But today it's the medical uses of the drug that are the great moneymaker, in part because doctors are getting a better handle on how to use it. Botulinum toxin type A is one of seven neurotoxins produced from Clostridium botulinum. Contracting botulism is bad news: it can cause blurred vision, persistent trouble swallowing and worse. In one recent case, close to 30 people were hospitalized in Ohio in 2015 after attending a church potluck. One person died. The outbreak was ultimately attributed to a potato salad made from improperly home-canned potatoes that were harboring the bacteria. Given its level of toxicity, some countries have even explored its potential use as a bioweapon.
In detrusor overactivity associated with neurologic condition patients with analyzed specimens in the drug development program (including the open-label extension study), neutralizing antibodies developed in 3 of 300 patients (1.0%) after receiving only BOTOX 200 Unit doses and 5 of 258 patients (1.9%) after receiving at least one 300 Unit dose. Following development of neutralizing antibodies in these 8 patients, 4 continued to experience clinical benefit, 2 did not experience clinical benefit, and the effect on the response to BOTOX in the remaining 2 patients is not known.
Before I could try Botox, my health insurance — Cigna — required me to try and fail at least two other meds. I tried tricyclic antidepressants, which made me groggy and turned my brain into molasses, and beta blockers, a class of drugs used for high blood pressure and heart problems. (All treatments to prevent migraines are borrowed from other conditions, except a new class of drugs that was just approved by the Food and Drug Administration.) The beta blockers worked for a few months: they slightly reduced the number of migraines and made the headaches more bearable. But late last year, the migraines became chronic again — I had more than 15 in a month. That’s when my neurologist said: “I think it’s time to try Botox.”
Botox is said to decrease the frequency of migraine days by an average of 50 percent for those who suffer chronically (people who experience 15 or more headache days per month). After going through hell with my insurance to get approval, I scheduled an appointment with New York City neurologist and pain-management specialist Risa Ravitz. She was kind enough to speak with me about the wonders of Botox while we did my first procedure in June 2017.
Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
The migraines started later in life, before my lupus diagnosis. While sometimes they’d come out of the blue or I’d wake up with them, other times I’d see them coming. From a neurologist’s suggestion, I learned some of my “triggers” such as weather changes (specifically, drops in barometric pressure and incoming storms), hormonal changes and dairy. This past year I significantly reduced my dairy intake and although that didn’t eliminate the migraines, if I did eat dairy, I was sure to get one. Many of my migraines would also start as tension headaches. My neck is always extremely tight and eventually the constant tightness causes a migraine. Due to this, my old rheumatologist suggested taking a muscle relaxer at the beginning of a headache or before bed to keep my muscles from tensing up overnight and preventing a migraine. It worked sometimes… but definitely not enough.
The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan's products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex.
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.
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.
Absolutely. Botox (and competitors like Dysport and Xeomin, which will be widely available next January) are highly purified toxins that can temporarily erase or reduce horizontal forehead lines, vertical frown lines, and crow's-feet. "The injections slow muscles that contract hundreds of times a day, eventually etching lines in the skin," says New York City plastic surgeon Michael Kane, author of The Botox Book (St. Martin's Press). Botox can also lift the corners of the mouth that sag with age, smooth out the "pin cushion" look in some chins, soften smoker's lines around the mouth, and soften vertical neck cords.
When women in their 20's first consider getting Botox, prevention is often the primary factor, since the early signs of aging—such as crow's feet, forehead wrinkles, and fine lines—are beginning to show. "Lines get deeper and deeper with age," explains Wexler. "If you start [getting Botox] early enough and it's done properly, you're not going to need [as much] in the future." For younger patients wary of the frozen look—remember, youthful faces move—Wexler likes to employ lower doses of Botox via ultra-targeted micro injections administered on specific areas of the face such as the forehead, brows, or around the eyes.
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.
But in a recent Fat Mascara podcast, NYC dermatologist Pat Wexler, MD, said this is a myth. And Dr. Matarasso falls somewhere in-between. “For aesthetic or cosmetic reasons, does a 19-year-old need this? No. Does a 26-year-old need this for aesthetic purposes? Highly doubtful. But, hey, listen, if you are like, ‘I am looking at my parents, I am looking at my genes, and I want to stay proactive,’ it is not unreasonable to introduce it in small amounts.”
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.
In 1998, David E.I. Pyott became CEO of Allergan. He was enthusiastic about Botox's wrinkle-reducing potential, he says, and pushed the company to conduct a series of studies on the matter. In 2002, Botox earned FDA approval for so-called frown lines--wrinkles between eyebrows--marking the first time a pharmaceutical drug was given the green light for a strictly cosmetic purpose. In 2001, the year before Botox was approved for wrinkles, it generated about $310 million in sales. By 2013, the year it was approved for overactive bladder, Allergan reported nearly $2 billion in revenue from Botox.
The recommended dose is 50 Units per axilla. The hyperhidrotic area to be injected should be defined using standard staining techniques, e.g., Minor's Iodine-Starch Test. The recommended dilution is 100 Units/4 mL with 0.9% preservative -free sterile saline (see Table 1). Using a sterile 30 gauge needle, 50 Units of BOTOX (2 mL) is injected intradermally in 0.1 to 0.2 mL aliquots to each axilla evenly distributed in multiple sites (10-15) approximately 1-2 cm apart.
Other things to know about Botox treatments: Some providers charge a consultation fee, which is waived if you choose to proceed with the injections but charged if you decline. Also, who is doing the injection? Make sure it’s a trained, certified professional. As in many other things, training and credentials are important. In some practices, a junior employee may perform the procedure for a lesser rate. Make sure that’s what you want.
Most people tolerate the injection discomfort well. But you may want your skin to be numbed beforehand, especially if your palms or soles are being treated for excessive sweating. Your doctor might use one or more of various methods available to numb the area, such as topical anesthesia, ice and vibration anesthesia, which uses massage to reduce discomfort.
Can you use Botox under your eyes? Botox is often used to treat lines and wrinkles around the eyes and mouth. Can it also reduce dark circles or bags under the eyes? Using Botox under the eyes is not approved in the U.S. and researchers are unsure how well it may work and what side effects may occur. Here, learn about the procedure and its alternatives. Read now