I don’t know what’s harder, being a mom or living with migraine. Having both can be overwhelming. Over the years, as a stay-at-home mom of two and chronic migraine fighter, I have learned to adapt my life and my children’s lives to migraine. I alter my family’s schedule around my children’s naps, meals and moods, while also keeping in mind my migraine attacks, sensitivities, triggers and abilities.
There are eight types of botulinum toxin, named type A–H. Types A and B are capable of causing disease in humans, and are also used commercially and medically. Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals. Type H is considered the deadliest substance in the world – an injection of only 2 ng can cause death to an adult. Botulinum toxin types A and B are used in medicine to treat various muscle spasms and diseases characterized by overactive muscle. Commercial forms are marketed under the brand names Botox and Dysport, among others.
But for some conditions, step therapy can be downright harmful. In a 2016 op-ed in The Boston Globe, a patient with ulcerative colitis wrote that his health insurance forced him to try a cheaper treatment for six months, instead of the pricier meds his doctor wanted to prescribe. In those six months, his colon deteriorated so badly it had to be removed.
When asked how often he turns people away, Dr. Matarasso says: “I turned someone away today. I had a gentleman come in, he was an appropriate candidate anatomically, he had some deep lines in his forehead, but his expectations were unrealistic. He wanted every line erased, and I said, ‘No, you are going to look a little mask-like.’ I gave him a brochure and said, 'Go home and think about it.'”
Baby Botox can also be used as an upkeep strategy. "I really think of it as small maintenance doses of Botox over time instead of standard doses given at three- to six-month intervals," says Smith. "The other term that describes this well is 'tweakment' — subtle changes done over a longer period of time using lower doses of product at each treatment."
Unlike some resurfacing or surgical procedures, after which there is possible pigmentation or scarring, when Botox is done correctly, it can be done on all skin tones. “This is a procedure [and] product that crosses all divides,” says Dr. Matarasso. “Men, women, Caucasian, African-American, Asian, Indian. I don’t think there is a demographic that has not enjoyed the benefit of this product.”
Botox for migraines has been something that has flown under the radar, as many people know Botox as a procedure simply aimed at hiding fine lines. We turned to Matthew S. Robbins, MD, director of inpatient services at Montefiore Headache Center and the chief of neurology at the Jack D. Weiler Hospital, Montefiore, to break down the procedure for us. Scroll down to see what he has to say.
Both Aetna and HealthPartners tell The Verge in an email that they don’t require patients to try verapamil specifically. “Verapamil is just one of many options available to treat migraines. Some are FDA-approved, others are not,” says Becca Johnson, a spokesperson for HealthPartners. Patients are required to try other oral medications because they’re either cheaper or not as invasive as getting Botox injections. “The rationale is that these medications are generally effective and safe,” says Ethan Slavin, a spokesperson for Aetna.
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 stays only where injected, it does not roam through the body. "If I inject it in your face, it's not going to work [or show up in] your toe," says Rowe. "It does not have a systemic effect." However, it may migrate up to 3 cm from where it was injected. But even if some molecules were to go into the bloodstream and travel to distant sites in the body, the cosmetic doses (typically less than 100 units) used are significantly lower than the toxic dose that would be harmful systemically (2,500-3,000 units).
Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
Allergan has a deep commitment to the health and well-being of patients who use our products and the global communities where we operate. We are focused on access to our medicines, as well as environmental, health and sustainability initiatives. In 2016, Allergan introduced Our Social Contract with Patients, focused on four areas – Invest & Innovate, Access & Pricing, Quality & Safety, and Education -- where Allergan is committed to doing what is right for patients and society
Patients with compromised respiratory status treated with BOTOX for spasticity should be monitored closely. In a double-blind, placebo-controlled, parallel group study in patients treated for upper limb spasticity with stable reduced pulmonary function (defined as FEV1 40-80% of predicted value and FEV1/FVC ≤0.75), the event rate in change of Forced Vital Capacity (FVC) ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 5).
