Botox is a drug made from a neurotoxin produced by the bacterium Clostridium botulinum called botulinum toxin. "It's a poison secreted by the bacteria," plastic surgeon Norman Rowe, M.D., tells SELF. Botulinum toxin has proven to be a successful and valuable therapeutic protein when dosage, frequency of treatment and variety of treated clinical conditions are considered, according to Howard Sobel, M.D., a dermatologist in New York. Basically: when it's done right. When it's done wrong—like, really, really wrong—it can cause "botulism-like symptoms," according to Mayo Clinic, which may include muscle weakness, trouble breathing, speaking or swallowing, bladder control issues, and vision problems. That is "very unlikely," but a more than convincing enough reason not to go bargain hunting for Botox.
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spasticity with BOTOX® (3% at 251 Units to 360 Units total dose) compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX® (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%). In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse event in patients treated with BOTOX® (2% at 300 Units to 400 Units total dose), compared to placebo (1%).
In the United States, botulinum toxin products are manufactured by a variety of companies, for both therapeutic and cosmetic use. A U.S. supplier reported in its company materials in 2011 that it could "supply the world's requirements for 25 indications approved by Government agencies around the world" with less than one gram of raw botulinum toxin. Myobloc or Neurobloc, a botulinum toxin type B product, is produced by Solstice Neurosciences, a subsidiary of US WorldMeds. AbobotulinumtoxinA), a therapeutic formulation of the type A toxin manufactured by Galderma in the United Kingdom, is licensed for the treatment of focal dystonias and certain cosmetic uses in the U.S. and other countries.
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.
As of 2013, botulinum toxin injections are the most common cosmetic operation, with 6.3 million procedures in the United States, according to the American Society of Plastic Surgeons. Qualifications for Botox injectors vary by county, state and country. Botox cosmetic providers include dermatologists, plastic surgeons, aesthetic spa physicians, dentists, nurse practitioners, nurses and physician assistants.
Besides the three primary U.S. manufacturers, there are numerous other botulinum toxin producers. Xeomin, manufactured in Germany by Merz, is also available for both therapeutic and cosmetic use in the U.S. Lanzhou Institute of Biological Products in China manufactures a BTX-A product; as of 2014 it was the only BTX-A approved in China. BTX-A is also sold as Lantox and Prosigne on the global market. Neuronox, a BTX-A product, was introduced by Medy-Tox Inc. of South Korea in 2009;
Botox injections for migraines have been proven to reduce the intensity and duration of migraines for those who suffer. Botox was developed in the 1970s by an ophthalmologist who was looking to develop a treatment for strabismus (crossed eyes). This simple migraine treatment was discovered accidentally when people undergoing plastic surgery also experienced migraine relief. While they don’t work for everyone, Botox injections for migraines offer another way to approach treatment of migraine headaches.
Botulism is an illness caused by a neurotoxin produced by the bacterium Clostridium botulinum. There are three types of botulism: food-borne, wound, and infant. Symptoms include muscle paralysis, dry mouth, constipation, slurred speech, and blurred vision. If food-borne and wound botulism are detected early enough, they may be treated with an antitoxin. Infant botulism is treated intravenously with BabyBIG (Botulism Immune Globulin).
Some service providers offer financing options to make the procedure affordable. The Botox Cosmetic product is eligible for the Brilliant Distinctions Program that helps the members through savings, rebates, bonus points, and other perks. But there are also some providers with their own rebate program that gives a discount on the next procedure by 10% to 25%. Coupons are available in forms of discount, promo or free service for loyal customers. Also, a large volume of Botox used in the treatment, there is a possibility to avail discounted price of the Botox per unit.
Baby Botox can be used pretty much anywhere on your face, but it's best to create subtle changes or to erase fine lines. "Something like this is especially nice for an area like the crow's feet, which is a very delicate area where a subtle treatment is more effective," explains Smith. "If someone has very deep folds, micro Botox probably isn't going to cut it. I would offer this to someone with moderate to fine lines."
The FDA approved such usage in the late 1980s upon the discovery that Botox could stop ailments like blepharospasm (uncontrolled blinking) and strabismus (lazy eye). Doctors have been using Botox for years to successfully treat wrinkles and facial creases. In April 2002, Botox gained FDA approval for treatment of moderate-to-severe frown lines between the eyebrows - called glabellar lines. However, Botox is often used for other areas of the face as well.
[b] These values represent the prospectively planned method for missing data imputation a nd statistical test. Sensitivity analyses indicated that the 95% confidence interval excluded the value of no difference between groups and the p -value was less than 0.05. These analyses included several alternative missing data imputation methods and non-parametric statistical tests.
As with any drug, Allergan is legally required to make known Botox's most severe potential side effects, and in 2009 the FDA required Botox to bear a black-box warning--the strongest type of warning label given to any drug--cautioning that there was evidence the drug had been linked to serious side effects. With Botox, this includes effects spreading from the injection site to other parts of the body, causing muscle weakness, double vision and drooping eyelids.
