Contrary to popular belief, the bacteria that causes botulism, clostridium botulinum, is not part of the treatment, nor are six of the seven neurotoxins it secretes. The only substance used in Botox injections, botulinum toxin A, is carefully extracted, purified, and standardized into FDA-approved doses. Plus, the dosage is so small, it can't get beyond the muscle tissue it's injected into, meaning there's little if any chance for Botox to reach the bloodstream.
Contrary to popular belief, the bacteria that causes botulism, clostridium botulinum, is not part of the treatment, nor are six of the seven neurotoxins it secretes. The only substance used in Botox injections, botulinum toxin A, is carefully extracted, purified, and standardized into FDA-approved doses. Plus, the dosage is so small, it can't get beyond the muscle tissue it's injected into, meaning there's little if any chance for Botox to reach the bloodstream.
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).
In 2005, the national average cost of a BOTOX® injection was just over $375. However, the cost of BOTOX® treatment varies from area to area. In 2005, the northeastern United States had the highest BOTOX® average cost, at just over $500, while the western states had the lowest average, at under $370. It is important to keep in mind that these statistics may be somewhat misleading, as the cost of BOTOX® injections in Los Angeles will almost certainly be higher than BOTOX® treatment price in say, a rural area of Pennsylvania.
Not to be evasive, but the cost varies between physicians depending on how much Allergan product they purchase in a year. In general, it will probably be from $500 to $550 for a 100 unit vial. The equipment required to properly inject botox is not cheap, since it takes specialized syringes and needles that aid in precision and comfort. And properly trained staff and appropriately-medical... READ MORE
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.
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.
As with with plastic surgery or any other cosmetic procedure, what you are paying for is an injector who has experience and a proven track record of beautiful results. If you're looking for a precise estimate of what it will cost to achieve your Botox goals, I encourage you to meet with a board-certified plastic surgeon or dermatologist for an initial consultation.

Other treatment areas that have been proven to be useful include the scalp (for migraine headaches), neck, facial and peripheral muscles (for spasms), arm pits (to inhibit sweating), the bladder and numerous other areas. The way that Botox and Dysport work is that they temporarily inhibit muscle contraction beneath the skin. When underlying muscles are relaxed the overlying folds and wrinkles are smoothed out. These injections work only by weakening underlying muscle contraction are not facial fillers like Restylane or Juvederm. Fillers and Botox or Dysport injections are not interchangeable. These injections work only by weakening underlying muscle contraction are not facial fillers like Restylane or Juvederm. Fillers are not interchangeable with Botox or Dysport injections. Fillers replace or “fill-in” lost facial volume whereas Botox or Dysport only inhibit muscle contraction.Both treatments are in fact complimentary aesthetic injections that will relax wrinkles and folds and help you regain your youthful appearance and enhance your face.

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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.
Botox injections like other goods and services in New York City are typically more expensive then in the suburbs where the rent and salaries are also less expensive. So it is true that in general Botox cost more in NYC. In one vial of Botox there is 100 units of medicine and each unit costs on average $20. Most patients require between 20 to 60 units.That translates into an average between $400 and $1200.

Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than nondiabetics. In clinical trials, 12.3% of patients (10/81) with diabetes developed urinary retention following treatment with BOTOX® 100 Units vs 0% of patients (0/69) treated with placebo. In patients without diabetes, 6.3% of patients (33/526) developed urinary retention following treatment with BOTOX® 100 Units vs 0.6% of patients (3/516) treated with placebo.
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.
It's also not approved by the U.S. Food and Drug Administration (FDA) for depression, not that that stops doctors from prescribing it that way. Such off-label use of Botox, like that of any FDA-approved drug, is legal in the U.S. That's because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit, regardless of whether it's been proved to work for that condition.
When the deal with Teva closed in August 2016, it left Allergan with $40 billion to spend. Some of that went to repurchase shares, while some went to a series of acquisitions that totaled about $6.5 billion. One of the bigger deals was for a company developing treatments for NASH, a liver condition that Saunders said would become "one of the next epidemic-level chronic diseases we face as a society."
Beware of Botox injections at a "Botox party" at someone's house. You need to be in a medical setting, where any side effects can be treated immediately. You may not see the final effects of the injections during the party anyway, as they usually take a few days. A Botox party isn't such a bad idea if it's held by a doctor in a medical setting, but even then there's a risk of the doctor's attention being divided between you and the other attendees.
Other adverse reactions that occurred more frequently in the BOTOX group compared to the placebo group at a frequency less th an 1% and potentially BOTOX related include: vertigo, dry eye, eyelid edema, dysphagia, eye infection, and jaw pain. Severe worsening of migraine requiring hospitalization occurred in approximately 1% of BOTOX treated patients in Study 1 and Study 2, usually within the first week after treatment, compared to 0.3% of placebo-treated patients.
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.
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.[52] Brin, and a group at Columbia University under Monte Keen made similar reports.[53] In 2002, following clinical trials, the FDA approved Botox Cosmetic, botulinum A toxin to temporarily improve the appearance of moderate-to-severe glabellar lines.[54] 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.[55][56]

The safe and effective use of BOTOX depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. An understanding of standard electromyographic techniques is also required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia. Physicians administering BOTOX must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease, especially when injecting near the lungs.
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspira tion pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.
"As we get older, we lose volume in our face and hyaluronic acid filler can be used as a replacement,” explains Wexler. "For younger women, injections can be used to treat areas with acne scarring or hollowness under the eyes." During your ‘20s, when the face is at its fullest and healthiest, it has been argued that a shadowy gaze can even be quite charming. But in other cases, hereditary dark circles can result in a persistently tired look, which is where a few drops of filler under the eyes may be useful. As top dermatologist David Colbert, M.D. is quick to note, however, too much Botox and filler distorts the face and as a result will make you appear older. “When the line is crossed everyone starts looking like they are related," he also cautions of a uniform cookie-cutter appearance that lacks character or individuality. Or worse. “It’s a snowball effect of people liking something, coming back too soon [for even more], and then it gets too heavy,” adds Wexler.

The most common severe adverse reaction associated with the use of BOTOX injection in patients with cervical dystonia is dysp hagia with about 20% of these cases also reporting dyspnea [see WARNINGS AND PRECAUTIONS]. Most dysphagia is reported as mild or moderate in severity. However, it may be associated with more severe signs and symptoms [see WARNINGS AND PRECAUTIONS].

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].

Remember that the skill of the injector is extremely important when considering Botox injections. Because Botox can have some very obvious and embarrassing side effects like drooping eyelids, blurry vision, and excessive bruising around the injection site, it's important to consult with an experienced injector. Unlike dermal fillers which can be melted away with a follow-up injection of hyaluronidase, there's not much you can do about a bad Botox experience other than wait it out.
In recent years, a number of high-profile lawsuits have been brought against Allergan in which plaintiffs claimed that off-label uses--for ailments including a child's cerebral-palsy symptoms, for instance, or an adult's hand tremors--resulted in lasting deleterious side effects. Still, the drug's acceptance in a growing number of doctors' offices worldwide, and its revenue growth, show no signs of slowing.

