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 associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
The potency Units of BOTOX are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method [see DESCRIPTION].
BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
Hoffman’s husband’s experience is not unusual. Once a patient gets the more expensive prescription, health insurance providers can still try and push them back to cheaper drugs. Brigham and Women’s Hospital’s Loder says that most health insurance companies stop paying for Botox if it’s not reducing a patient’s migraines by at least 50 percent. “It’s important to keep careful headache diaries and keep careful notes in order to be able to prove to the insurance company that the treatment is worth it,” Loder says. “You’re not home free once they approve it.”
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.
The FDA approved such usage in the late 1980s when it was discovered that BOTOX® could stop ailments such as blepharospasm (uncontrolled blinking) and strabismus (lazy eye). Cosmetic physicians have been using BOTOX® for years to successfully treat wrinkles and facial creases. BOTOX® is approved for treatment of frown lines on the forehead, crow’s feet (lines around the eye), and axillary hyperhidrosis (increased sweating of the armpits). Within the past few years, new products that have similar preparations have been introduced into the U.S. market and have been well-received by patients.
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.”
Significant improvements compared to placebo in the primary efficacy variable of change from baseline in daily frequency of incontinence episodes were observed for BOTOX® (100 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 were also observed. These primary and secondary endpoints are shown in Table 23.
Unlike a face lift or other kind of invasive facial rejuvenation procedure, treatment takes minutes and requires zero downtime. Using a very fine needle, Botox is injected into the facial muscles that are responsible for unsightly wrinkles and fine lines and relaxes the muscles. The ingredients in Botox block the signal from the nerve to the muscle, and therefore reduce it’s ability to contract, and form unsightly wrinkles.
Duration of response was calculated as the number of days between injection and the date of the first visit at which patients returned to 3 or 4 on the HDSS scale. The median duration of response following the first treatment in BOTOX treated patients with either dose was 201 days. Among those who received a second BOTOX injection, the median duration of response was similar to that observed after the first treatment.
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.
The Company provides warranty programs for breast implant sales primarily in the United States, Europe and certain other countries. The United States programs include the ConfidencePlus program, which is limited to saline breast implants that provide lifetime product replacement and contralateral implant replacement. It also include ConfidencePlus Premier warranty programs, which are standard for silicone gel implants and require a low enrollment fee for saline breast implants, and generally provide lifetime product replacement along with financial assistance for both saline and silicone gel breast implants for surgical procedures within 10 years of implantation and contralateral implant replacement.
Focal Spasticity is a condition in which certain muscles in your body become stiff or tight. It is caused by damage to parts of the central nervous system that control voluntary movements. When this happens, your nerves send continuous messages to your muscles telling them to contract, or tighten. If you or someone you care for has stiffness in the muscles of the elbow, wrist, fingers, thumb, ankle, or toes, it could be Focal Spasticity.1