Two double-blind, placebo-controlled, randomized, multi-center, 24-week clinical studies were conducted in patients with OAB with symptoms of urge urinary incontinence, urgency, and frequency (Studies OAB -1 and OAB-2). Patients needed to have at least 3 urinary urgency incontinence episodes and at least 24 micturitions in 3 days to enter the studies. A total of 1105 patients, whose symptoms had not been adequately managed with anticholinergic therapy (inadequate response or intolerable side effects), were randomized to receive either 100 Units of BOTOX (n=557), or placebo (n=548). Patients received 20 injections of study drug (5 units of BOTOX or placebo) spaced approximately 1 cm apart into the detrusor muscle.
The following adverse reactions have been identified during post-approval use of BOTOX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: abdominal pain; alopecia, including madarosis; anorexia; brachial plexopathy; denervation/muscle atrophy; diarrhea; hyperhidrosis; hypoacusis; hypoaesthesia; malaise; paresthesia; peripheral neuropathy; radiculopathy; erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption; strabismus; tinnitus; and visual disturbances.
Tell your doctor if you have 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.
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Program Terms, Conditions, and Eligibility Criteria: 1. This offer is good for use only with a valid prescription for BOTOX® (onabotulinumtoxinA). 2. Based on insurance coverage, Chronic Migraine patients can receive up to $700 off per treatment for up to 5 treatments in 2018. All treatments must be received during 2018. Maximum savings limit of $3500 per year for people with Chronic Migraine applies; patient out-of-pocket expense may vary. 3. This offer is not valid for use by patients enrolled in Medicare, Medicaid, or other federal or state programs (including any state pharmaceutical assistance programs), or private indemnity or HMO insurance plans that reimburse you for the entire cost of your prescription drugs. Patients may not use this offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees. This offer is not valid for cash-paying patients. 4. This offer is valid for up to 5 treatments per year. Offer applies only to treatment received before the program expires on 12/31/18. 5. Offer is valid only for BOTOX® and BOTOX® treatment-related costs not covered by insurance. 6. A BOTOX® Savings Program check will be provided upon approval of a claim. The claim must be submitted with treatment details from an Explanation of Benefits (EOB) or a Specialty Pharmacy Provider (SPP) receipt. (If the BOTOX® prescription was filled by a Specialty Pharmacy Provider, both EOB and SPP details must be provided.) All claims must be submitted within 90 days of the date of EOB receipt. You may be required to provide a copy of your EOB or SPP receipt for your claim to be approved. 7. A BOTOX® Savings Program check may be sent either directly to you or to your selected healthcare provider who provided treatment. For payment to be made directly to your healthcare provider, you must authorize an assignment of benefit during each claim submission. You are not obligated to assign your BOTOX® Savings Program benefit to your healthcare provider to participate in the program. 8. Allergan reserves the right to rescind, revoke, or amend this offer without notice. 9. Offer good only in the USA, including Puerto Rico, at participating retail locations. 10. Void where prohibited by law, taxed, or restricted. 11. This offer is not health insurance.12. By participating in the BOTOX® Savings Program, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.
Pharmaceutical companies are not without blame. One reason why insurers impose step therapy is high drug prices. Botox, which is made from the toxin of certain bacteria, is much more expensive than other migraine treatments like beta blockers, which are available as generics. Botox costs about $4,800 a year, but with injection fees, treatment can cost up to $10,000 a year. “They could lower the price,” says Loder. “Their goal is to maximize return on investment for their stockholders. That’s not the same thing as maximizing benefits for patients, unfortunately.”

Baby Botox can also be used as an upkeep strategy. "I really think of it as small maintenance doses of Botox over time instead of standard doses given at three- to six-month intervals," says Smith. "The other term that describes this well is 'tweakment' — subtle changes done over a longer period of time using lower doses of product at each treatment."


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.
In a double-blind study of 123 adults with regular, chronic migraine, the adults receiving botulinum toxin type A experienced fewer migraine attacks each month. In addition, attacks they did experience were less intense, of shorter duration, and required less treatment than adults who did not receive Botox injections for migraine. These injections were also well-tolerated in adults experiencing migraine with and without aura.
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).
Some doctors, however, say their experience with their own patients indicates Botox — which was approved by the FDA in 2010 to treat migraines — is quite effective for this purpose. Lawrence Newman, MD, a neurologist and director of the headache division at NYU Langone Medical Center in New York City, says many of his patients have experienced a significant decline in the number of headaches per month after receiving Botox. In many cases, he says, it has cut down that number by 50% and frequently more than that.
Some critics say Botox makes you lose all the personality from your face, leaving you with a significantly less range of motion when you laugh, or get angry or upset. While it’s true that your movement will be restricted, a moderate amount of Botox will still allow you to react and communicate in a lively way. “Botox relaxes the wrinkle-forming facial muscles at the sight of injection, such as crow’s feet, glabella (the ‘furrows’ in between the brows), and frontalis (forehead lines),” Dr. Waibel says. “Botox does not affect other facial muscles that are used for overall facial expressions.”