It was peculiar advice coming from a shrink, but not without precedent. In 2014, Rosenthal, a clinical professor of psychiatry at Georgetown University School of Medicine, and Dr. Eric Finzi, an assistant professor of psychiatry at George Washington School of Medicine, published a study showing that when people with major depression got Botox, they reported fewer symptoms six weeks later than people who had been given placebo injections. "I'm always on the lookout for things that are unusual and interesting for depression," says Rosenthal, who is widely considered an expert on the condition. "I've found Botox to be helpful, but it's still not mainstream."
Botox was introduced to the world in the late 1980s by ophthalmologists, who began using it to treat optic muscle disorders. It was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines) in 2002, and its popularity has soared ever since. Botox is consistently one of the top five nonsurgical cosmetic procedures performed each year.
It's also not approved by the U.S. Food and Drug Administration (FDA) for depression, not that that stops doctors from prescribing it that way. Such off-label use of Botox, like that of any FDA-approved drug, is legal in the U.S. That's because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit, regardless of whether it's been proved to work for that condition.
As the only Facial Plastic Surgeon in North Texas to have Diamond status with Allergan, we have found that in today's economic environment, patients want value as well as quality. Understand that when you go to a non-physician med-spa for injectible treatments, there are more hands in the "cookie jar" diluting the price for your treatment. For example, the med-spa that is owned by a non-physician, with a nurse injector, is the hardest model to stay competitive in today's world. In that scenario, the patient is paying for the cost of the Botox; PLUS the cost of the nurse to inject the product; PLUS the fee for the medical director to sign off on the nurse doing the injections; AND the profit for the medspa. By going to a physician, the patient can cut out 2 of the middle-people. The chances of getting more product for the same price is greater by going to a doctor's office for your treatment.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
How Was the Botox Mixed? A 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 can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
"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."
As compared to standard-size injections, Baby Botox lowers the risk of your features appearing to be frozen. Take the forehead, for example: "The risk is that you weaken your frontalis muscle, which causes your eyebrows to drop," Darren Smith, a board-certified plastic surgeon in New York City, tells Allure. "If you're getting micro doses of Botox, that's a lot less likely to happen."
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
Dr. Engelman says preventative is legit. “Most certainly! I do micro-injections on patients who are just starting to show the finest expression lines in order to prevent them from ever making the wrinkle." NYC-based board-certified plastic surgeon Norman Rowe, MD, is also a fan. "While Botox has a fundamental use in treating wrinkles that are already formed, it has a role in the prophylactic, or prevention, of wrinkles. So, don't think that you don't need Botox because you don't have wrinkles. If you want to keep that smooth skin, start with Botox before they form."

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.

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]


Botox can be bought by essentially any person with a DEA certificate. Allergan sells it in 50 and 100 unit vials. They are shipped overnight delivery on dry ice to keep the toxin effective it should be opened, reconstituted and used the same day ideally. The Botox will work best this way. Price points will change by who the injector is and what their motives are. Botox can be reconstituted so that you getting a very dilute amount of product. So a by the area approach may really only give you a small amount of product. Or you could be getting old Botox that is a week old and will not last for very long.

Allergan says Botox is well established as a drug and that the benefits and risks of toxins are well understood. "With more than 25 years of real-world clinical experience ... approximately 3,200 articles in scientific and medical journals, marketing authorizations in more than 90 markets and many different indications, Botox and Botox Cosmetic are [among] the most widely researched medicines in the world," an Allergan rep wrote in an emailed statement.
The safety and effectiveness for the treatment of anatomic regions other than the mid-face with JUVÉDERM VOLUMA® XC; facial wrinkles and folds with JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE™ XC; and the lips and perioral area with JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC have not been established in controlled clinical studies
The 3rd Annual Migraine Moment Film Contest received a record-breaking number of film submissions this year. Each film delivered a unique message on living with migraine and how people cope with the symptoms that accompany this debilitating disease. At the 60th Annual Scientific Meeting in San Francisco earlier this year, Maria Galli was announced as the contest’s winner. Her powerful film, Invisible Hero, spoke to her strength and superhero-like qualities in fighting a disease that oftentimes makes her feel isolated and alone. In a recent Facebook Live hosted by the American Foundation, Maria Galli spoke with Dr. Bert Vargas, a Neurologist at UT Southwestern, about her experience living with chronic migraine and her outstanding work. [embed]https://www.facebook.com/americanmigrainefoundation/videos/1616373701807260/[/embed]

In rare cases, Botox toxin can spread to areas beyond the injection site. If this happens, you may experience muscle weakness, vision changes, difficulty swallowing, and drooping eyelids. To reduce your risk of serious side effects and complications, always make sure Botox is prescribed and administered by a trained healthcare professional who has experience in using Botox.