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.
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.
Formation of neutralizing antibodies to botulinum toxin type A may reduce the effectiveness of BOTOX treatment by inactivating the biological activity of the toxin. The critical factors for neutralizing antibody formation have not been well characterized. The results from some studies suggest that BOTOX injections at more frequent intervals or at higher doses may lead to greater incidence of antibody formation. The potential for antibody formation may be minimized by injecting with the lowest effective dose given at the longest feasible intervals between injections.
University-based ophthalmologists in the USA and Canada further refined the use of botulinum toxin as a therapeutic agent. By 1985, a scientific protocol of injection sites and dosage had been empirically determined for treatment of blepharospasm and strabismus. Side effects in treatment of this condition were deemed to be rare, mild and treatable. The beneficial effects of the injection lasted only 4–6 months. Thus, blepharospasm patients required re-injection two or three times a year.
SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum/PA++++ Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+) and Essential Defense Broad Spectrum/PA++++ Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) are over-the-counter drug products that are formulated and marketed pursuant to the FDA's governing regulations set forth at 21 CFR § 352.
“We don’t believe Botox is expensive when you look at the value that we provide,” says Marc Forth, senior vice president of US marketing at Allergan, the maker of Botox. Botox halves migraine days in 50 percent of patients who get the injections, Forth says. “We believe that value is worth the tradeoff.” Allergan doesn’t have a say on step therapy policies. Insurers “ultimately make that call on their own,” Forth says.
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.
Once the protein stops functioning at the neuromuscular junction, it is broken down into its harmless components (amino acids) and either recycled for use in other proteins or excreted by the kidneys. "The bigger the muscle, the quicker you'll see motion return," says Rowe. "Likewise, the smaller the muscle, the longer the effect of botox lasts." It doesn't have a tolerance effect, either—your body never gets used to Botox.
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:
With this in mind, the average cost for treating forehead lines varies from approximately $200 to $600. Patients with fine lines or smaller facial muscles won’t require as many units of Botox to achieve a successful outcome, whereas patients with stronger facial muscles (such as pronounced corrugator muscles which cause deeper frown lines) could require more.
Onabotulinumtoxin A (trade name Botox) received FDA approval for treatment of chronic migraines on October 15, 2010. The toxin is injected into the head and neck to treat these chronic headaches. Approval followed evidence presented to the agency from two studies funded by Allergan showing a very slight improvement in incidence of chronic migraines for migraine sufferers undergoing the Botox treatment.
The company markets brand products in six therapeutic areas: aesthetics/dermatology/plastic surgery; neurosciences/CNS; eye care; women’s health and urology; GI and cystic fibrosis; and cardiovascular disease and infectious disease. The company's products include Botox (botulinum toxin), Namenda (memantine), Restasis (ciclosporin), Linzess (linaclotide), Bystolic (nebivolol), Juvederm (injectable filler), Latisse (bimatoprost), Lo Loestrin Fe, Estrace (estradiol), Teflaro (ceftaroline fosamil), Dalvance (dalbavancin, Ozurdex (dexamethasone), Optive, Natrelle, Viibryd (vilazodone), Liletta (levonorgestrel), Saphris (asenapine), Enablex (darifenacin), Actonel (risedronic acid), Androderm (testosterone), and Gelnique (oxybutynin).
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
Results can vary depending on who is performing the injection on the patient. It is very important to go to a physician who is experienced at this procedure, does it him- or herself (rather than having a nurse, physician's assistant [PA], or other nonphysician do it), and has a good reputation for performing this type of procedure. The manufacturers of Botox recommend physicians inject the medication themselves. As with most procedures, the skill of the practitioner is related to how often he or she performs the procedure.
Botox is injected in and around the head on an average of every three months. It blocks signals from nerves and paralyzes the muscles, ultimately preventing migraines. It is known to relax the muscles that usually contract during migraines. It’s also the only FDA-approved medication to prevent migraines before they even start! It’s known to prevent about nine migraines per month.
Dr. Matarasso says hardly a week goes by when he doesn’t see a patient with a botched Botox job. Why? People are getting it done by unexperienced, often unlicensed, practitioners who don’t know the shape of the face and how to correctly administer the toxin. “I just had a patient come in the other day who went to an ER doctor, and one that went to a psychiatrist,” he says. “They [also] have these Botox parties and I have seen scarring, significant bruising, not only functional, but aesthetic complications.”
When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal develop ment were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 2 times the human dose of 400 Units, based on Units/k g.
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 postinjection 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).
BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
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.
