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.”
They affect 39 million folks in the U.S., 4 million of whom deal with daily pain. Chronic migraines can severely inhibit daily life, and when I started to feel like my bad days were outnumbering my good, I knew I needed to find a solution. Botox had been suggested to me multiple times before by friends, family, and doctors, and though it took quite a while to get it approved by insurance and find a provider I trusted, my migraines were making it hard to live a normal life, so I decided to try it out.
Of 1242 overactive bladder patients in placebo-controlled clinical studies of BOTOX, 41.4% (n=514) were 65 years of age or older, and 14.7% (n=182) were 75 years of age or older. Adverse reactions of UTI and urinary retention were more common in patients 65 years of age or older in both placebo and BOTOX groups compared to younger patients (see Table 18). Otherwise, there were no overall differences in the safety profile following BOTOX treatment between patients aged 65 years and older compared to youn ger patients in these studies.
The cosmetic benefits came to light in the 1990s by happy coincidence. “The aesthetic indications were purely happenstance,” says board-certified surgeon and clinical professor Seth L. Matarasso, MD, who has been treating his clients with Botox since the 1990s but is not affiliated with the brand. “Dr. [Jean] Carruthers was working with patients with strabismus...[and] with diplopia [double vision], and her patients were coming in and saying, ‘Gee, my wrinkles are better.'" Soon enough, doctors were using Botox for what it is most commonly associated with today — nixing lines.
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.
A recent encounter with one of my headache patients got me thinking. I am treating this young woman for chronic migraine with BOTOX injections. She told me that one of her other physicians had been surprised to hear about this use for onabotulinumtoxin A. According to my patient, the gastroenterologist’s words were, “BOTOX for migraines? I’ve never heard of that.”
In response to the occurrence of these side effects, in 2008 the U.S. Food and Drug Administration notified the public of the potential dangers of the botulinum toxin as a therapeutic. Namely, they warned that the toxin can spread to areas distant from the site of injection and paralyze unintended muscle groups, especially when used for treating muscle spasticity in children treated for cerebral palsy. In 2009, the FDA announced that boxed warnings would be added to available botulinum toxin products, warning of their ability to spread from the injection site. Additionally, the FDA announced name changes to several botulinum toxin products, meant to emphasize that the products are not interchangeable and require different doses for proper use. Botox and Botox Cosmetic were renamed onabotulinumtoxinA, Myobloc was renamed rimabotulinumtoxinB, and Dysport name renamed abobotulinumtoxinA. In conjunction with this, the FDA issued a communication to health care professionals reiterating the new drug names and the approved uses for each. A similar warning was issued by Health Canada in 2009, warning that botulinum toxin products can spread to other parts of the body.
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.
Botox treatments can help reduce symptoms of migraine headaches, including nausea, vomiting, and sensitivity to lights, sounds, and smells. After you receive Botox injections, it may take as long as 10 to 14 days for you to experience relief. In some cases, you may not experience any relief from your symptoms following your first set of injections. Additional treatments may prove more effective.
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Unopened vials of BOTOX should be stored in a refrigerator (2° to 8°C) for up to 36 months. Do not use after the expiration d ate on the vial. Administer BOTOX within 24 hours of reconstitution; during this period reconstituted BOTOX should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX should be clear, colorless, and free of particulate matter.
A BOTOX “treatment” consists of 31 injections to the head and neck areas, if adherence to the FDA approved protocol is followed. Except for injection into the procerus, which is in the midline, all others are paired sets of injections on the left and right sides. Muscles included are the frontalis and temporalis areas as well as the occipitalis, upper cervical paraspinals, and trapezii. The amount injected at each of the 31 injection sites is small—5 units of BOTOX in a volume of 0.1 mL normal saline or sterile water. A total of 155 units is are typically used.
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].
Getting Botox takes only a few minutes and no anesthesia is required. Botox is injected with a fine needle into specific muscles with only minor discomfort. It generally takes three to seven days to take full effect and it is best to avoid alcohol at least one week prior to treatment. Aspirin and anti-inflammatory medications should be stopped two weeks before treatment as well in order to reduce bruising.
According to the PREEMPT injection paradigm, 5 units of onabotulinumtoxinA is to be administered to two sites on each side for a total dose of 20 units across four sites in the cervical paraspinal muscle group near the midline. The first injection site is approximately 1 cm left of the midline of the cervical spine and approximately 3 cm (2 fingerbreadths) inferior to the occipital protuberance. The second site is measured approximately 1 fingerbreadth diagonally up at a 45° angle from the first injection. The injections should be administered in the most superficial aspect of the muscle, angling the needle 45° and superiorly. To aid in the placement of the injections, the patient should be positioned upright with the head in a neutral position. If the neck is flexed too far forward, injections may be too deep. Injections that are too low or too deep in this muscle group can lead to muscle weakness and neck pain. Injectors should use a suboccipital approach to ensure that the injection sites are not too low. In addition, a horizontal line can be visualized across the neck, approximately 2 fingerbreadths down from the occipital protuberance, to make certain the injections remain above the line and are not administered too low in the neck. The higher these injections are, the more likely that they will be in the muscle fascial condensation, which will minimize the potential for neck weakness. These injections should not be done below the hairline. Patients who have trigger points in the neck should not be injected at these sites as these are generally areas where muscles may be weakened and injections of onabotulinumtoxinA at these sites might worsen their neck issues.
BOTOX® treats the symptoms of severe underarm sweating when topical medicines do not work well enough in people 18 years and older. It is not known whether BOTOX® is safe or effective for severe sweating anywhere other than your armpits. BOTOX® treatments temporarily block the chemical signals from the nerves that stimulate the sweat glands, resulting in reduced sweating.