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.”
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.
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.
Key secondary endpoints included Physician Global Assessment, finger flexors muscle tone, and thumb flexors tone at Week 6. The Physician Global Assessment evaluated the response to treatment in terms of how the patient was doing in his/her life using a scale from -4 = very marked worsening to +4 = very marked improvement. Study 1 results on the primary endpoint and the key secondary endpoints are shown in Table 26.
In a study to evaluate inadvertent peribladder administration, bladder stones were observed in 1 of 4 mal e monkeys that were injected with a total of 6.8 Units/kg divided into the prostatic urethra and proximal rectum (single administration). No bladder stones were observed in male or female monkeys following injection of up to 36 Units/kg (~12X the highest human bladder dose) directly to the bladder as either single or 4 repeat dose injections or in female rats for single injections up to 100 Units/kg (~33X the highest human bladder dose).
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
I had a consult and the doctor quickly realized that I was a candidate for Botox. He ordered an MRI and doppler of my brain to make sure everything else was A-OK, and then the rest was just waiting on my insurance company. With Botox (I’m not sure if it’s all Botox or just prescription), the insurance company orders it from a pharmacy and sends it to the doctor.
Injections: They're a popular topic and yet still shrouded in mystery and a veritable amount of secrecy. Most of us venture to a consultation or decide against them without actually knowing much information—how much they cost, what to expect during an appointment, or what the results will be. Because we're not willing to openly and freely discuss it (or have been taught not to), more often than not these conversations occur through a series of unanswered questions. Like sexual education, relying on abstinence is never going to be enough. We want to feel confident, look good, and make our own choices, and as such, that often leads to investing in modern skincare techniques.
Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.
But it could be something else altogether. In 2008, Matteo Caleo, a researcher at the Italian National Research Council's Institute of Neuroscience in Pisa, published a controversial study showing that when he injected the muscles of rats with Botox, he found evidence of the drug in the brain stem. He also injected Botox into one side of the brain in mice and found that it spread to the opposite side. That suggested the toxin could access the nervous system and the brain.
But even if the laws remain unchanged, as long as off-label uses are permitted by law, expect doctors to keep pushing the boundaries of Botox's applications--sometimes in the name of medical progress and sometimes with remarkable results.Norman Rosenthal, the Maryland psychiatrist who recommended Botox for his suicidal patient, says he's seen the upside firsthand. The patient, persuaded by Rosenthal, did indeed get Botox shots on his forehead and between his brows. Days later, Rosenthal got an email from the patient. It was a thank-you note. Finally, the patient wrote, he was feeling better.
In 1950, pharmacist Gavin S. Herbert established Allergan Pharmaceuticals, Inc. Allergan focused on the discovery and development of novel formulations for specialty markets, as well as intimate collaboration with physicians and the scientific community. In 1953, Allergan produced eye drops and formulated new products such as the first cortisone eye drop to treat allergic inflammation and the first ophthalmic steroid decongestant.
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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].
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.