"We were very skeptical," says Edwin Chapman, a professor of neuroscience at the University of Wisconsin--Madison, after reading Caleo's study. But in August 2016, Chapman and his graduate student Ewa Bomba-Warczak published a study in the journal Cell Reports showing similar spreading effects in animal cells in the lab. For Chapman, it explained what he was hearing anecdotally from doctors: that Botox might be influencing the central nervous system and not just the area where it's being injected.
How long the results from a Botox treatment last depends on the dosage and application. If Botox is too diluted and you don't get the proper units of Botox injected, the results might not last very long at all. If you get Botox for the wrong kind of wrinkles (i.e. static wrinkles) or an improper dose for your anatomy, you might not see much improvement either. In general, if the right amount of Botox is injected by a skilled doctor in the right muscles, Botox results can last 3-4 months.
30+ year migraine warrior, wife, mother, corporate exec turned health advocate, Paula is Migraine Again Managing Editor and Chief Encouragement Officer. She champions patient's needs as an American Migraine Foundation Board Member, CHAMP Coalition Leader, IHS Patient Advocate and co-author of CaMEO and My Migraine Voice research studies. In addition to hosting the Migraine Again Podcast and producing the Migraine World Summit, Paula is a frequent speaker at industry, health care and public policy events. She's also the Founder and CEO of the World Health Education Foundation, a 501c3. Follow her on LinkedIn or Facebook.
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. 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. Similar effects had reportedly been observed by a number of independent groups (Brin, and the Columbia University group under Monte Keen.) 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). Subsequently, cosmetic use of botulinum toxin type A has become widespread. The results of Botox Cosmetic can last up to four months and may vary with each patient. 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.
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.
The most frequently reported adverse reactions following injection of BOTOX for adult lower limb spasticity appear in Table 17. Two hundred thirty one patients enrolled in a double-blind placebo controlled study (Study 6) received 300 Units to 400 Units of BOTOX, and were compared with 233 patients who received placebo. Patients were followed for an average of 91 days after injection.
When receiving Botox, it’s critical to know what you’re getting and to be sure that you get what you pay for. Usually, the cost of Botox is calculated on a per unit basis. This is the preferred option of many patients and surgeons as you only pay for the units of Botox used to treat any given area. This means that if you only require ten units to correct your forehead wrinkles, you simply pay for ten units at the specified price and that’s it.
The primary efficacy variable was wrist flexors muscle tone at week 6, as measured by the Ashworth score. The Ashworth Scale is a 5-point scale with grades of 0 [no increase in muscle tone] to 4 [limb rigid in flexion or extension]. It is a clinical measure of the force required to move an extremity around a joint, with a reduction in score clinically representing a reduction in the force need ed to move a joint (i.e., improvement in spasticity).
"The difference between using a cannula and a 'needle injection' technique is cannulas are a blunt tip needle that lets us place filler on a plane that allows it to last longer," explains Goodman. "They look better and preserve the 'untouched look' we're known for. Also, it's a more advanced technique that ensures the patient will not leave the office bruised."
Not much. Results begin to show in a couple of days and develop gradually over the course of two weeks. "I tell anyone preparing for a big event to have shots two weeks ahead of time," says Kane. Some observers believe Dysport sets in faster than Botox, but that has not been proven in a study. Patients taking medications that contain aspirin or NSAIDs can develop pinpoint blue bruising. Patients can wear makeup immediately but should avoid heavy workouts for 24 hours, says Carruthers.
When BOTOX (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were ob served at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) is approximately equal to the human dose of 400 Units, on a body weight basis (Units/kg).
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.
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.
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.
Botox takes three to five days to kick in, with the full effect becoming apparent within two weeks. Some people say they know when it’s taken effect because it suddenly feels like there’s duct tape on their forehead. “Botox will affect the way your facial muscles move, and it can feel funny when you can’t move your face to make a particular expression,” Dr. Shainhouse explains. “Also, sometimes injection of Botox in one area can affect another area—for example, injecting too low on the forehead to reduce wrinkles above the brows can actually end up lowering the brows, which is not always ideal. You may also experience a super-tight feeling in the beginning, before your body has time to adjust to the toxin.” These are the 50 things your surgeon won’t tell you.
Potential Botox side effects include pain at the injection site, infection, inflammation, swelling, redness, bleeding and bruising. Some of these symptoms may indicate an allergic reaction; other allergy symptoms are itching, wheezing, asthma, a rash, red welts, dizziness and faintness. Tell your doctor immediately if you have any breathing issues or a faint or dizzy feeling.
According to Ravitz, it's very effective among a large sampling of her patients and is usually very well tolerated. She says some of her patients find that it even eliminates the need for medication, which is a huge deal. However, she also says, "About 7 to 10 percent of my patients find that it’s not effective and they actually feel worse during that time." As with any medical procedure, everybody (and everyone's actual body) is different and will respond to treatment differently, and it's best to do a healthy amount of research and thoroughly talk to your doctor about your body and medical history before making a decision.
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.