In detrusor overactivity associated with neurologic condition patients with analyzed specimens in the drug development program (including the open-label extension study), neutralizing antibodies developed in 3 of 300 patients (1.0%) after receiving only BOTOX 200 Unit doses and 5 of 258 patients (1.9%) after receiving at least one 300 Unit dose. Following development of neutralizing antibodies in these 8 patients, 4 continued to experience clinical benefit, 2 did not experience clinical benefit, and the effect on the response to BOTOX in the remaining 2 patients is not known.
Botulinum toxin exerts its effect by cleaving key proteins required for nerve activation. First, the toxin binds specifically to nerves which use the neurotransmitter acetylcholine. Once bound to the nerve terminal, the neuron takes up the toxin into a vesicle. As the vesicle moves farther into the cell, it acidifies, activating a portion of the toxin which triggers it to push across the vesicle membrane and into the cell cytoplasm.[1] Once inside the cytoplasm, the toxin cleaves SNARE proteins preventing the cell from releasing vesicles of neurotransmitter. This stops nerve signaling, leading to paralysis.[1]
Botox should only be injected with sterile instruments in a doctor's office or a medical spa — not at Botox parties at your local nail salon or neighbor's living room. Botox injection is usually performed with some local anesthesia or a numbing cream. You may feel some minimal discomfort from the shot, but today's needles are so thin and fine that the procedure is often painless. Depending on the extent of treatment, the procedure can take anywhere from a few minutes to 20 minutes.
It's a remarkable arc for a drug that only a few years ago was associated with Hollywood cocktail parties where guests came for Bellinis and left with a forehead full of Botox injections. It highlights the advances that can occur when physicians, seeking new therapies for their patients, explore creative new uses for approved drugs--basically, real-world experiments that take place largely beyond the reach of federal regulators. That, in turn, raises questions about the risks of deploying medicines in ways that have not been fully vetted. But it happens all the time.
Botox should definitely last longer than a few weeks, but how much longer varies. First time Botox users, for example, might experience Botox wearing off in less than 3 months. However, as facial muscles get conditioned to Botox, results should lengthen. Botox injections around the eyes can also last shorter than 3 months. Men, on the other hand, tend to need more Botox than women. Whatever the case, Botox results should generally last around 3 months, give or take a few days.
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.”
The cosmetic effect of BTX-A on wrinkles was originally documented by a plastic surgeon from Sacramento, California, Richard Clark, and published in the journal Plastic and Reconstructive Surgery in 1989.[51] Canadian husband and wife ophthalmologist and dermatologist physicians, JD and JA Carruthers, were the first to publish a study on BTX-A for the treatment of glabellar frown lines in 1992.[52] Similar effects had reportedly been observed by a number of independent groups (Brin, and the Columbia University group under Monte Keen.[53]) After formal trials, on April 12, 2002, the FDA announced regulatory approval of botulinum toxin type A (Botox Cosmetic) to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines).[54] Subsequently, cosmetic use of botulinum toxin type A has become widespread.[78] The results of Botox Cosmetic can last up to four months and may vary with each patient.[79] The US Food and Drug Administration approved an alternative product-safety testing method in response to increasing public concern that LD50 testing was required for each batch sold in the market.[55][56]
In 1950, pharmacist Gavin S. Herbert established Allergan Pharmaceuticals, Inc. Allergan focused on the discovery and development of novel formulations for specialty markets, as well as intimate collaboration with physicians and the scientific community. In 1953, Allergan produced eye drops and formulated new products such as the first cortisone eye drop to treat allergic inflammation and the first ophthalmic steroid decongestant.
Botox (also known as Vistabel outside the U.S. and the U.K.) is an injection that temporarily relaxes facial muscles to reduce the appearance of fine lines and wrinkles, as well as prevent new lines from forming. Common injection sites include the forehead, the area between the eyebrows, the corners of the eyes, and the sides of the chin. Botox can also be used for a wide variety of other conditions, including migraines, excessive sweating, and psoriasis. LEARN MORE ›
In the case of Botox, doctors who experiment off-label say they do so because they're looking for better treatment options for their patients. "In my 30 years of medical practice, Botox is one of the most impactful treatments I had ever seen," says Dr. Linda Brubaker, dean and chief diversity officer of the Loyola University Chicago Stritch School of Medicine, who independently studied Botox for overactive bladder before the FDA approved it for that condition in 2013.

Temporary bruising is the most common side effect of Botox. Headaches, which resolve in 24-48 hours, can occur, but this is rare. A small percentage of patients may develop eyelid drooping. This usually resolves in three weeks. This usually happens when the Botox moves around so you shouldn't rub the treated area for 12 hours after injection or lay down for three to four hours.


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.
Botox® neurotoxin treatment helps control the symptoms of severe underarm sweating when topical medicines do not work well enough by temporarily blocking the chemical signals from the nerves that stimulate the sweat glands. When the sweat glands don’t receive chemical signals, the severe sweating stops. Botox® injections are expected to temporarily stop the production of excessive sweat in the treated areas only. Sweat continues to be produced elsewhere.
In the case of Botox, doctors who experiment off-label say they do so because they're looking for better treatment options for their patients. "In my 30 years of medical practice, Botox is one of the most impactful treatments I had ever seen," says Dr. Linda Brubaker, dean and chief diversity officer of the Loyola University Chicago Stritch School of Medicine, who independently studied Botox for overactive bladder before the FDA approved it for that condition in 2013.
BOTOX® treats the symptoms of severe underarm sweating when topical medicines do not work well enough in people 18 years and older. It is not known whether BOTOX® is safe or effective for severe sweating anywhere other than your armpits. BOTOX® treatments temporarily block the chemical signals from the nerves that stimulate the sweat glands, resulting in reduced sweating.
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