it significantly helped them. Sixteen percent reported a slight benefit. Nine percent stated that it didn’t help at all. Eleven percent stated that they would like to try Botox but it is too expensive. About 10% said they had no plans to try Botox, and 18% said they hadn’t tried it yet.
I always tell my patients that you get what you pay for. However, you need to advocate for yourself and understand what you are getting for your dollars. Ensure that your injector is experienced and properly trained; that you are getting FDA approved Botox Cosmetic from Allergan; and know how many units you receive. As well, a physician's office should maintain a medical record of your treatments so you can optimize and customize your Botox to achieve the best effect and value. Good Luck!
Launched in 2002, Practical Neurology is a publication uniquely dedicated to presenting current approaches to patient management, synthesis of emerging research and data, and analysis of industry news with a goal to facilitate practical application and improved clinical practice for all neurologists. Our straightforward articles give neurologists tools they can immediately put into practice.
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.
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spasticity with BOTOX® (3% at 251 Units to 360 Units total dose) compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients 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%).
The most common side effect of the BOTOX procedure for migraines is neck pain. In clinical trials, 9 percent of patients reported this side effect. Other side effects can include headaches or muscle pain, but these side effects are far less common. If you do experience neck pain, an ice pack can help you manage the discomfort until it dissipates. At Allure Esthetic, we will perform the BOTOX for migraines procedure carefully and correctly.
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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.
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.
Hoffman’s husband’s experience is not unusual. Once a patient gets the more expensive prescription, health insurance providers can still try and push them back to cheaper drugs. Brigham and Women’s Hospital’s Loder says that most health insurance companies stop paying for Botox if it’s not reducing a patient’s migraines by at least 50 percent. “It’s important to keep careful headache diaries and keep careful notes in order to be able to prove to the insurance company that the treatment is worth it,” Loder says. “You’re not home free once they approve it.”
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.
BOTOX for migraines is an innovative, FDA-approved procedure. BOTOX is a unique approach to migraine relief that is proving to be highly effective for many patients living with the condition. Rather than reducing the symptoms of an existing headache, BOTOX works to prevent future headaches, and helps avoid the continued use of powerful prescription pain medications.
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.
The patient’s neck stability, posture, torsion, and symmetry should be assessed to determine whether he or she may be at increased risk for adverse events prior to the first injection cycle. A patient with preexisting neck pain and/or weakness may be at higher risk for exacerbation of the condition upon injection of the occipitalis, cervical paraspinal, or trapezius muscle groups. Patients with smaller frames may be at higher risk for neck weakness. Indicated injection sites can still be injected with minimal side effects and unwanted outcomes as long as correct injection sites are targeted and treatments are administered using a superficial approach with avoidance of the mid and lower cervical regions. The cervical paraspinal muscle group is made up of multiple muscles including the trapezius, splenius capitis and cervicis, and semispinalis capitus. This group of muscles helps support the neck, including extension of the head.
ONABOTULINUMTOXINA is a neuro-muscular blocker. This medicine is used to treat crossed eyes, eyelid spasms, severe neck muscle spasms, ankle and toe muscle spasms, and elbow, wrist, and finger muscle spasms. It is also used to treat excessive underarm sweating, to prevent chronic migraine headaches, and to treat loss of bladder control due to neurologic conditions such as multiple sclerosis or spinal cord injury. The lowest GoodRx price for the most common version of Botox is around $602.89, 19% off the average retail price of $747.02. Compare acetylcholine release inhibitors.
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.
Even though the procedure seems easy, it is still a medical procedure and requires a trained professional to administer the Botox solution. The credentials and experience of the doctors are critical regardless how much does Botox cost in their shop. Remember that a legit procedure is much safer and guarantees the end result which directly protects your investment.
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.