Some critics say Botox makes you lose all the personality from your face, leaving you with a significantly less range of motion when you laugh, or get angry or upset. While it’s true that your movement will be restricted, a moderate amount of Botox will still allow you to react and communicate in a lively way. “Botox relaxes the wrinkle-forming facial muscles at the sight of injection, such as crow’s feet, glabella (the ‘furrows’ in between the brows), and frontalis (forehead lines),” Dr. Waibel says. “Botox does not affect other facial muscles that are used for overall facial expressions.”
Two preparations of botulinum antitoxins are available for treatment of botulism. Trivalent (A,B,E) botulinum antitoxin is derived from equine sources using whole antibodies. The second antitoxin is Heptavalent (A,B,C,D,E,F,G) botulinum antitoxin, which is derived from equine antibodies which have been altered to make them less immunogenic. This antitoxin is effective against all known strains of botulism.
A double-blind, placebo-controlled study enrolled patients who had extended histories of receiving and tolerating BOTOX injections, with prior individualized adjustment of dose. The mean BOTOX dose administered to patients in this study was 236 Units (25th to 75th percentile range of 198 Units to 300 Units). The BOTOX dose was divided among the affected muscles [see Clinical Studies].
Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The initial dose for a patie nt without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response. Limiting the total dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia [see WARNINGS AND PRECAUTIONS].
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.
Some industry insiders say it's not unusual, if still legally murky, for drug-company representatives and doctors to share information with one another about the different ways an approved drug may be used. If a doctor notices that, say, a treatment for crossed eyes also "takes the lines out," he may mention it to the representative from whom he buys the drugs. That rep may share that with another of his clients, and so on.
Botox, or onabotulinumtoxinA, is used for three main purposes: muscle spasm control, severe underarm sweating and cosmetic improvement. In this article we concentrate on the third use, achieved with the product called Botox Cosmetic, which contains botulinum toxin type A (the active ingredient), human albumin (a protein found in human blood plasma) and sodium chloride.
Lastly, a Botox treatment does not offer permanent results. Botox is most effective when treatments are carried out at regular intervals before the results fully wear off. On average, the results last for three to four months,  although Botox metabolizes at different rates in different individuals. The first ever Botox treatment you receive may not last as long as subsequent treatments, plus you may require touch-ups two weeks after the procedure as your injector determines the right dosage for you. Over time, however, many patients notice that they can wait longer intervals between treatments as their treated facial muscles weaken.
“I don’t think it is physically addictive,” says Dr. Matarasso. “But, I have to be very frank with you, when I get a new patient I tell them (and I say this tongue-in-cheek) this product is truly addictive. I make jokes with my patients that we need a 12-step program for it, because when it’s done correctly, it’s a very simple office procedure, with impressive cosmetic results.”
Patients with compromised respiratory status treated with BOTOX for spasticity should be monitored closely. In a double-blind, placebo-controlled, parallel group study in patients treated for upper limb spasticity with stable reduced pulmonary function (defined as FEV1 40-80% of predicted value and FEV1/FVC ≤0.75), the event rate in change of Forced Vital Capacity (FVC) ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 5).
A migraine requires only two of the following headache features: a unilateral distribution (one-sided), pulsatile quality (throbbing), moderate or severe pain (more than 5 out of 10), and aggravation by physical activity (such as bending over). In addition, to diagnose migraine, only one of the following is required: nausea or vomiting or sensitivity to light and noise.

Botox costs can vary anywhere from $200 to $400 or more depending on the physician, location, units purchased, desired profit margin, ongoing promotions, etc. Many doctor's offices price Botox based on cost per unit, but others price Botox injections based on the area of the injection. Whether Botox is charged by the unit or by the area might not matter that much if the Botox treatment is effective, but if you want to know exactly how much you are paying for your treatment, you need to know the number of units of Botox per treatment and the cost per unit. (An honest practice will not hesitate to give you this information if you ask.)
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."
The overall cost of  the injection is charged either at a flat rate or per unit. In terms of per unit, the overall cost of the treatment will depend on the total volume or a total number of units used in the procedure. But service charged at a flat rate depends on the area to be treated. The most expensive area is around the underarm for treating hyperhidrosis.
Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
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.

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!
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).
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[88] 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.[89]
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.
When most people see the results of Botox, they are extremely pleased. Botox’s ability to iron out wrinkles is pretty impressive. The fine lines and wrinkles that were all you could see in the mirror appear much less severe and the overall appearance is refreshed and more relaxed and rejuvenated. Botox results typically last up to six months. Botox also acts as a preventative measure for wrinkles, as it prevents repetitive folding of the skin that come from the frequency of making expressions. By injecting Botox before wrinkles even form, you’re setting the stage for a younger look for years to come.
Reduced blinking from BOTOX injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other me ans.
In the third study, 25 patients with chronic migraine were injected with 12.5 doses of botox into each trigger point twice, during a period of 3 months. Frequency (main variable), intensity and scales of migraine crises were recorded one month before and one month after the treatment to compare the changes experienced. In addition, side effects were also recorded during the experiment, and they were found to be mild and temporary.
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.

Firstly, that is one of the most popular combination of areas for Botox treatment in my office. Like others on this panel, I happen to think the fairest method for charging for Botox is by the unit. Botox can only be purchased through Allergan here in the United States and comes in a 100 unit bottle typically. The only common denominator between offices is how many units of Botox are you... READ MORE

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.”
At Allergan, you will have the opportunity to thrive in a fast-paced, strategic environment where bold thinking isn’t just welcomed, it’s encouraged. Allergan is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Our world-class team develops, manufactures and commercializes innovative branded pharmaceuticals, devices, biologic and tissue products for patients around the world.

Food-borne botulism results, indirectly, from ingestion of food contaminated with Clostridium spores, where exposure to an anaerobic environment allows the spores to germinate, after which the bacteria can multiply and produce toxin.[citation needed] Critically, it is ingestion of toxin rather than spores or vegetative bacteria that causes botulism.[citation needed] Botulism is nevertheless known to be transmitted through canned foods not cooked correctly before canning or after can opening, and so is preventable.[citation needed] Infant botulism cases arise chiefly as a result of environmental exposure and are therefore more difficult to prevent.[citation needed] Infant botulism arising from consumption of honey can be prevented by eliminating honey from diets of children less than 12 months old.[71]


In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
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