Sometimes, because of these policies, patients are put on meds that are not approved by the FDA for the treatment of migraines, like the antidepressant amitriptyline and the high blood pressure drug verapamil. “In my experience, [verapamil is] not very effective,” says Elizabeth Loder, chief of the headache division at Brigham and Women’s Hospital in Boston and the former president of the American Headache Society. For the insurance companies, that doesn’t seem to matter. “It’s frustrating to patients, especially when it seems like some of the treatments that they’re required to try have a lot of side effects and haven’t really been tested that carefully for migraines.”
The number of headache days determines whether the patient has episodic migraine (EM) (14 or fewer headache days a month) or CM (more than 15 days of headache a month). The best method of determining the actual number of headache days is to subtract this from the number of completely headache-free days in a month. If headache is present on more than half the days in the month, and there are migraine features on at least 8 days a month, the condition is termed CM. The migraine features only have to be present on 8 days out of the month and not on every headache day. The other headache days in this condition are considered to be milder forms of migraine, and they do not have all the typical migraine features. If headache is present on fewer than 15 days a month, this is referred to as EM. EM can transform to CM over time. If analgesics are used on 10 or more days per month, this can lead to a transformation to CM. The patient’s headache pattern over a 12-month period should be determined, and during this time, there should be at least 3 months with 15 headache days; 8 of these days should meet migraine criteria.1-3
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.
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.
The company markets brand products in six therapeutic areas: aesthetics/dermatology/plastic surgery; neurosciences/CNS; eye care; women’s health and urology; GI and cystic fibrosis; and cardiovascular disease and infectious disease. The company's products include Botox (botulinum toxin), Namenda (memantine), Restasis (ciclosporin), Linzess (linaclotide), Bystolic (nebivolol), Juvederm (injectable filler), Latisse (bimatoprost), Lo Loestrin Fe, Estrace (estradiol), Teflaro (ceftaroline fosamil), Dalvance (dalbavancin, Ozurdex (dexamethasone), Optive, Natrelle, Viibryd (vilazodone), Liletta (levonorgestrel), Saphris (asenapine), Enablex (darifenacin), Actonel (risedronic acid), Androderm (testosterone), and Gelnique (oxybutynin).
Reduced blinking from BOTOX injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Vigorous treatment of any epithelial defect should be employed. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other me ans.
Botox injections for migraines have been proven to reduce the intensity and duration of migraines for those who suffer. Botox was developed in the 1970s by an ophthalmologist who was looking to develop a treatment for strabismus (crossed eyes). This simple migraine treatment was discovered accidentally when people undergoing plastic surgery also experienced migraine relief. While they don’t work for everyone, Botox injections for migraines offer another way to approach treatment of migraine headaches.
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.
Not a Botox patient? Listen anyway. This is good practice for asking the price for other medical procedures like an MRI or a colonoscopy, where the information can be much harder to get. The common replies you could get: “What’s your insurance?” “We can’t tell you because it depends on your deductible.” “We don’t know.” “You’ll have to call billing.”
Botulinum toxin (BTX) is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis. Infection with the bacterium causes the disease botulism. The toxin is also used commercially in medicine, cosmetics and research.
The efficacy and safety of BOTOX for the treatment of primary axillary hyperhidrosis were evaluated in two randomized, multi center, double-blind, placebo-controlled studies. Study 1 included adult patients with persistent primary axillary hyperhidrosis who scored 3 or 4 on a Hyperhidrosis Disease Severity Scale (HDSS) and who produced at least 50 mg of sweat in each axilla at res t over 5 minutes. HDSS is a 4-point scale with 1 = “underarm sweating is never noticeable and never interferes with my daily activities”; to 4 = “underarm sweating is intolerable and always interferes with my daily activities”. A total of 322 patients were randomized in a 1:1:1 ratio to treatment in both axillae with either 50 Units of BOTOX, 75 Units of BOTOX, or placebo. Patients were evaluated at 4-week intervals. Patients who responded to the first injection were re-injected when they reported a re-increase in HDSS score to 3 or 4 and produced at least 50 mg sweat in each axilla by gravimetric measurement, but no sooner than 8 we eks after the initial injection.
