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."
Migraine with visual aura involves visual effects that usually precede the headache and last at least 5 minutes. The visual aura is usually an expanding blinding spot or visual scintillations (shimmering objects in the visual field). Other aura features include reversible symptoms of speech and language difficulty such as word-finding problems and aphasia (inability to express words or comprehend words), sensory phenomena such as tingling in the extremities extending to the face, motor effects such as weakness, and brainstem problems such as unsteadiness and features of cranial nerve dysfunction. These aura symptoms usually last 5 to 60 minutes, can precede or start during the headache, and can also occur without a headache.
So people told me I looked tired, overlooking the grape-size purple bruise smack dab in the center of my forehead. As one RealSelf reviewer wrote: “My head feels too tight, my eyebrow position has dropped enough to lose my nice pretty arch and my eyelids seem hooded. My eyes look smaller.” Now, if it works, looking a bit tired is a small price to pay for a few more days each month of migraine freedom and function. And bruises can be covered with makeup.
Side effects from cosmetic use generally result from unintended paralysis of facial muscles. These include partial facial paralysis, muscle weakness, and trouble swallowing. Side effects are not limited to direct paralysis however, and can also include headaches, flu-like symptoms, and allergic reactions. Just as cosmetic treatments only last a number of months, paralysis side-effects can have the same durations. At least in some cases, these effects are reported to dissipate in the weeks after treatment. Bruising at the site of injection is not a side effect of the toxin but rather of the mode of administration, and is reported as preventable if the clinician applies pressure to the injection site; when it occurs, it is reported in specific cases to last 7–11 days. When injecting the masseter muscle of the jaw, loss of muscle function can result in a loss or reduction of power to chew solid foods.
Some skin care centers advertise low prices for Botox on a "cost per area" basis, advertising prices of $200-$300 for one area. The doctor we spoke to recommends getting price quotes on a "cost per unit" basis, because some places might be quoting lower prices but giving you smaller treatments, which may be less effective and require more frequent visits.
As with any drug, Allergan is legally required to make known Botox's most severe potential side effects, and in 2009 the FDA required Botox to bear a black-box warning--the strongest type of warning label given to any drug--cautioning that there was evidence the drug had been linked to serious side effects. With Botox, this includes effects spreading from the injection site to other parts of the body, causing muscle weakness, double vision and drooping eyelids.
Dr. Matarasso says hardly a week goes by when he doesn’t see a patient with a botched Botox job. Why? People are getting it done by unexperienced, often unlicensed, practitioners who don’t know the shape of the face and how to correctly administer the toxin. “I just had a patient come in the other day who went to an ER doctor, and one that went to a psychiatrist,” he says. “They [also] have these Botox parties and I have seen scarring, significant bruising, not only functional, but aesthetic complications.”
Most doctors who provide cosmetic services such as BOTOX® treatments accept payment by various methods, including cash, personal check, major credit cards, or through arrangements made with an established lending institution. Some practices even offer their own financing plans. Don’t be afraid to inquire about BOTOX® treatment financing during your initial consultation.
It can also be expensive. Depending on your insurance, it can cost quite a lot of money — I've changed insurance providers since I first started, and my first provider was around $330 a month and charged me around $1,000 per Botox round (remember, that's four times a year). My new plan is much more expensive, around $600 a month, but the Botox copay is only $30 each time, so even if Botox is the only medical procedure I need to have done in the year, it made sense to switch.
The use of Botox for migraines was, like many other new applications for the drug, a kind of happy accident. A Beverly Hills plastic surgeon observed that people who got Botox for wrinkles were reporting fewer headaches, paving the way for studies about migraines. Similarly, doctors in Europe were intrigued when they noticed that their patients who got Botox for facial spasms were sweating less than usual.
According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA is administered to one site in the procerus muscle. The procerus injection site is approximately midway between the two corrugator injections. In order to confirm the location of the procerus muscle, the patient is asked to furrow the brow, which will activate the belly of the muscle causing the medial furrowing to occur. Once identified, 5 units of onabotulinumtoxinA is injected superficially into the belly of the muscle at a 90° angle to ensure the injection is administered into the procerus rather than the frontalis. Injections placed too superiorly may inadvertently lead to penetration of the frontalis muscle.
