Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Results will be evident within three to 10 days. Photographs may be taken before the procedure so that patients can check their results themselves rather than relying on their memory. It is surprising to see how many people do not recall how they looked before the procedure and are amazed at the difference when shown a picture. Prior to having the procedure done, the patient should realize that Botox does not actually erase lines but relaxes them. What this means is that deeper lines will become somewhat less deep and superficial lines will nearly disappear. This can be likened to the act of steaming a garment's wrinkles rather than ironing them.
Botox is considered as an elective procedure which means that the insurance does not cover the cost. But in case of treating medical conditions, an insurance can cover the cost of the treatment but make sure to consult your doctor regarding the coverage. Botox injections can also be used to treat conditions such as excessive perspiration (hyperhidrosis), migraine and muscle spasticity.

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.
Botulinum toxin (BTX) is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species.[1] It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis. Infection with the bacterium causes the disease botulism. The toxin is also used commercially in medicine, cosmetics and research.
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).
Results will be evident within three to 10 days. Photographs may be taken before the procedure so that patients can check their results themselves rather than relying on their memory. It is surprising to see how many people do not recall how they looked before the procedure and are amazed at the difference when shown a picture. Prior to having the procedure done, the patient should realize that Botox does not actually erase lines but relaxes them. What this means is that deeper lines will become somewhat less deep and superficial lines will nearly disappear. This can be likened to the act of steaming a garment's wrinkles rather than ironing them.
Botulinum toxin has been investigated for use in patients with blepharospasm in several studies. In an open label, historical ly controlled study, 27 patients with essential blepharospasm were injected with 2 Units of BOTOX at each of six sites on each side. Twenty-five of the 27 patients treated with botulinum toxin reported improvement within 48 hours. One patient was controlled with a higher dosage at 13 weeks post initial injection and one patient reported mild improvement but remained functionally impaired.
As anyone who’s tried Botox for Migraine (or wrinkle reduction) will tell you, your forehead feels heavier after the injections are done, where the nerve endings are in essence frozen. As in ‘Frozen Face.’  Little to no movement, depending on how many units you receive and where they are injected. In my case, my usually expressive face didn’t track with my emotions: no raised eyebrows of surprise or delight or shock.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
Prior to injection, reconstitute each vacuum-dried vial of BOTOX with only sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detr usor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX should be stored in a refrigerator (2° to 8°C).
The cosmetic effect of BTX-A on wrinkles was originally documented by a plastic surgeon from Sacramento, California, Richard Clark, and published in the journal Plastic and Reconstructive Surgery in 1989.[51] Canadian husband and wife ophthalmologist and dermatologist physicians, JD and JA Carruthers, were the first to publish a study on BTX-A for the treatment of glabellar frown lines in 1992.[52] Similar effects had reportedly been observed by a number of independent groups (Brin, and the Columbia University group under Monte Keen.[53]) After formal trials, on April 12, 2002, the FDA announced regulatory approval of botulinum toxin type A (Botox Cosmetic) to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines).[54] Subsequently, cosmetic use of botulinum toxin type A has become widespread.[78] The results of Botox Cosmetic can last up to four months and may vary with each patient.[79] The US Food and Drug Administration approved an alternative product-safety testing method in response to increasing public concern that LD50 testing was required for each batch sold in the market.[55][56]

If you experience migraine symptoms on 15 or more days each month, you have chronic migraines. Over-the-counter or prescription medications may help ease some of your symptoms, but some patients don’t respond well to pain relievers. In some cases, your doctor may prescribe preventive medicines, which are designed to reduce the frequency and severity of your symptoms. According to research published in the journal Neurology, only about one-third of patients with chronic migraines take preventive medicines.
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.

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.


“A younger face has a heart shape, and an older face is a little more bottom-heavy and square,” says Dr. Matarasso. “But if you put toxin in both sides, you are not reducing the movement of the muscle, you are thinning the muscle out a bit. You can restore a youthful look. It’s not as dramatic or quick-acting as other areas, but it can be a nice way to improve the contour of the face.”
Results will be evident within three to 10 days. Photographs may be taken before the procedure so that patients can check their results themselves rather than relying on their memory. It is surprising to see how many people do not recall how they looked before the procedure and are amazed at the difference when shown a picture. Prior to having the procedure done, the patient should realize that Botox does not actually erase lines but relaxes them. What this means is that deeper lines will become somewhat less deep and superficial lines will nearly disappear. This can be likened to the act of steaming a garment's wrinkles rather than ironing them.
Don’t be a pill. You're more likely to get a bruise at the site of the needle injection if you're taking aspirin or ibuprofen; these medications thin the blood and increase bleeding which causes the bruise. Skip the pills for two weeks in advance of your treatment. You should also tell your doctor -- before treatment -- about any supplements you're taking, even if they're "natural," because some (such as fish oil pills, gingko, or vitamin E) also thin blood. Your doctor may ask you not to use those supplements for two weeks before your treatment.
Botulinum toxin is used to treat a number of disorders characterized by overactive muscle movement, including post-stroke spasticity, post-spinal cord injury spasticity, spasms of the head and neck,[8] eyelid,[9] vagina,[10] limbs, jaw, and vocal cords.[11] Similarly, botulinum toxin is used to relax clenching of muscles, including those of the oesophagus,[12] jaw,[13] lower urinary tract and bladder,[14] or clenching of the anus which can exacerbate anal fissure.[15] It may also be used for improper eye alignment.[16] Botulinum toxin appears to be effective for refractory overactive bladder.[17]