It’s been a little over three weeks. The neurologist said that after two weeks, my migraines and headaches should be substantially reduced. I haven’t spoken about it much even to people close to me because I didn’t want to jinx it, but right around the two-week mark, my headaches faded. I did have a migraine the day after the injections, followed by a lingering headache for about a week, but my neurologist didn’t think it was caused by the Botox. I know my body and have a feeling it was, especially because the introduction or removal of medication can exacerbate lupus symptoms and flares, so I was put on a prednisone taper just to be safe.
I’ve had migraine since I was 5 and have learned a lot over the years about how to manage it. I’m aware of the foods that trigger my migraine attacks, and I try to eat consistently and drink a lot of water. My children and I eat as healthy as possible throughout the day to keep energy up, knowing skipped meals are a trigger for both tantrums and migraine attacks. Staying on a schedule allows my body to stay stable and helps me identify triggers. The same goes for my children. Maintaining their energy and providing them with good food and water prevents them from getting “hangry” later. We all want to avoid a food meltdown. I know that I am triggered by weather, hormones, stress, diet, hydration, light, sound, heat, sleep and more. I try to be prepared for as many of these situations as I can, but some are easier to avoid than others. If you’re unaware of your triggers, keep a log. There are migraine apps that can help you track your symptoms and identify what’s causing your attacks. Finding patterns in how you react may help with identifying effective medications or alternative treatments.
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.
Safety and effectiveness of BOTOX have not been established for the treatment of other upper or lower limb muscle groups. Safety and effectiveness of BOTOX have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX is not intended to substitute for usual standard of care rehabilitation regimens.
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Study 4 included 170 patients (87 BOTOX and 83 placebo) with upper limb spasticity who were at least 6 months post-stroke. In Study 4, patients received 20 Units of BOTOX into the adductor pollicis and flexor pollicis longus (total BOTOX dose =40 Units in thumb muscles) or placebo (see Table 30). Study 5 included 109 patients with upper limb spasticity who were at least 6 months post-stroke. In Study 5, patients received 15 Units (low dose) or 20 Units (high dose) of BOTOX into the adductor pollicis and flexor pollicis longus under EMG guidance (total BOTOX low dose =30 Units, total BOTOX high dose =40 Units), or placebo (see Table 30). The duration of follow-up in Study 4 and Study 5 was 12 weeks.
Galli’s winning film presents herself, and people with migraine, as superheroes, living with a secret identity: migraine. “Other than me laying down on my couch, and knowing what's going on inside my body, nobody sees what's happening,” she says. “It's all happening inside. It's like that same struggle that superheroes have.” The migraine symptoms are superpowers, albeit ones that you don’t want. When her migraine attacks first began, Galli recalls an increased sensitivity to sound, odors, light and “all these things that feel not normal.” Many people with migraine are fighting the disease on their own, because their peers can’t relate to what their feeling on a daily basis. “It's time that we create better awareness and we tell the world that no, we don't need to be alone,” she says. “We don't need to fight alone and hide in the dark.” The film, she hopes, will add to the conversation and bring this disease out of the shadows. For the more than 37 million Americans living with migraine, Galli says: “You’re all superheroes. I hear you, I feel you.”
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.
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
The bacterium can also be found in the intestinal tracts of mammals and fish and in the gills and organs of crabs and other shellfish. Such naturally occurring instances of Clostridium botulinum bacteria and spores are generally harmless. Problems only arise when the spores transform into vegetative cells and the cell population increases. At a certain point, the bacteria begin producing botulinum toxin, the deadly neurotoxin responsible for botulism.
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