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, generalized 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.
The Company is developing a number of products, some of which utilize drug delivery systems, through a combination of internal and collaborative programs, such as Esmya, Sarecycline, Ubrogepant, Abicipar, Bimatoprost SR, Relamorelin, Rapastinel, Cenicriviroc and Atogepant. The Company's portfolio of branded pharmaceutical products within the US Specialized Therapeutics, US General Medicine and International segments includes Alphagan/Combigan, which is used for the treatment of selective alpha2 agonist; Armour Thyroid, which is used for the treatment of Underactive thyroid; Asacol/Delzicol, which is used for the treatment of ulcerative colitis; Botox, which is used for the treatment of acetylcholine release inhibitor; Bystolic, which is used for the treatment of hypertension; Carafate/Sulcrate, which is used for the treatment of ulcerative colitis, and Dalvance, which is used for the treatment of acute bacterial skin infections. It also offers Estrace Cream, which is used for the treatment of hormone therapy; Linzess/Constella, which is used for the treatment of irritable bowel syndrome; Lo Loestrin which is an oral contraceptive; Lumigan/Ganfort, which is used for the treatment of prostaglandin analogue; Minastrin 24, which is an oral contraceptive; Namenda IR, Namenda XR and Namzaric, which are used for the treatment of Dementia; Restasis, which is used for the treatment of topical immunomodulator; Saphris, which is used for the treatment of schizophrenia, bipolar mania; Teflaro, which is used for the treatment of acute bacterial skin infections, community-acquired bacterial pneumonia; Viberzi, which is used for the treatment of irritable bowel syndrome; Viibryd/Fetzima, which is used for the treatment of depressive disorders, and Zenpep, which is used for the treatment of exocrine pancreatic insufficiency. The Company also offers CoolSculpting, which is a controlled-cooling fat reducing system.
The median duration of response in Study OAB-1 and OAB-2, based on patient qualification for re-treatment, was 19-24 weeks for the BOTOX 100 Unit dose group compared to 13 weeks for placebo. To qualify for re -treatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least 2 urinary incontinence episodes over 3 days.
According to the PREEMPT paradigm, one injection of 5 units of onabotulinumtoxinA into four sites (total 20 units) into the frontalis muscle is done. The injection points are located by visually drawing a line up from the medial edge of the supraorbital rim. Patients will be injected into the muscle in the upper third of the forehead at least 1 to 2 fingerbreadths above the corrugator injection site. The lateral muscle injection areas are parallel and approximately 1 fingerbreadth lateral to the medial injection site, which is roughly in line with either the midpupillary line or the lateral edge of the cornea, which is the limbus line. In cases in which I am worried about ptosis, I inject the frontalis close to the hairline. In order to reduce the risk of these unwanted effects, injections should be administered in the upper third of the forehead only. The needle should be inserted at a 45° angle superiorly. Because the frontalis is an elevator muscle, weakening can cause brow ptosis or exacerbate preexisting brow ptosis.
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Chronic migraines are what were formerly known as “transformed” migraines. These are near daily headaches, sometimes with migraine features but otherwise with frequent features of tension headaches. This may sound trivial but the treatment for tension headaches, typically with analgesics, would only make this syndrome worse. We learned that treating these with migraine preventive medications proved mostly effective. The current International Classification of Headache Disorders defines chronic migraine as a recurrent headache that has been ongoing for the past 3 months, occurs on at least 15 days per month, lasts at least 4 hours per day, and has 8 or more days per month when the headache has features of a migraine or responds to a typical migraine medication.
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibo dy) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to onabotulinumtoxinA in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
It is not always clear what is causing chronic migraines. BOTOX is a viable option for treating migraines, and it may be the most effective treatment for you. Migraines lead to extreme pain that impacts every aspect of life, from personal to professional. Migraines are debilitating and for some who suffer from the condition, bedrest is the only option. A BOTOX treatment for migraines is a simple procedure but could vastly improve your quality of life.
Marrying ophthalmology to dermatology, Jean and Alistair Carruthers observed that blepharospasm patients who received injections around the eyes and upper face also enjoyed diminished facial glabellar lines (“frown lines” between the eyebrows), thereby initiating the highly-popular cosmetic use of the toxin. Brin, and a group at Columbia University under Monte Keen made similar reports. In 2002, following clinical trials, the FDA approved Botox Cosmetic, botulinum A toxin to temporarily improve the appearance of moderate-to-severe glabellar lines. The FDA approved a fully in vitro assay for use in the stability and potency testing of Botox in response to increasing public concern that LD50 testing was required for each batch sold in the market.
