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.
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).
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Botulinum toxin is one of the most poisonous substances known to man. Scientists have estimated that a single gram could kill as many as 1 million people and a couple of kilograms could kill every human on earth. In high concentrations, botulinum toxin can result in botulism, a severe, life-threatening illness. Botulism, left untreated, may result in respiratory failure and death. Despite botulinum toxin being so toxic, Botox is in huge demand.
This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.
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.
Botox often gets a bad rep for leaving patients looking a little frozen, but that's the fault of bad technique, not necessarily the procedure itself, explains Day. "In many places where it's not a trained aesthetic physician doing the injection, it's really just inject by number," she says. The problem with this is that no two faces, or even two sides of a face, are the same. "That cookie cutter, one-size-fits-all approach is what often gives these treatments a bad name," says Day.
Both Aetna and HealthPartners tell The Verge in an email that they don’t require patients to try verapamil specifically. “Verapamil is just one of many options available to treat migraines. Some are FDA-approved, others are not,” says Becca Johnson, a spokesperson for HealthPartners. Patients are required to try other oral medications because they’re either cheaper or not as invasive as getting Botox injections. “The rationale is that these medications are generally effective and safe,” says Ethan Slavin, a spokesperson for Aetna.
Chapman and Bomba-Warczak both think Botox is safe when used correctly, but they say their inboxes quickly filled with messages after their study was published. "We were startled by the number of people who feel they were harmed by these toxins," says Chapman. "We feel these were pretty safe agents. Now it seems that for some people, they believe the toxin can sometimes cause something that may be irreversible. And that's a total mystery."
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.
The number of Botox varies from one area to another which has a direct effect on how much does Botox cost. For example, to remove crow’s feet, it requires at least 5 to 15 units per side while 10 to 30 units for the forehead lines. Therefore, each of the areas has a different volume of Botox necessary to correct the appearance which factors in the overall cost.
Other things to know about Botox treatments: Some providers charge a consultation fee, which is waived if you choose to proceed with the injections but charged if you decline. Also, who is doing the injection? Make sure it’s a trained, certified professional. As in many other things, training and credentials are important. In some practices, a junior employee may perform the procedure for a lesser rate. Make sure that’s what you want.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient, usually defined as an effect that does not last longer than two months. However, there appears to be little benefit obtainable from injecting more than 5 Units per site. Some tolerance may be found when BOTOX is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent.
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
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 I wean patients off of treatment, I do not change the dose but rather delay the treatment cycle to 16 weeks and monitor headaches in the last 4 weeks. If the patient remains well-controlled, I increase the treatment window to 20 weeks, and so on. I use this method to establish the level at which patients need reinjection to prevent breakthrough headaches.11-13
On April 6, 2016, the company announced it would partner with Heptares Therapeutics in a deal valued up to $3.3 billion to collaborate on the development of a subtype-selective muscarinic agonists for Alzheimer's disease and other major neurological disorders. On April 21, the company announced the acquisition of Topokine Therapeutics for at least $85 million, gaining the phase IIb/III compound XAF5 - a treatment for dermatochalasis. On August 2, the company sold its generic drugs business to Teva Pharmaceutical Industries for $33.4 billion and 100.3 million shares of Teva. On August 11, the company announced the acquisition of ForSight VISION5 for more than $95 million. On September 6, the company acquired RetroSense Therapeutics for more than $60 million, gaining the positive photosensitivity gene therapy treatment, RST-001. RST-001 is to be used in retinas in which rod and cone photoreceptors have degenerated over time, causing in increase in the sensitivity of light hitting the retina. On September 20, the company announced the acquisition of Tobira Therapeutics for $1.695 billion and, a day later, the acquisition of Akarna Therapeutics for $50 million. On October 3, the company sold Anda, its generic drug distribution business, to Teva for $500 million. On October 25, the company acquired Vitae Pharmaceuticals, focused on dermatology treatments, for $639 million. On October 27, the company announced it would acquire Motus Therapeutics, a developer of treatments for gastrointestinal disorders, for $200 million. On November 22, 2016, the company acquired Chase Pharmaceuticals for an upfront payment of $125 million.
Medicine to help the patient relax may be given in cases where the patient has not handled shots well in the past. If the patient has another procedure coming up, these shots can often be done at this time. Let the Rehabilitation Medicine office (513-636-7480) know if a procedure or surgery will be done in the future or if sedation is being discussed for injections in the clinic setting.
But it could be something else altogether. In 2008, Matteo Caleo, a researcher at the Italian National Research Council's Institute of Neuroscience in Pisa, published a controversial study showing that when he injected the muscles of rats with Botox, he found evidence of the drug in the brain stem. He also injected Botox into one side of the brain in mice and found that it spread to the opposite side. That suggested the toxin could access the nervous system and the brain.
On Wednesday, Saunders said at a conference that Allergan is planning to sell its women's health and infectious disease businesses, putting more attention on Allergan's four "core" businesses, which are eye care, aesthetics, diseases of the central nervous system, and gastrointestinal conditions. Allergan's stock fell on the news, suggesting investors haven't been appeased yet.
At the recent American Headache Society meeting in Washington DC, Allergan invested heavily in educating the board-certified headache physicians on the most effective injection sites and methods for Chronic Migraine patients. Find one here. Were I to repeat Botox for Migraine, I would absolutely find one of those Allergan-trained doctors and ask them exactly how many Botox for Migraine procedures they’d done.
