Study 2 compared 3 doses of BOTOX with placebo and included 91 patients [BOTOX 360 Units (N=21), BOTOX 180 Units (N=23), BOTOX 90 Units (N=21), and placebo (N=26)] with upper limb spasticity (expanded Ashworth score of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone) who were at least 6 weeks post-stroke. BOTOX and placebo were injected with EMG guidance into the flexor digitorum profundus, flexor digitorum sublimis, flexor carpi radialis, flexor carpi ulnaris, and bic eps brachii (see Table 27).
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.”
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions a ssociated with the unapproved uses of BOTOX. The safety and effectiveness of BOTOX for unapproved uses have not been established.
Facelift: What you need to know A facelift aims to make the face look more youthful. The procedure can remove excess skin from the face and smooth wrinkles. However, it may not be suitable for everyone. Complications can occur, for example, infections, especially in people with existing health conditions. Relapse and scarring are also possible. Read now
Botulinum toxin is one of the most poisonous substances known to man. Scientists have estimated that a single gram could kill as many as 1 million people and a couple of kilograms could kill every human on earth. In high concentrations, botulinum toxin can result in botulism, a severe, life-threatening illness. Botulism, left untreated, may result in respiratory failure and death. Despite botulinum toxin being so toxic, Botox is in huge demand.
In general, adverse reactions occur within the first week follo wing injection of BOTOX and while generally transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.
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.
30+ year migraine warrior, wife, mother, corporate exec turned health advocate, Paula is Migraine Again Managing Editor and Chief Encouragement Officer. She champions patient's needs as an American Migraine Foundation Board Member, CHAMP Coalition Leader, IHS Patient Advocate and co-author of CaMEO and My Migraine Voice research studies. In addition to hosting the Migraine Again Podcast and producing the Migraine World Summit, Paula is a frequent speaker at industry, health care and public policy events. She's also the Founder and CEO of the World Health Education Foundation, a 501c3. Follow her on LinkedIn or Facebook.
Shah says that it’s harder to treat wrinkles with just Botox as they get more and more ingrained into the face. “Some people may need just a few injections, but some may require more treatments, such as laser treatments or a series of smaller procedures, which are going to cost more. Whereas if they came in five years earlier, I may have just been able to use Botox to get the same effect,” she says.
Marrying ophthalmology to dermatology, Jean and Alistair Carruthers observed that blepharospasm patients who received injections around the eyes and upper face also enjoyed diminished facial glabellar lines (“frown lines” between the eyebrows), thereby initiating the highly-popular cosmetic use of the toxin. Brin, and a group at Columbia University under Monte Keen made similar reports. In 2002, following clinical trials, the FDA approved Botox Cosmetic, botulinum A toxin to temporarily improve the appearance of moderate-to-severe glabellar lines. The FDA approved a fully in vitro assay for use in the stability and potency testing of Botox in response to increasing public concern that LD50 testing was required for each batch sold in the market.
BOTOX is administered about every three months, and must be injected at the site of each nerve trigger, relaxing the surrounding muscles so that they won’t compress the nerve and trigger a migraine. It is a potent drug, and we only recommend using it if other preventative treatment options haven’t helped you. It is generally only administered to patients who have at least 14 headaches a month, or don’t respond to other treatments.
Receiving Botox injections for migraines is a straightforward outpatient procedure. The skin in the area to be injected is cleaned. Most injections are administered in the forehead area, usually above the eyes or where “worry lines” might occur. Because this area may be sensitive or patients may be experiencing hypersensitivity to pain, a topical anesthetic may be applied before the injection.
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.
In both studies, significant improvements compared to placebo in the primary efficacy variable of change from baseline in wee kly frequency of incontinence episodes were observed for BOTOX (200 Units) at the primary efficacy time point at week 6. Increases in maximum cystometric capacity and reductions in maximum detrusor pressure during the first involuntary detrusor contraction we re also observed. These primary and secondary endpoints are shown in Tables 21 and 22, and Figures 7 and 8.
Think about it this way: people make facial expressions every single day, whether it's expressing an emotion (i.e. smiling) or simply out of habit (i.e. raising your brows). Making facial expressions causes temporary dynamic lines to show up in your face. These lines go away when your face returns to rest. However, as you continue to make facial expressions, day after day and year after year, and as your skin ages, these lines start to get etched in your skin. That's when frown lines get progressively deeper for people who frown all the time. Or when crow's feet stay put even after you stop smiling or squinting. Eventually, what once were dynamic wrinkles become wrinkles that are just there, even when you don't make any facial expressions.
If you think either of the FDA-approved anti-CGRP treatments might be right for you, speak with your primary health care provider, neurologist or headache specialist. If your medical provider isn’t aware of the treatments, don’t be afraid to let him or her know about them, or ask for a referral to a local neurologist or headache specialist. This is just the first step in advocating for the care that you deserve. To find a headache specialist in your area, consult our Find a Doctor tool. Dr. Starling believes that every person with migraine should be involved in advocacy, in order to bring awareness to the disease and break the stigma that surrounds it. She recommends that patients living with migraine get involved in advocacy organizations, such as our Move Against Migraine support community. You can also attend the annual Headache on the Hill event in which patients and providers go to Capitol Hill asking for more National Institutes of Health (NIH) research funding for migraine and other headache disorders. The next Headache on the Hill event is planned for February 11-12, 2019. Within the coming weeks, the American Migraine Foundation will be compiling a guide to all three anti-CGRP treatments. For additional information on anti-CGRP migraine treatment options, consult our doctor-verified resource library.
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. 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).