As you noted in your question, the effects of Botox don't last forever. For some patients the short term effects of Botox are a ‘good thing,’ as it means that trying Botox is a relatively low risk/low commitment procedure. If you don't like your Botox results, there's not much to worry about: They will fade on their own in a few months. Generally speaking, the results last between three to five months -- but the duration of the Botox effect depends on the individual and on how many Botox units were used.
Allergan has a deep commitment to the health and well-being of patients who use our products and the global communities where we operate. We are focused on access to our medicines, as well as environmental, health and sustainability initiatives. In 2016, Allergan introduced Our Social Contract with Patients, focused on four areas – Invest & Innovate, Access & Pricing, Quality & Safety, and Education -- where Allergan is committed to doing what is right for patients and society
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
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.
There were 214 subjects evaluated for the open label period, of which 170 progressed into the randomized, blinded treatment p eriod (88 in the BOTOX group, 82 in the placebo group). Patient evaluations continued for at least 10 weeks post-injection. The primary outcome for the study was a dual endpoint, requiring evidence of both a change in the Cervical Dystonia Severity Scale (CDSS) and an increase in the percentage of patients showing any improvement on the Physician Global Assessment Scale at 6 weeks after the injection session. The CDSS quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS a llots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54). The Physician Global Assessment Scale is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from 4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. Pain is also an important symptom of cervical dystonia and was evaluated by separate assessments of pain frequency and severity on scales of 0 (no pain) to 4 (constant in frequency or extremely severe in intensity). Study results on the primary endpoints and the pain-related secondary endpoints are shown in Table 35.
Preventative Botox has been getting lots of buzz. “It can potentially have a preventive effect on dynamic wrinkles, which are caused by underlying muscle movement,” Shah explains. “That being said, muscle movement is only one factor that contributes to the development of wrinkles, so Botox may not be completely preventive.” (Some other wrinkle causes: sun exposure, smoking, and diet.)
In the first study, researchers examined a sample of healthy subjects and patients with a diagnosis of migraine -any frequency-, and analysed the presence of trigger points and their location, many of the explorations resulting in a migraine crisis. The most interesting findings of this study were: 95% of migraine sufferers have trigger points, while only 25% of healty subjects have them. The most common locations of trigger points are the anterior temporal and the suboccipital region, both billateral, of the head. Furthermore, researchers found a positive correlation among the number of trigger points in a patient, the number of monthly crises and the duration in years of the condition.
BOTOX may be an effective treatment for those who suffer from chronic migraines. Many patients have struggled to find a treatment that truly provides relief from this debilitating condition. While there are migraine medications and a host of natural remedies, for many people, none of these methods bring real relief. BOTOX may be the option that brings the relief from pain that patients have been seeking for so long.
“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.”
Each patient has their own goals for treatment of muscle spasticity made in our clinic. These goals can include decreasing pain from muscle spasms. This can be done by reducing both how often and how intense the spasms are. It can also be done by increasing the range of motion of joints to allow improved function. Improvement of range of motion can help to:
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!
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.
Sunburn alert: The AHA/BHA Exfoliating Cleanser and AHA/BHA Cream in the Lytera® 2.0 Advanced Pigment Correcting System contain an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using these products (or this system) and for a week following.
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.
"There is a difference in pricing based on the duration of the results," says L.A.-based injection specialist Lisa Goodman. (FYI: She's incredible, and I emphatically recommend seeing her if you're in L.A. or Dara Liotta, MD, if you're in NYC.) "The longer-lasting formulas cost more upfront. Shorter-term fillers can last from six to 11 months based on the patient's rate of aging (i.e., smoking, drinking, sun exposure, genetics), while the longer-term fillers last about one to two years."
Vials of BOTOX have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. In order to see the hologram, rotate the vial back and forth between your fin gers under a desk lamp or fluorescent light source. (Note: the holographic film on the label is absent in the date/lot area.) If you do not see the lines of rainbow color or the name “Allergan”, do not use the product and contact Allergan for additional information at 1-800-890-4345 from 7:00 AM to 3:00 PM Pacific Time.
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.
Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
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).
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.
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.
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).
Three percent of patients experienced eyelid drooping in the frown lines studies, one percent of patients experienced eyelid swelling in the crow's feet studies, and one percent of patients experienced brow drooping in the forehead lines studies. Other possible side effects include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems: double vision, blurred vision, decreased eyesight and dry eyes; and allergic reactions. These are not all of the possible serious side effects of BOTOX® Cosmetic. Please see the Important Safety Information including Boxed Warning and Medication Guide and talk to your specialist.
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.