Botox injections use onaboutlinumtoxin A, also known as the botulinum toxin, injected in small amounts to certain points in the head to treat migraine headaches, tension headaches, and chronic daily headaches. This treatment has been shown to be most effective for headaches that are located in the forehead and neck. Botox has also been used to treat the following conditions:
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.
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.”
Step therapy is largely unregulated both at the state and federal level, though individual states have started to pass legislation to limit step therapy and protect patients: 19 US states, including California, Mississippi, and Illinois, have laws that require insurance companies to grant certain exemptions or to review appeals from doctors within 72 hours so patients can get a waiver. But even then, getting a waiver isn’t always easy.
With the outbreak of World War II, weaponization of botulinum toxin was investigated at Fort Detrick in Maryland. Carl Lamanna and James Duff developed the concentration and crystallization techniques that Edward J. Schantz used to create the first clinical product. When the Army’s Chemical Corps was disbanded, Schantz moved to the Food Research Institute in Wisconsin, where he manufactured toxin for experimental use and generously provided it to the academic community.
So what exactly are you putting into your face? John Paul Tutela, MD, a board certified plastic surgeon, explains, “Botox is a cosmetic injectable neurotoxin that is a very diluted form of Botulinum Toxin, which is found in the bacteria Clostridium botulinum. In this diluted format, it is used to relax your muscles—typically in your forehead, in between your eyebrows, and around your eyes.” The idea is that if you temporarily block local nerve impulses to specific muscles within your face, you won’t make certain facial expressions, so you won’t form the wrinkles that come with them, explains dermatologist Tsippora Shainhouse, MD, FAAD. These are the 7 signs you’re ready for Botox? (And 6 signs you aren’t.)
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).
"Botox inactivates the muscle," Rowe tells SELF, "and therefore the muscle doesn't fire and pull on skin, thus reducing animation." However, when I asked Sobel what was happening during the exact incubation, he told SELF that "I'm not sure if anyone can give you an answer&we've noticed that when we inject it, it just takes three of four days for you to see the muscle contract."
The more areas that need treatment the higher the cost of treatment. The reason is also simple – the cost of Botox or Dysport that the doctor pays for the drugs is relatively expensive and therefore that cost is obviously passed along to the patient. A second 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 determines the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price for injections you should question whether or not you are receiving a very dilute injection.This dilute mixture typically does not produce the same effect as a more or not concentrated (more expensive) injection and does not last as long.
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.
Currently, there are several anti-CGRP treatments undergoing clinical trials. Some of these treatments involve monoclonal antibodies, which reduce the activity of CGRP, potentially leading to fewer migraine attacks. One of these anti-CGRP monoclonal antibodies, erenumab (Aimovig™), has been approved by the Federal Drug Administration (FDA) and is now available for patients. A second agent, fremanezumab (Ajovy™), was approved in September 2018. A week later, the FDA approved galcanezumab (Emgality™), making it the third anti-CGRP treatment currently on the market. Results from the clinical trials involving anti-CGRP antibodies have shown that about 50 percent of patients will have at least a 50 percent reduction in migraine days. “If you think about someone who has 20 migraine days per month, they have a 50 percent chance of having 10 or less migraine days,” Dr. Starling says. “We think that there are even these super-responders who have a 75 percent response rate, as well as super-super-responders who actually go into remission.” The results from these clinical trials are very promising, Dr. Starling adds. “The adverse events have been very minimal and the efficacy has been very good. It’s all looking up.” Dr. Starling says that although these medications are available, what really needs to be looked at is how to make them truly accessible for patients. Erenumab can cost about $7,000 per year without insurance coverage. “Insurance coverage is very, very key for the majority of our patient population,” she says. “Because the medications just came out on the market, there are still a lot of unknowns about insurance coverage.”
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).
Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
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.
Two double-blind, placebo-controlled, randomized, multi-center clinical studies were conducted in patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition who were either spontaneously voiding or using catheterization (Studies NDO-1 and NDO-2). A total of 691 spinal cord injury (T1 or below) or multiple sclerosis patients, who had an inadequate response to or were intolerant of at least one anticholinergic medication, were enrolled. These patients were randomized to receive either 200 Units of BOTOX (n=227), 300 Units of BOTOX (n=223), or placebo (n=241).
Botox must be used only under a doctor's care. It's important that injections be placed precisely in order to avoid side effects. Botox therapy can be dangerous if it's administered incorrectly. Ask for a referral from your primary care doctor or look for a doctor who specializes in your condition and who has experience in administering Botox treatments.
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.
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.
Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.
Safety and effectiveness of BOTOX have not been established for the treatment of other upper or lower limb muscle groups. Safety and effectiveness of BOTOX have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX is not intended to substitute for usual standard of care rehabilitation regimens.
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.
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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.
If you experience migraine symptoms on 15 or more days each month, you have chronic migraines. Over-the-counter or prescription medications may help ease some of your symptoms, but some patients don’t respond well to pain relievers. In some cases, your doctor may prescribe preventive medicines, which are designed to reduce the frequency and severity of your symptoms. According to research published in the journal Neurology, only about one-third of patients with chronic migraines take preventive medicines.