Some industry insiders say it's not unusual, if still legally murky, for drug-company representatives and doctors to share information with one another about the different ways an approved drug may be used. If a doctor notices that, say, a treatment for crossed eyes also "takes the lines out," he may mention it to the representative from whom he buys the drugs. That rep may share that with another of his clients, and so on.
This is because the discretionary procedures tend to be out of pocket, and providers are used to answering the question: how much does it cost? An MRI, on the other hand, might have several prices: A sticker price, a negotiated or reimbursed rate (what the insurance company pays), the rate that Medicare and Medicaid pay for treatments for people who are older and those who have low income, an out-of-network price, and so on. We know about this because we’ve done pricing surveys for about 35 common procedures in seven U.S. metro areas, collecting cash or self-pay prices for both medically necessary procedures (an MRI, a colonoscopy) and discretionary procedures (Botox, Lasik).
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.
Spread of toxin effects.The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
I tell my patients that it is not the total price that is important, but how many units are used. For instance, if a patient goes to a spa and pays $150 per area, that may sound like a great deal. However, when the patient ask how long the treatment is supposed to last, the spa responds "2 months". I have seen that many of those less expensive treatments often consist of around 10 units (and therefore carrying a "non-deal" $15 cost per unit!). So, what initially looks like a great bargain, is in fact just a treatment with an inadequate amount of Botox. Always ask your injector how many units they are using, so you can determine what price/unit you are getting. Experienced injectors know that there is no such thing as a standard amount of units, as everyone's facial anatomy and muscular strengths are variable, even from one side of the face to the other.
Botulinum toxin exerts its effect by cleaving key proteins required for nerve activation. First, the toxin binds specifically to nerves which use the neurotransmitter acetylcholine. Once bound to the nerve terminal, the neuron takes up the toxin into a vesicle. As the vesicle moves farther into the cell, it acidifies, activating a portion of the toxin which triggers it to push across the vesicle membrane and into the cell cytoplasm. Once inside the cytoplasm, the toxin cleaves SNARE proteins preventing the cell from releasing vesicles of neurotransmitter. This stops nerve signaling, leading to paralysis.
Botox® neurotoxin treatment helps control the symptoms of severe underarm sweating when topical medicines do not work well enough by temporarily blocking the chemical signals from the nerves that stimulate the sweat glands. When the sweat glands don’t receive chemical signals, the severe sweating stops. Botox® injections are expected to temporarily stop the production of excessive sweat in the treated areas only. Sweat continues to be produced elsewhere.
Most insurance providers now cover the expense of Botox injections when they’re used to treat chronic migraines. If you don’t have insurance, or your insurance won’t cover the cost of the procedure, it may cost you several thousand dollars. Before you begin receiving injections, talk to your insurance company. In some cases, they may require you to undergo other procedures or tests before they will cover the costs of Botox treatments.
The recommended dilution is 200 Units/2 mL, 200 Units/4 mL, 100 Units/1 mL, or 100 Units/2 mL with preservative-free 0.9% Sodium Chloride Injection, USP, depending on volume and number of injection sites desired to achieve treatment objectives (see Table 1). In general, no more than 50 Units per site should be administered using a sterile needle (e.g., 25-30 gauge) of an appropriate length. Localization of the involved muscles with electromyographic guidance may be useful.
Onabotulinumtoxin A (trade name Botox) received FDA approval for treatment of chronic migraines on October 15, 2010. The toxin is injected into the head and neck to treat these chronic headaches. Approval followed evidence presented to the agency from two studies funded by Allergan showing a very slight improvement in incidence of chronic migraines for migraine sufferers undergoing the Botox treatment.
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.