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Postmarketing safety data from BOTOX and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulti es can be life threatening and there have been reports of death related to spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, and partic ularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, symptoms consistent with spread of toxin effect have been reported at do ses comparable to or lower than doses used to treat cervical dystonia and spasticity. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders occur.
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.
Though botulinum toxin is available under different names, Botox is the only one that is FDA-approved for migraine prevention. To be considered for Botox, patients must have migraines 15 days or more per month, which is considered chronic daily migraine. About 4 million Americans have such migraines, according to the Migraine Research Foundation. Also, patients must have tried and failed on at least 2 other medications first.
That’s enough to generate buzz on the patient forums like RealSelf among those who have tried it: “My neck is killing me” wrote one user; I’ve got “Stiffness, pain in the neck, headache and can’t look down” reported another. Like anything, results vary widely. “I have since felt nauseous and dizzy on and off every day, as well as have blurry vision.
BOTOX may be an effective treatment for those who suffer from chronic migraines. Many patients have struggled to find a treatment that truly provides relief from this debilitating condition. While there are migraine medications and a host of natural remedies, for many people, none of these methods bring real relief. BOTOX may be the option that brings the relief from pain that patients have been seeking for so long.
OnabotulinumtoxinA is the only treatment approved by the United States Food and Drug Administration for the prevention of headaches in adult patients with chronic migraine (CM). CM assessment involves a detailed history to rule out secondary sources of headache, establish migraine features, and assess the total number of headache days. In order to diagnose migraine, the patient should have had at least five attacks that involve migraine features, as outlined below. In adults, untreated attacks usually last 4 or more hours.
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.
Exploratory analyses of this study suggested that the majority of patients who had shown a beneficial response by week 6 had returned to their baseline status by 3 months after treatment. Exploratory analyses of subsets by patient sex and age suggest that both sexes receive benefit, although female patients may receive somewhat greater amounts than male patients. There is a consistent trea tmentassociated effect between subsets greater than and less than age 65. There were too few non-Caucasian patients enrolled to draw any conclusions regarding relative efficacy in racial subsets.