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]
Intradetrusor injection of BOTOX is contraindicated in patients with overactive bladder or detrusor overactivity associated with a neurologic condition who have a urinary tract infection. Intradetrusor injection of BOTOX is also contraindicated in patients with urinary retention and in patients with post-void residual (PVR) urine volume >200 mL, who are not routinely performing clean intermittent self-catheterization (CIC).
OnabotulinumtoxinA is the only treatment approved by the United States Food and Drug Administration for the prevention of headaches in adult patients with chronic migraine (CM). CM assessment involves a detailed history to rule out secondary sources of headache, establish migraine features, and assess the total number of headache days. In order to diagnose migraine, the patient should have had at least five attacks that involve migraine features, as outlined below. In adults, untreated attacks usually last 4 or more hours.
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.”
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.
In May, hedge fund Appaloosa Management, run by David Tepper, received antitrust clearance from the Federal Trade Commission to potentially increase its stake in the Botox-maker. This means that Appaloosa now has more flexibility to push for further changes at Allergan. It remains to be seen if that happens, but if so, it could mean more changes are ahead for the drugmaker.
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.
Headache is a universal experience. At present, there are more than 100 different types of headache and one of the most recurring ones is migraine, which affects approximately 10-12% of the population, being three times more common in women than in men. When migraine becomes chronic -occurring more than 15 days a month-, it can disrupt patients' daily life in a great degree.
Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).
In 1998, David E.I. Pyott became CEO of Allergan. He was enthusiastic about Botox's wrinkle-reducing potential, he says, and pushed the company to conduct a series of studies on the matter. In 2002, Botox earned FDA approval for so-called frown lines--wrinkles between eyebrows--marking the first time a pharmaceutical drug was given the green light for a strictly cosmetic purpose. In 2001, the year before Botox was approved for wrinkles, it generated about $310 million in sales. By 2013, the year it was approved for overactive bladder, Allergan reported nearly $2 billion in revenue from Botox.
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Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscle for the treatment of cervical dystonia have been reported to be at greater risk for dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Injections into the levator scapulae may be associated wit h an increased risk of upper respiratory infection and dysphagia.
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.
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The potency Units of BOTOX 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 DESCRIPTION].
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.'”
"I had 25 units of Botox done by Dr. Goldberg on my forehead and frown lines. Few days later I could see the result with which I was very happy! [...] I have done Botox few times before with other specialists, after which my face would resemble a doll [...] However, after procedure with Dr. Goldberg, I am still able to lift my eyebrows and frown without forming any wrinkles." – from Dinara D.'s review of Alexander Golberg Physician PC in New York.
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.
"A migraines is an inherited neurological condition that features headaches as the most common symptom," says Robbins. "Headaches are not the only symptoms people can have. They can have sensitivity to the environment around them like light and sound. They can have nausea, which can lead to vomiting. They can have blurred vision. In a minority, but sizable number of people, it can progress to what we call chronic migraines."
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.
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.
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
If you have eyelid drooping after a Botox procedure, it is a good idea to let the cosmetic surgeon know because there is a medicine available to help this condition. Any other difficulties, such as difficulty breathing or rashes, should be reported to the surgeon immediately. Bruises are generally gone within one to two weeks, there are other medications available for the treatment of these, such as vitamin K topical treatments (Dr. Holmquist Healthcare CytoActive Post-Procedural Bruise Relief, Revision Skincare Vitamin K Serum, Clinicians Complex Bruise Cream, Glymed Plus Arnica+ Healing Cream).
William J. Binder reported in 2000 that patients who had cosmetic injections around the face reported relief from chronic headache. This was initially thought to be an indirect effect of reduced muscle tension, but it is now known that the toxin inhibits release of peripheral nociceptive neurotransmitters, suppressing the central pain processing systems responsible for migraine headache.
Botox injections use onaboutlinumtoxin A, also known as the botulinum toxin, injected in small amounts to certain points in the head to treat migraine headaches, tension headaches, and chronic daily headaches. This treatment has been shown to be most effective for headaches that are located in the forehead and neck. Botox has also been used to treat the following conditions:
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).