Botox has also been shown to prevent chronic migraines, but there, it's unclear exactly why Botox works. (For doctors, reaching a firm understanding of how Botox prevents migraines will be tricky, since they don't know for certain what causes the severe headaches in the first place.) "There were multiple clinical trials for migraines, and most of them failed," says Dr. Mitchell Brin, senior vice president of drug development at Allergan and chief scientific officer for Botox. "It took a long time to figure out where to inject and how much." Today people who receive Botox for migraine prevention get 31 injections in different spots on their head and neck. The effects of Botox can last about three to six months depending on the condition.
In the United States, botulinum toxin products are manufactured by a variety of companies, for both therapeutic and cosmetic use. A U.S. supplier reported in its company materials in 2011 that it could "supply the world's requirements for 25 indications approved by Government agencies around the world" with less than one gram of raw botulinum toxin. Myobloc or Neurobloc, a botulinum toxin type B product, is produced by Solstice Neurosciences, a subsidiary of US WorldMeds. AbobotulinumtoxinA), a therapeutic formulation of the type A toxin manufactured by Galderma in the United Kingdom, is licensed for the treatment of focal dystonias and certain cosmetic uses in the U.S. and other countries.
Botox is said to decrease the frequency of migraine days by an average of 50 percent for those who suffer chronically (people who experience 15 or more headache days per month). After going through hell with my insurance to get approval, I scheduled an appointment with New York City neurologist and pain-management specialist Risa Ravitz. She was kind enough to speak with me about the wonders of Botox while we did my first procedure in June 2017.
Most insurance providers now cover the expense of Botox injections when they’re used to treat chronic migraines. If you don’t have insurance, or your insurance won’t cover the cost of the procedure, it may cost you several thousand dollars. Before you begin receiving injections, talk to your insurance company. In some cases, they may require you to undergo other procedures or tests before they will cover the costs of Botox treatments.
Botulism toxins are produced by bacteria of the genus Clostridium, namely Clostridium botulinum, C. butyricum, C. baratii and C. argentinense, which are widely distributed, including in soil and dust. As well, the bacteria can be found inside homes on floors, carpet, and countertops even after cleaning. Some food products such as honey can contain amounts of the bacteria.
Unlike a face lift or other kind of invasive facial rejuvenation procedure, treatment takes minutes and requires zero downtime. Using a very fine needle, Botox is injected into the facial muscles that are responsible for unsightly wrinkles and fine lines and relaxes the muscles. The ingredients in Botox block the signal from the nerve to the muscle, and therefore reduce it’s ability to contract, and form unsightly wrinkles.
“Your doctor still has to be willing to do the work of filing a waiver and they don’t get reimbursed for that work, so they don’t like to do it,” Hoffman says. Plus, there’s a federal law called ERISA that exempts certain types of employer-provided health plans, called self-funded plans, from the requirements of state laws. So, for roughly a quarter of Americans who have these health plans, the state limitations to step therapy don’t apply.
Sharona Hoffman, professor of law and bioethics at Case Western Reserve University School of Law, says that step therapy is driven by a single motivator: saving costs. Hoffman, who’s written about the legal and ethical implications of step therapy, says that sometimes step therapy can have sensible outcomes, like pushing patients to take generics instead of brand-name drugs. But these policies can also keep doctors from prescribing the more expensive drugs of choice, forcing patients to take medications that are less effective or have worse side effects.
The biological blocking powers of Botox are used to treat migraines, muscular disorders, and some and bowel disorders. It can treat muscle stiffness, muscle spasms, overactive bladder, or loss of bladder control, too. It's also used to stop excessive sweating. "Botox blocks glands the same way it blocks nerves in muscles," Sobel tells SELF. However, don't expect to stop sweating entirely, he says. "You've got to sweat somewhere." What's more, Botox will last far longer in these sweaty situations since the glands are far smaller than the muscles treated, says Rowe.
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.
