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.
In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in wee kly frequency of incontinence episodes were observed for BOTOX (200 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 we re also observed. These primary and secondary endpoints are shown in Tables 21 and 22, and Figures 7 and 8.
BOTOX increases the incidence of urinary tract infection [see ADVERSE REACTIONS]. 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 t reatment should only be considered when the benefit is likely to outweigh the potential risk.
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).
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.
The results showed that 34% of those who responded and tried Botox said it significantly helped them. Sixteen percent reported a slight benefit. Nine percent stated that it didn’t help at all. Eleven percent stated that they would like to try Botox but it is too expensive. About 10% said they had no plans to try Botox, and 18% said they hadn’t tried it yet.
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.
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.
Botulinum toxin produced by Clostridium botulinum is the cause of botulism. Humans most commonly ingest the toxin from eating improperly-canned foods in which C. botulinum has grown. However, the toxin can also be introduced through an infected wound. In infants, the bacteria can sometimes grow in the intestines and produce botulinum toxin within the intestine and can cause a condition known as floppy baby syndrome. In all cases, the toxin can then spread, blocking nerves and muscle function. In severe cases, the toxin can block nerves controlling the respiratory system or heart, resulting in death. Botulism can be difficult to diagnose, as it may appear similar to diseases such as Guillain–Barré syndrome, myasthenia gravis, and stroke. Other tests, such as brain scan and spinal fluid examination, may help to rule out other causes. If the symptoms of botulism are diagnosed early, various treatments can be administered. In an effort to remove contaminated food which remains in the gut, enemas or induced vomiting may be used. For wound infections, infected material may be removed surgically. Botulinum antitoxin is available and may be used to prevent the worsening of symptoms, though it will not reverse existing nerve damage. In severe cases, mechanical respiration may be used to support patients suffering from respiratory failure. The nerve damage heals over time, generally over weeks to months. With proper treatment, the case fatality rate for botulinum poisoning can be greatly reduced.
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.
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.
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibo dy) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to onabotulinumtoxinA in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
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.
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.
Intradetrusor injection of BOTOX is contraindicated in patients with overactive bladder or detrusor overactivity associated with a neurologic condition who have a urinary tract infection. Intradetrusor injection of BOTOX is also contraindicated in patients with urinary retention and in patients with post-void residual (PVR) urine volume >200 mL, who are not routinely performing clean intermittent self-catheterization (CIC).
Study 2 compared 3 doses of BOTOX with placebo and included 91 patients [BOTOX 360 Units (N=21), BOTOX 180 Units (N=23), BOTOX 90 Units (N=21), and placebo (N=26)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone) who were at least 6 weeks post-stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimis, flexor carpi radialis, flexor carpi ulnaris, and bic eps brachii (see Table 27).
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.
Focal Spasticity is a condition in which certain muscles in your body become stiff or tight. It is caused by damage to parts of the central nervous system that control voluntary movements. When this happens, your nerves send continuous messages to your muscles telling them to contract, or tighten. If you or someone you care for has stiffness in the muscles of the elbow, wrist, fingers, thumb, ankle, or toes, it could be Focal Spasticity.1