Safety and effectiveness of BOTOX have not been established for the treatment of other upper or lower limb muscle groups. Safety and effectiveness of BOTOX have not been established 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.
It can also be expensive. Depending on your insurance, it can cost quite a lot of money — I've changed insurance providers since I first started, and my first provider was around $330 a month and charged me around $1,000 per Botox round (remember, that's four times a year). My new plan is much more expensive, around $600 a month, but the Botox copay is only $30 each time, so even if Botox is the only medical procedure I need to have done in the year, it made sense to switch.

Botox was introduced to the world in the late 1980s by ophthalmologists, who began using it to treat optic muscle disorders. It was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines) in 2002, and its popularity has soared ever since. Botox is consistently one of the top five nonsurgical cosmetic procedures performed each year.


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In some cases known as off-label use, doctors are safely administering it for conditions other than what it is officially approved for, including prostate issues, and eye-crossing (known medically as strabismus) cerebral palsy—which had my jaw on the floor. Rowe even went on to tell me it's the drug of the twenty-first century. "It's like Tylenol or aspirin," he marveled to SELF. "It's what penicillin was in the mid-twentieth century."
There are no data on the presence of BOTOX in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BOTOX and any potential adverse effects on the breastfed infant from BOTOX or from the underlying maternal conditions.

The needle should be inserted approximately 2 mm into the detrusor, and 30 injections of 1 mL (~6.7 Units) each (total volume of 30 mL) should be spaced approximately 1 cm apart (see Figure 1). For the final injection, approximately 1 mL of sterile normal s aline should be injected so that the remaining BOTOX in the needle is delivered to the bladder. After the injections are given, the saline used for bladder wall visualization should be drained. The patient should be observed for at least 30 minutes post -injection.
Galli has been living with migraine for most of her adult life, but recently, her attacks became more severe and frequent. “My whole life went upside down and nothing was the same,” Galli says, upon being diagnosed with chronic migraine. “The person I used to be wasn't there anymore. I didn't even recognize myself.” To cope with the symptoms that often accompany chronic migraine, Galli found herself retreating to a dark room, waiting for the pain to pass, but it never did. In response, Galli says, she asked herself what she could do to feel better but also share her story. “Everyone around me that knew how high energy, and how much of a go-getter I am, asked what was happening? Where was that person?” When she came across the announcement of the Migraine Moment Film Contest, she saw it as her opportunity to bring awareness about what it is like to live with migraine and bust the misconceptions surrounding this invisible disease. Enter: “Invisible Hero.”

After working out techniques for freeze-drying, buffering with albumin, and assuring sterility, potency, and safety, Scott applied to the FDA for investigational drug use, and began manufacturing botulinum type A neurotoxin in his San Francisco lab. He injected the first strabismus patients in 1977, reported its clinical utility in 1980,[47] and had soon trained hundreds of ophthalmologists in EMG-guided injection of the drug he named Oculinum ("eye aligner").


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.
In 2005, the national average cost of a BOTOX® injection was just over $375. However, the cost of BOTOX® treatment varies from area to area. In 2005, the northeastern United States had the highest BOTOX® average cost, at just over $500, while the western states had the lowest average, at under $370. It is important to keep in mind that these statistics may be somewhat misleading, as the cost of BOTOX® injections in Los Angeles will almost certainly be higher than BOTOX® treatment price in say, a rural area of Pennsylvania.
Just because not every cosmetic Botox procedure is FDA-approved doesn't mean it's not safe and effective, if done properly. Off-label procedures are still within the standard of care, and there are tons of them. “There are so many non-FDA-approved applications for Botox,” says dermatologist Dendy Engelman, MD. “It can be used to decrease scalp-sweating (which helps prolong blowouts), correct a droopy nasal tip (called nasal-tip ptosis), fix brow asymmetry, minimize bunny lines from wrinkling your nose, decrease skin oiliness, minimize the appearance of pores...” The list goes on and on.
Botox must be used only under a doctor's care. It's important that injections be placed precisely in order to avoid side effects. Botox therapy can be dangerous if it's administered incorrectly. Ask for a referral from your primary care doctor or look for a doctor who specializes in your condition and who has experience in administering Botox treatments.
Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.

Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.


BOTOX was evaluated in two randomized, multi-center, 24-week, 2 injection cycle, placebo-controlled double-blind studies. Study 1 and Study 2 included chronic migraine adults who were not using any concurrent headache prophylaxis, and during a 28 -day baseline period had ≥15 headache days lasting 4 hours or more, with ≥50% being migraine/probable migraine. In both studies, patients were randomized to receive placebo or 155 Units to 195 Units BOTOX injections every 12 weeks for the 2-cycle, double-blind phase. Patients were allowed to use acute headache treatments during the study. BOTOX treatment demonstrated statistically significa nt and clinically meaningful improvements from baseline compared to placebo for key efficacy variables (see Table 24).


Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.


Still, Botox's use for depression raises a question that confounds some researchers. In some cases, how Botox works is evident: the toxin can block the signals between nerves and muscles, which is why it can help calm an overactive bladder, say, or a twitching eye, or the facial muscles that make wrinkles more apparent. In other cases, however (with migraines as well as with depression), scientists are flummoxed. They may have noticed that the drug works for a given condition, but they aren't always sure why--in sciencespeak, they don't know what the mechanism is.
In 1895 (seventy-five years later), Émile van Ermengem, professor of bacteriology and a student of Robert Koch, correctly described Clostridium botulinum as the bacterial source of the toxin. Thirty-four attendees at a funeral were poisoned by eating partially salted ham, an extract of which was found to cause botulism-like paralysis in laboratory animals. Van Ermengem isolated and grew the bacterium, and described its toxin,[40] which was later purified by P Tessmer Snipe and Hermann Sommer.[41]
BOTOX is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) , finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus).
Aesthetician Mary Schook is anti-Botox because she sees the long-term effects on her clients. “Everyone is always like, ‘Look how great this looks,’ and then there is the long-term and they are like, 'Fix me,'” she says. “Allergan [the company that owns Botox] says one in 100 patients gets eyelid-drop, so I always joke, ‘I must meet one in 100 patients, because everyone I see has that drop.'”
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It was peculiar advice coming from a shrink, but not without precedent. In 2014, Rosenthal, a clinical professor of psychiatry at Georgetown University School of Medicine, and Dr. Eric Finzi, an assistant professor of psychiatry at George Washington School of Medicine, published a study showing that when people with major depression got Botox, they reported fewer symptoms six weeks later than people who had been given placebo injections. "I'm always on the lookout for things that are unusual and interesting for depression," says Rosenthal, who is widely considered an expert on the condition. "I've found Botox to be helpful, but it's still not mainstream."
With regard to detection, current protocols using NBC detection equipment (such as M-8 paper or the ICAM) will not indicate a "positive" when samples containing botulinum toxin are tested.[citation needed] To confirm a diagnosis of botulinum toxin poisoning, therapeutically or to provide evidence in death investigations, botulinum toxin may be quantitated by immunoassay of human biological fluids; serum levels of 12–24 mouse LD50 units per milliliter have been detected in poisoned patients.[63]
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.

* LS mean change, treatment difference and p-value are based on an analysis using an ANCOVA model with baseline weekly endpoint as covariate and treatment group, etiology at study entry (spinal cord injury or multiple sclerosis), concurrent anticholinergic therapy at screening, and investigator as factors. LOCF values were used to analyze the primary efficacy variable.
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.
In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.
Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure.
The biological blocking powers of Botox are used to treat migraines, muscular disorders, and some and bowel disorders. It can treat muscle stiffness, muscle spasms, overactive bladder, or loss of bladder control, too. It's also used to stop excessive sweating. "Botox blocks glands the same way it blocks nerves in muscles," Sobel tells SELF. However, don't expect to stop sweating entirely, he says. "You've got to sweat somewhere." What's more, Botox will last far longer in these sweaty situations since the glands are far smaller than the muscles treated, says Rowe.

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.

That said, there are a few things I'd make sure everyone knows before trying it. For one thing, it can be pretty painful. I have a pretty high pain tolerance, but getting 30 to 40 shots every three months is pretty rough — it feels a bit like getting tattooed with a bee's stinger, but once the needle is out of your skin, the pain goes away, and if it works for you, it's worth it. It's also important to know that it can take some time to work. The first treatment barely worked at all for me, and the second round took a few weeks. If you're going to try it out, be patient.

Younger patients have been increasingly hopping on the Botox bandwagon as a preventative measure—even before the wrinkles appear or deepen. That’s why dermatologists can’t recommend the best age to start or try Botox, since it depends on your goals, your facial expressions, and your preference. If all you see when you look at a photo of yourself is that forehead wrinkle instead of your bright eyes or smile, it might make you happier to get the wrinkle taken care of. “Each time we raise our eyebrows, or scowl by bringing our eyebrows together, the wrinkles in these locations get deeper and more numerous. It happens slowly over a long period of time, so you don’t notice it on a daily basis,” Dr. Tutela says. “But if you look at the horizontal wrinkles in your forehead when you are not raising your eyebrows, you will see an increase in these wrinkles when you do raise your brows. If you then hold that raised brow position for 10 seconds, you will notice when you relax, your forehead wrinkles look deeper and more numerous. Botox prevents this from happening.” It’s almost never too early to start a good anti-aging regimen. Learn the most in-demand cosmetic treatments across the US.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
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