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,[18] 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.
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women. In animal studies, administration of BOTOX during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see Data)].
A randomized, multi-center, double-blind, placebo-controlled study of the treatment of cervical dystonia was conducted. This study enrolled adult patients with cervical dystonia and a history of having received BOTOX in an open label manner with perceived good response and tolerable side effects. Patients were excluded if they had previously received surgical or other denervation tre atment for their symptoms or had a known history of neuromuscular disorder. Subjects participated in an open label enrichment period where they received their previously employed dose of BOTOX. Only patients who were again perceived as showing a response were advanced to the randomized evaluation period. The muscles in which the blinded study agent injections we re to be administered were determined on an individual patient basis.
Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. It operates through the following business segments: US Specialized Therapeutics; US General Medicine, and International. The US Specialized Therapeutics segment includes sales and expenses relating to branded products within the United States. The US General Medicine segment involves Central Nervous System; Gastrointestinal; Women's Health; Anti-Infectives; and Diversified brands. The International segment comprises of products sold outside the United States. The company was founded on in 1984 and is headquartered in Dublin, Ireland.
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A placebo-controlled, double-blind randomized post-approval 52 week study (Study NDO-3) was conducted in MS patients with urinary incontinence due to neurogenic detrusor overactivity who were not adequately managed with at least one anticholinergic agent and not catheterizing at baseline. These patients were randomized to receive either 100 Units of BOTOX (n=66) or placebo (n=78).

Last time I went in for my Botox treatment, my doctor asked me if I wanted to try Aimovig. Amgen and Novartis, the two manufacturers, were offering two free injections before I could access the drug through my health insurance. I declined. I didn’t want to start a new treatment that I’ll likely be booted from in a few months because of how expensive it is. Plus, the Botox is working great. I just wish I could have gotten it when I first went to see a migraine specialist, two and half years ago.
In a study to evaluate inadvertent peribladder administration, bladder stones were observed in 1 of 4 mal e monkeys that were injected with a total of 6.8 Units/kg divided into the prostatic urethra and proximal rectum (single administration). No bladder stones were observed in male or female monkeys following injection of up to 36 Units/kg (~12X the highest human bladder dose) directly to the bladder as either single or 4 repeat dose injections or in female rats for single injections up to 100 Units/kg (~33X the highest human bladder dose).

Dr. Starling says the FDA approval indicates that the anti-CGRP treatments are ideal for individuals with episodic migraine who have four to 14 headache days per month, and people with chronic migraine who have 15 or more headache days per month. Clinical trials are also being conducted to see if anti-CGRP antibodies are effective for the treatment of cluster headache. “The initial studies have demonstrated that it’s likely effective for cluster headache patients,” Dr. Starling says. The FDA’s approval of these medications has been incredibly meaningful for the migraine community. “The migraine community is feeling like they’re relevant—that they’re being seen, heard and taken seriously,” Dr. Starling says. “There are many people who are working hard to develop more treatment options until we can address every patient who has migraine, and eventually find a cure.”


Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

I’ve had migraines since I was 12, but in 2015 my attacks got much worse. Without migraine-specific painkillers, my migraines make me queasy and tired, forcing me to go to bed with a freezing wet towel on my head. For the last two years, I’ve tried different medications, switched birth control pills, made lifestyle changes (less stress, more swimming, no alcohol) — to little avail. My migraines would improve for a while, but then they came back, worse than ever. Then this year, I finally discovered a treatment that works — Botox.


Prior to injection, reconstitute each vacuum-dried vial of BOTOX with only sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size syringe (see Table 1, or for specific instructions for detr usor overactivity associated with a neurologic condition see Section 2.3), and slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX should be stored in a refrigerator (2° to 8°C).
"Botox is a toxin that is extracted from a certain bacteria. It's been used for a couple of hundred years in medicine. It was first used in neurological conditions rather than cosmetic ones. It was first approved to treat spasms of the face and eye muscles. Only later was it discovered coincidentally that it could world for cosmetic purposes, like wrinkles," he says.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported.

