There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women. In animal studies, administration of BOTOX during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see Data)].
After an exam by a therapist and doctor, botulinum toxin for focal relief of muscle spasticity can be advised as the best way to address a child's functional problems. The problem muscle groups are identified, and goals for that child are discussed. Then the injection of botulinum toxin can be done if there are no permanent contractures of the muscle groups.
"Neurotoxins and facial fillers are my most popular injectable treatments," notes Zeichner. "Neurotoxins like Botox and Dysport relax muscles under the skin that can lead to folding and lines, specifically frown lines between the eyebrows. Facial fillers are my favorite cosmetic procedure in the office—there's really an art to it. I exclusively use hyaluronic acid fillers because they are safe and long-lasting."
Fine lines, frown lines, how-did-those-get-there lines. Whatever you call them, a few minutes of Botox can smooth wrinkles on your forehead, in-between your eyes, and crow’s feet. This is a non-invasive FDA-approved treatment that requires zero downtime, so you can come in and erase those signs of aging on your lunch break. Using a very fine needle we inject Botox intothe facial muscles responsible for those annoying wrinkles, totally relaxing them and reducing their ability to contract. Don’t worry, you’ll be out the door and on your way to feeling refreshed and radiating confidence in no time.
With abnormal joint movement and inactivity, muscles can shorten and contract. In the case of muscle spasticity, the joint and soft tissue can be normal, but with constant contraction of a muscle because of spasticity the muscle can shorten. When it can no longer stretch to allow full range of motion, a contracture can happen. Agents that lessen the spasticity of the involved muscles best prevent this type of contracture.
"As we get older, we lose volume in our face and hyaluronic acid filler can be used as a replacement,” explains Wexler. "For younger women, injections can be used to treat areas with acne scarring or hollowness under the eyes." During your ‘20s, when the face is at its fullest and healthiest, it has been argued that a shadowy gaze can even be quite charming. But in other cases, hereditary dark circles can result in a persistently tired look, which is where a few drops of filler under the eyes may be useful. As top dermatologist David Colbert, M.D. is quick to note, however, too much Botox and filler distorts the face and as a result will make you appear older. “When the line is crossed everyone starts looking like they are related," he also cautions of a uniform cookie-cutter appearance that lacks character or individuality. Or worse. “It’s a snowball effect of people liking something, coming back too soon [for even more], and then it gets too heavy,” adds Wexler.
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.
During treatment, very low doses of Botox® Cosmetic are administered via a few tiny injections directly into the muscles responsible for frown lines between the brows. By blocking the release of a chemical that causes them to contract, Botox® Cosmetic enables them to relax. The effects are very localized and, when administered by an experienced injector, do not affect your ability to smile, laugh, or otherwise show expression. Botox® Cosmetic is the only product of its kind that has been approved for use in this area.
In two double-blind, placebo-controlled trials in patients with detrusor overactivity associated with a neurologic condition (NDO-1 and NDO-2), the proportion of subjects who were not using clean intermittent catheterization (CIC) prior to inject ion and who subsequently required catheterization for urinary retention following treatment with BOTOX 200 Units or placebo is shown in Table 9. The duration of post-injection catheterization for those who developed urinary retention is also shown.
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.
Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscle for the treatment of cervical dystonia have been reported to be at greater risk for dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Injections into the levator scapulae may be associated wit h an increased risk of upper respiratory infection and dysphagia.
The drug has come a long way since its ability to smooth facial wrinkles was first discovered, by accident. In the 1970s, ophthalmologist Dr. Alan B. Scott started studying the toxin as a therapy for people with a medical condition that rendered them cross-eyed. "Some of these patients that would come would kind of joke and say, 'Oh, Doctor, I've come to get the lines out.' And I would laugh, but I really wasn't tuned in to the practical, and valuable, aspect of that," Scott told CBS in 2012. Scott named the drug Oculinum and formed a company of the same name in 1978. In 1989 he received FDA approval for the treatment of strabismus (the crossed-eye disorder) and abnormal eyelid spasms.
Botulinum toxin has been investigated for use in patients with blepharospasm in several studies. In an open label, historical ly controlled study, 27 patients with essential blepharospasm were injected with 2 Units of BOTOX at each of six sites on each side. Twenty-five of the 27 patients treated with botulinum toxin reported improvement within 48 hours. One patient was controlled with a higher dosage at 13 weeks post initial injection and one patient reported mild improvement but remained functionally impaired.
Still, there have been enough concerns that the FDA instituted a REMS (Risk Evaluation and Mitigation Strategy) requirement for all botulinum toxin preparations that specifically addresses the issues of distant spread of the toxin and the risk of problems, leading to death, from swallowing or breathing issues in certain patients who may be susceptible after botulinum toxin treatment. All products, including Dysport, Myobloc, Xeomin, and Botox, are monitored via this strategy. This is specifically aimed at a certain population of patients receiving more than the usual doses of botulinum toxin and not aimed at the casual user of Botox, per se.
I was lucky. My health insurance only required me to try and fail two other less expensive migraine medications, and it didn’t dictate how long I had to try them for before giving up. Other insurers have stricter rules: Aetna, for example, requires patients to try at least three medications for at least two months each. HealthPartners also requires patients to try and fail three medications, such as beta blockers and antidepressants, without specifying for how long. (Requirements may vary by state and policy.) Because these migraine drugs are designed to treat other conditions like high blood pressure and depression, they can have serious side effects like weight gain, fatigue, and difficulty in thinking and speaking clearly.
Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist f or several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
So what exactly are you putting into your face? John Paul Tutela, MD, a board certified plastic surgeon, explains, “Botox is a cosmetic injectable neurotoxin that is a very diluted form of Botulinum Toxin, which is found in the bacteria Clostridium botulinum. In this diluted format, it is used to relax your muscles—typically in your forehead, in between your eyebrows, and around your eyes.” The idea is that if you temporarily block local nerve impulses to specific muscles within your face, you won’t make certain facial expressions, so you won’t form the wrinkles that come with them, explains dermatologist Tsippora Shainhouse, MD, FAAD. These are the 7 signs you’re ready for Botox? (And 6 signs you aren’t.)
Allergan Plc engages in the research, development, and manufacture of pharmaceutical products. It operates through the following business segments: US Specialized Therapeutics; US General Medicine, and International. The US Specialized Therapeutics segment includes sales and expenses relating to branded products within the United States. The US General Medicine segment involves Central Nervous System; Gastrointestinal; Women's Health; Anti-Infectives; and Diversified brands. The International segment comprises of products sold outside the United States. The company was founded on in 1984 and is headquartered in Dublin, Ireland.
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 post-injection 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).