When asked how often he turns people away, Dr. Matarasso says: “I turned someone away today. I had a gentleman come in, he was an appropriate candidate anatomically, he had some deep lines in his forehead, but his expectations were unrealistic. He wanted every line erased, and I said, ‘No, you are going to look a little mask-like.’ I gave him a brochure and said, 'Go home and think about it.'”
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.
In a long term, open-label study evaluating 326 cervical dystonia patients treated for an average of 9 treatment sessions with the current formulation of BOTOX, 4 (1.2%) patients had positive antibody tests. All 4 of these patients responded to BOTOX therapy at the time of the positive antibody test. However, 3 of these patients developed clinical resistance after subsequent treatment , while the fourth patient continued to respond to BOTOX therapy for the remainder of the study.
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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.
The migraines started later in life, before my lupus diagnosis. While sometimes they’d come out of the blue or I’d wake up with them, other times I’d see them coming. From a neurologist’s suggestion, I learned some of my “triggers” such as weather changes (specifically, drops in barometric pressure and incoming storms), hormonal changes and dairy. This past year I significantly reduced my dairy intake and although that didn’t eliminate the migraines, if I did eat dairy, I was sure to get one. Many of my migraines would also start as tension headaches. My neck is always extremely tight and eventually the constant tightness causes a migraine. Due to this, my old rheumatologist suggested taking a muscle relaxer at the beginning of a headache or before bed to keep my muscles from tensing up overnight and preventing a migraine. It worked sometimes… but definitely not enough.
In recent years, a number of high-profile lawsuits have been brought against Allergan in which plaintiffs claimed that off-label uses--for ailments including a child's cerebral-palsy symptoms, for instance, or an adult's hand tremors--resulted in lasting deleterious side effects. Still, the drug's acceptance in a growing number of doctors' offices worldwide, and its revenue growth, show no signs of slowing.
Absolutely. Botox (and competitors like Dysport and Xeomin, which will be widely available next January) are highly purified toxins that can temporarily erase or reduce horizontal forehead lines, vertical frown lines, and crow's-feet. "The injections slow muscles that contract hundreds of times a day, eventually etching lines in the skin," says New York City plastic surgeon Michael Kane, author of The Botox Book (St. Martin's Press). Botox can also lift the corners of the mouth that sag with age, smooth out the "pin cushion" look in some chins, soften smoker's lines around the mouth, and soften vertical neck cords.
It will not affect the nerves that cause sensation, or make you feel numb. When it is used correctly, it can lift the brow to give an appealing and sincere look. "But if too much is injected in the danger zone—the horizontal lines in the forehead—you can look Spocked, as in Spock from Star Trek," says Jean Carruthers, a Vancouver eye surgeon who, with her husband, Alastair, coauthored the first paper on the cosmetic benefits of Botox in 1989. That's why it's important to be treated by an experienced doctor who can judge the size of your muscles and how much Botox you will need.
Now Allergan hopes to replicate the findings on a larger scale, and the company is currently running its own Phase 2 clinical trial. If its results are in line with Rosenthal and Finzi's, it would be huge, paving the way for Botox to obtain official approval for the drug as a depression treatment. That wouldn't change anything for doctors, of course--they can already prescribe it off-label, and some do, with great results--but it would allow Allergan to begin marketing Botox for depression, a change that could dramatically increase its adoption and sales.
The most frequently reported adverse reactions following injection of BOTOX® for Chronic Migraine vs placebo include, respectively: neck pain (9% vs 3%), headache (5% vs 3%), eyelid ptosis (4% vs < 1%), migraine (4% vs 3%), muscular weakness (4% vs < 1%), musculoskeletal stiffness (4% vs 1%), bronchitis (3% vs 2%), injection-site pain (3% vs 2%), musculoskeletal pain (3% vs 1%), myalgia (3% vs 1%), facial paresis (2% vs 0%), hypertension (2% vs 1%), and muscle spasms (2% vs 1%).
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.