The needle should be inserted approximately 2 mm into the detrusor, and 20 injections of 0.5 mL each (total volume of 10 mL) should be spaced approximately 1 cm apart (see Figure 1). For the final injection, approximately 1 mL of sterile normal saline should be injected so that the remaining BOTOX in the needle is delivered to the bladder. After the injections are given, patients shou ld demonstrate their ability to void prior to leaving the clinic. The patient should be obser ved for at least 30 minutes post-injection and until a spontaneous void has occurred.
BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.
In many children, there are a few muscle groups that can have very active spasticity. A more focal approach to these muscles would be better than a widespread approach. In this case a doctor may advise a nerve block to interrupt the signal to the muscle that is spastic. Once the signal that is carried to the muscle by the nerve is interrupted, the spasticity will decrease.
Currently, to participate in ARMR, you must be a patient at one of the study’s enrolling medical centers. You can see a full list of the participating centers here. “The number of centers participating in the ARMR is growing rapidly,” Dr. Schwedt says. “There will be eight or nine centers by the end of this year, and ARMR will continue to grow in 2019.” Patients at any of the participating centers who are interested in ARMR can visit ARMR.org to learn more and can contact their clinician’s office to find out how to enroll. Once enrolled, participants answer online questionnaires, provide a blood sample, and maintain a daily headache diary. Visit the ARMR website for more information and to learn about how you can get involved in the study.
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.
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.

When women in their 20's first consider getting Botox, prevention is often the primary factor, since the early signs of aging—such as crow's feet, forehead wrinkles, and fine lines—are beginning to show. "Lines get deeper and deeper with age," explains Wexler. "If you start [getting Botox] early enough and it's done properly, you're not going to need [as much] in the future." For younger patients wary of the frozen look—remember, youthful faces move—Wexler likes to employ lower doses of Botox via ultra-targeted micro injections administered on specific areas of the face such as the forehead, brows, or around the eyes.

The potency Units of BOTOX (onabotulinumtoxinA) for injection 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 WARNINGS AND PRECAUTIONS and DESCRIPTION] .


That’s enough to generate buzz on the patient forums like RealSelf among those who have tried it: “My neck is killing me” wrote one user;  I’ve got “Stiffness, pain in the neck, headache and can’t look down” reported another. Like anything, results vary widely. “I have since felt nauseous and dizzy on and off every day, as well as have blurry vision.
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.
A follow-up visit is most often scheduled at around three months after injection. The team will determine if it was helpful and if the effect is wearing off. The effect on muscle spasticity by botulinum toxin is temporary and can last for up to three to five months. This also varies with the amount of toxin injected, the size of the muscle, the degree of spasticity in the muscle, and treatment such as therapy and bracing.
Risks are very minor with this procedure. The main risks consist of headache, pain, and flu-like illness. In rare cases, there may be a drooping lid or eyebrow area. It is important for the cosmetic surgeon to assess the patient's lids before injecting because the patient may not be a good candidate if he or she has an extremely droopy lid to begin with or one that is held up by constantly arching the lids. Ptosis (a severe drooping of the eyelid) can occur in up to 5% of patients but is very rare if the cosmetic surgeon does this procedure often. These complications are typically very minor occurrences and resolve with time.
During treatment, very low doses of Botox® Cosmetic are administered via a few tiny injections directly into the muscles responsible for frown lines between the brows. By blocking the release of a chemical that causes them to contract, Botox® Cosmetic enables them to relax. The effects are very localized and, when administered by an experienced injector, do not affect your ability to smile, laugh, or otherwise show expression. Botox® Cosmetic is the only product of its kind that has been approved for use in this area.
Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.
Other potential adverse events that may occur with breast implant surgery include: asymmetry, breast pain, breast/skin sensation changes, capsular calcification, delayed wound healing, hematoma, hypertrophic scarring/scarring, implant extrusion, implant malposition, implant palpability/visibility, infection, nipple complications, redness, seroma, swelling, tissue/skin necrosis, wrinkling/rippling.
In double-blind, placebo-controlled chronic migraine efficacy trials (Study 1 and Study 2), the discontinuation rate was 12% in the BOTOX treated group and 10% in the placebo-treated group. Discontinuations due to an adverse event were 4% in the BOTOX group and 1% in the placebo group. The most frequent adverse events leading to discontinuation in the BOTOX group were neck pain, headache, worsening migraine, muscular weakness and eyelid ptosis.
The FDA approval was based on a large study showing that Botox significantly reduced migraine frequency and severity, as well as headache-related disability, compared to placebo. As just one measure of its effectiveness, many of my patients report that they’ve cut their use of rescue medications in half since starting Botox – a significant benefit for people who previously had to resort to rescue medications 15 or more times every month.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes, and drooping eyebrows. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
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