Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These 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 difficulties can be life threatening and there have been reports of death. 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, particularly 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, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
Botox gained popularity and notoriety as a wrinkle reducer in the late 1990s and early 2000s. But it wasn’t long before researchers recognized the potential of Botox for treating medical conditions, too. Today it’s used to treat problems such as repetitive neck spasms, eye twitching, and overactive bladder. In 2010, the FDA approved Botox as a preventive treatment option for chronic migraines.
The 3rd Annual Migraine Moment Film Contest received a record-breaking number of film submissions this year. Each film delivered a unique message on living with migraine and how people cope with the symptoms that accompany this debilitating disease. At the 60th Annual Scientific Meeting in San Francisco earlier this year, Maria Galli was announced as the contest’s winner. Her powerful film, Invisible Hero, spoke to her strength and superhero-like qualities in fighting a disease that oftentimes makes her feel isolated and alone. In a recent Facebook Live hosted by the American Foundation, Maria Galli spoke with Dr. Bert Vargas, a Neurologist at UT Southwestern, about her experience living with chronic migraine and her outstanding work. [embed]https://www.facebook.com/americanmigrainefoundation/videos/1616373701807260/[/embed]
Allergan plc, incorporated on May 16, 2013, is a specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of brand name pharmaceutical products, medical aesthetics, biosimilar and over-the-counter (OTC) pharmaceutical products. The Company operates through three segments: US Specialized Therapeutics, US General Medicine and International. The US Specialized Therapeutics segment includes sales relating to branded products within the United States, including Medical Aesthetics, Medical Dermatology, Eye Care, Neurosciences and Urology therapeutic products. The US General Medicine segment includes sales relating to branded products within the United States that do not fall into the US Specialized Therapeutics business units, including Central Nervous System, Gastrointestinal, Women's Health, Anti-Infectives and Diversified Brands. The International segment includes sales relating to products sold outside the United States. Within its US Specialized Therapeutics, US General Medicine and International operations, the Company sells its brand and aesthetic pharmaceutical products primarily to drug wholesalers, retailers and distributors, including national retail drug and food store chains, hospitals, clinics, mail-order retailers, government agencies and managed healthcare providers, such as health maintenance organizations and other institutions.
Safety and effectiveness of BOTOX® have not been established for the treatment of other upper or lower limb muscle groups or 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.
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.
Over the next three decades, 1895-1925, as food canning was approaching a billion-dollar-a-year industry, botulism was becoming a public health hazard. Karl Friedrich Meyer, a prodigiously productive Swiss-American veterinary scientist created a center at the Hooper Foundation in San Francisco, where he developed techniques for growing the organism and extracting the toxin, and conversely, for preventing organism growth and toxin production, and inactivating the toxin by heating. The California canning industry was thereby preserved.
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In addition to glabellar lines, Botox is used to eradicate crow’s feet, frown lines, and lines and furrows in the forehead. Whereas treating crow's feet and forehead lines with Botox was for many years an off-label use, the toxin has since received FDA approval for both uses. Botox is also approved to treat a variety of medical conditions, including ocular muscle spasms, problems with eye coordination, severe armpit perspiration, migraine headaches, overactive bladder, urinary incontinence related to nerve damage from conditions such as multiple sclerosis and spine injury. Botox is being studied to determine if it might be useful in treating conditions such as knee and hip osteoarthritis, temporomandibular joint disorder (TMJ) and benign prostatic hyperplasia (BPH).
The most common severe adverse reaction associated with the use of BOTOX injection in patients with cervical dystonia is dysp hagia with about 20% of these cases also reporting dyspnea [see WARNINGS AND PRECAUTIONS]. Most dysphagia is reported as mild or moderate in severity. However, it may be associated with more severe signs and symptoms [see WARNINGS AND PRECAUTIONS].
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.