Over the next three decades, 1895-1925, as food canning was approaching a billion-dollar-a-year industry, botulism was becoming a public health hazard. Karl Friedrich Meyer, a prodigiously productive Swiss-American veterinary scientist created a center at the Hooper Foundation in San Francisco, where he developed techniques for growing the organism and extracting the toxin, and conversely, for preventing organism growth and toxin production, and inactivating the toxin by heating. The California canning industry was thereby preserved.
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.
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My patients who do respond say that it is absolutely worth it. For people who can’t get their headaches under control with the usual medications, or who suffer from problematic side effects from those drugs, Botox can be a great option. For many of my patients, it has reduced their medication needs and restored their ability to function in their jobs and families.
This is where Botox comes into play. When you get consistent Botox injections, you prevent potential wrinkle formations from getting deeper or worse. Botox limits the range of facial muscle movement (when done skillfully, your face will not get that frozen look) so that wrinkles don't worsen over time. If you have a bad habit of frowning or lifting your brows for no reason, consistent Botox injections can also help your face kick these bad habits and therefore prevent any potential lines from getting etched in your skin. Getting frequent Botox injections may also help relax your facial muscles so that you don't need as a high a dose or as frequent as an injection to maintain your results.
Treatment with BOTOX and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a conseq uence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing [see Spread Of Toxin Effect].
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Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
Botox lasts only around three months (or more when you first start getting injections), so get ready to go in for maintenance every three to six months. Because it’s only meant to temporarily relax your muscles, it wears off over time, and you’ll notice your wrinkle start to appear again. “As skin ages, the skin loses elasticity and collagen breaks down, so constant muscle and skin contraction can create more permanent creases (wrinkles). Within a few months of injecting the botox, the body makes new acetylcholine receptors, and the nerves are able to conduct their impulses again,” Dr. Shainhouse explains. “You must use neurotoxins continuously in order to reduce muscle movement and prevent long-term skin creasing.” Find out more secrets from dermatologists about how to prevent and treat wrinkles.
University-based ophthalmologists in the USA and Canada further refined the use of botulinum toxin as a therapeutic agent. By 1985, a scientific protocol of injection sites and dosage had been empirically determined for treatment of blepharospasm and strabismus. Side effects in treatment of this condition were deemed to be rare, mild and treatable. The beneficial effects of the injection lasted only 4–6 months. Thus, blepharospasm patients required re-injection two or three times a year.
Significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of incontinence episodes were observed for BOTOX® (100 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction were also observed. These primary and secondary endpoints are shown in Table 23.
Unremarkable. I mean, that’s a good thing in the MRI-reading world, but I’d like to say my brain is freakin’ remarkable sometimes. Maybe I’m biased. Anyways. Shortly after those tests, the Botox arrived at the office and I was scheduled for my injections. To say I was scared is putting it lightly. Like I mentioned before, I have a complete irrational fear of new medication. Also, I didn’t want my face to look different! So I documented my wrinkles just to see how many would last (if you want, be my guest to check out my embarrassing video). I didn’t have to wait long and before I knew it, I was in a room with my mom, my boyfriend, a neurologist and three needles.
Two years later, Allergan bought Oculinum for $9 million and changed the drug's name to Botox. At the time, Allergan was primarily an ocular-care company that sold products like contact-lens cleaners and prescription solutions for dry eyes, bringing in about $500 million in annual sales. Allergan says it saw Botox as a drug for a niche population: it's estimated that 4% of people in the U.S. have crossed eyes, for which the drug was initially approved, and Allergan made about $13 million in sales from the drug by the end of 1991.
Why Botox works isn’t completely clear. There’s some evidence that it may reduce the production of neurotransmitters related to pain in the areas where it’s injected. There’s also some evidence that it may have a broader effect on the brain’s pain centers, reducing the sensitivity that causes migraine sufferers to react to migraine triggers. While the exact mechanisms are poorly understood, the studies, as well as many of my patients’ experiences, do show a real benefit for many people.
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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, 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.