Aesthetician Mary Schook is anti-Botox because she sees the long-term effects on her clients. “Everyone is always like, ‘Look how great this looks,’ and then there is the long-term and they are like, 'Fix me,'” she says. “Allergan [the company that owns Botox] says one in 100 patients gets eyelid-drop, so I always joke, ‘I must meet one in 100 patients, because everyone I see has that drop.'”
Before I could try Botox, my health insurance — Cigna — required me to try and fail at least two other meds. I tried tricyclic antidepressants, which made me groggy and turned my brain into molasses, and beta blockers, a class of drugs used for high blood pressure and heart problems. (All treatments to prevent migraines are borrowed from other conditions, except a new class of drugs that was just approved by the Food and Drug Administration.) The beta blockers worked for a few months: they slightly reduced the number of migraines and made the headaches more bearable. But late last year, the migraines became chronic again — I had more than 15 in a month. That’s when my neurologist said: “I think it’s time to try Botox.”
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 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.
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.
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.
BOTOX was evaluated in two randomized, multi-center, 24-week, 2 injection cycle, placebo-controlled double-blind studies. Study 1 and Study 2 included chronic migraine adults who were not using any concurrent headache prophylaxis, and during a 28 -day baseline period had ≥15 headache days lasting 4 hours or more, with ≥50% being migraine/probable migraine. In both studies, patients were randomized to receive placebo or 155 Units to 195 Units BOTOX injections every 12 weeks for the 2-cycle, double-blind phase. Patients were allowed to use acute headache treatments during the study. BOTOX treatment demonstrated statistically significa nt and clinically meaningful improvements from baseline compared to placebo for key efficacy variables (see Table 24).
"Botox inactivates the muscle," Rowe tells SELF, "and therefore the muscle doesn't fire and pull on skin, thus reducing animation." However, when I asked Sobel what was happening during the exact incubation, he told SELF that "I'm not sure if anyone can give you an answer&we've noticed that when we inject it, it just takes three of four days for you to see the muscle contract."
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.”
When receiving Botox, it’s critical to know what you’re getting and to be sure that you get what you pay for. Usually, the cost of Botox is calculated on a per unit basis. This is the preferred option of many patients and surgeons as you only pay for the units of Botox used to treat any given area. This means that if you only require ten units to correct your forehead wrinkles, you simply pay for ten units at the specified price and that’s it.
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.
Study 3 compared 3 doses of BOTOX with placebo and enrolled 88 patients [BOTOX 360 Units (N=23), BOTOX 180 Units (N=23), BOTOX 90 Units (N=23), and placebo (N=19)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone and/or finger flexor tone) who were at least 6 weeks post -stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimi s, flexor carpi radialis, flexor carpi ulnaris, and biceps brachii (see Table 27).
Khalaf Bushara and David Park were the first to demonstrate a nonmuscular use of BTX-A while treating patients with hemifacial spasm in England in 1993, showing that botulinum toxin injections inhibit sweating, and so are useful in treating hyperhidrosis (excessive sweating). BTX-A has since been approved for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating of unknown cause), which cannot be managed by topical agents.
Twenty two adult patients, enrolled in double-blind placebo controlled studies, received 400 Units or higher of BOTOX for treatment of upper limb spasticity. In addition, 44 adults received 400 Units of BOTOX or higher for four consecutive treatments over approximately one year for treatment of upper limb spasticity. The type and frequency of ad verse reactions observed in patients treated with 400 Units of BOTOX were similar to those reported in patients treated for upper limb spasticity with 360 Units of BOTOX.
Many people who experience excessive sweating, whether on their hands, hairline, or even under their breasts or butt, are turning to Botox and other neuromodulators (like Xeomin or Dysport). "They help prevent excessive sweating by acting on the sweat glands directly," says NYC board-certified plastic surgeon Z. Paul Lorenc, MD. "The neuromodulator is injected into the sweat glands to relax the muscle and help combat excessive sweating."
In some practices, the cost of the actual product determines the price, but in others, "The cost of the treatment is based on the skill set, not the product," says Day. In other words, seeing a trained aesthetic physician, who has the time and technique to give you tailored, micro injections, might actually be more costly than larger, more formulaic doses.
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.
“I see a lot of patients who come in from sun damage, or who have creases in their foreheads, more lines around the sides of their mouths, crow's feet, and wrinkles on the side of their nose,” Shah says. “At this age, a dermatologist can inject Botox in the right places to help train a person’s face to no longer fall into that habit, which can help decrease the odds that they’ll develop permanent wrinkles in those spots later on.”
Onabotulinumtoxin A (trade name Botox) received FDA approval for treatment of chronic migraines on October 15, 2010. The toxin is injected into the head and neck to treat these chronic headaches. Approval followed evidence presented to the agency from two studies funded by Allergan showing a very slight improvement in incidence of chronic migraines for migraine sufferers undergoing the Botox treatment.
If you are seeking a Botox specialist, I have more than thirty years experience injecting Botox in New York City and New Jersey. I am a recognized oculoplastic surgeon – you can find me on Google as Dr. Joel E. Kopelman. I have authored several peer reviewed articles regarding the efficacy and safety of Botox injections. You can easily make an appointment to see me in consultation at our office +1 (212) 831-8333 to set up a consultation with me in either New York or New Jersey.
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On July 29, 2016, Food and Drug Administration (FDA), of the United States of America approved abobotulinumtoxinA for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. AbobotulinumtoxinA is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. In the United States of America, the FDA approves the text of the labels of prescription medicines. The FDA approves which medical conditions the drug manufacturer may sell the drug for. However, those approved by the FDA to prescribe these drugs may freely prescribe them for any condition they wish, called off-label use. Botulinum toxins have been used off-label for several pediatric conditions, including infantile esotropia.