Recently, there have been concerns about retrograde botulinum toxin transmission, meaning that the toxin could travel back to the central nervous system, causing long-term damage. Studies done in Italy by Flavia Antonucci have been mainly on a raw form of the toxin and not any of the commercially available preparations. Additionally, these studies have been performed on animals and with the injection of the toxin to one area and in a concentration of nearly 150 times greater than normal injections for cosmetic indications, which are spread over multiple sites.
This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.
Key secondary endpoints included Physician Global Assessment, finger flexors muscle tone, and thumb flexors tone at Week 6. The Physician Global Assessment evaluated the response to treatment in terms of how the patient was doing in his/her life using a scale from -4 = very marked worsening to +4 = very marked improvement. Study 1 results on the primary endpoint and the key secondary endpoints are shown in Table 26.
Think about it this way: people make facial expressions every single day, whether it's expressing an emotion (i.e. smiling) or simply out of habit (i.e. raising your brows). Making facial expressions causes temporary dynamic lines to show up in your face. These lines go away when your face returns to rest. However, as you continue to make facial expressions, day after day and year after year, and as your skin ages, these lines start to get etched in your skin. That's when frown lines get progressively deeper for people who frown all the time. Or when crow's feet stay put even after you stop smiling or squinting. Eventually, what once were dynamic wrinkles become wrinkles that are just there, even when you don't make any facial expressions.
The most frequently reported adverse reactions following injection of BOTOX for adult lower limb spasticity appear in Table 17. Two hundred thirty one patients enrolled in a double-blind placebo controlled study (Study 6) received 300 Units to 400 Units of BOTOX, and were compared with 233 patients who received placebo. Patients were followed for an average of 91 days after injection.
In 1986, Scott's micromanufacturer and distributor of Botox was no longer able to supply the drug because of an inability to obtain product liability insurance. Patients became desperate, as supplies of Botox were gradually consumed, forcing him to abandon patients who would have been due for their next injection. For a period of four months, American blepharospasm patients had to arrange to have their injections performed by participating doctors at Canadian eye centers until the liability issues could be resolved.
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. 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.
“Botox is a completely cosmetic procedure, so if and when someone ‘needs’ it is a purely personal decision,” Shah says. “Some people are not bothered by developing fine lines and wrinkles. For those who are, I generally advise starting treatments just when they start to see the lines develop, or when the wrinkles linger even after the movement has stopped.”
So when I first propositioned my husband about the idea of me getting a bit of Botox for the furrowed brow I've earned from a decade of writing and editing behind a computer screen, he was adamantly against it. And frankly, I was a bit scared too. I mean, isn't Botox poison? As an idealistic 21 year old, it was easy to say that I'd never put that stuff in my body, that "poison." Now, I'm not so sure.
If going back for additional treatments three or four times a year sounds like a lot of treatments, the good news is that the more Botox treatments you get, the fewer Botox units you'll need. With each repeat Botox session, the frontalis muscle and other facial muscles surrounding Botox injection sites get a little weaker and become "trained" to not contract.
Once the protein stops functioning at the neuromuscular junction, it is broken down into its harmless components (amino acids) and either recycled for use in other proteins or excreted by the kidneys. "The bigger the muscle, the quicker you'll see motion return," says Rowe. "Likewise, the smaller the muscle, the longer the effect of botox lasts." It doesn't have a tolerance effect, either—your body never gets used to Botox.
Step therapy is largely unregulated both at the state and federal level, though individual states have started to pass legislation to limit step therapy and protect patients: 19 US states, including California, Mississippi, and Illinois, have laws that require insurance companies to grant certain exemptions or to review appeals from doctors within 72 hours so patients can get a waiver. But even then, getting a waiver isn’t always easy.
The migraines started later in life, before my lupus diagnosis. While sometimes they’d come out of the blue or I’d wake up with them, other times I’d see them coming. From a neurologist’s suggestion, I learned some of my “triggers” such as weather changes (specifically, drops in barometric pressure and incoming storms), hormonal changes and dairy. This past year I significantly reduced my dairy intake and although that didn’t eliminate the migraines, if I did eat dairy, I was sure to get one. Many of my migraines would also start as tension headaches. My neck is always extremely tight and eventually the constant tightness causes a migraine. Due to this, my old rheumatologist suggested taking a muscle relaxer at the beginning of a headache or before bed to keep my muscles from tensing up overnight and preventing a migraine. It worked sometimes… but definitely not enough.
According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA is administered to one site in the procerus muscle. The procerus injection site is approximately midway between the two corrugator injections. In order to confirm the location of the procerus muscle, the patient is asked to furrow the brow, which will activate the belly of the muscle causing the medial furrowing to occur. Once identified, 5 units of onabotulinumtoxinA is injected superficially into the belly of the muscle at a 90° angle to ensure the injection is administered into the procerus rather than the frontalis. Injections placed too superiorly may inadvertently lead to penetration of the frontalis muscle.
Botox costs can vary anywhere from $200 to $400 or more depending on the physician, location, units purchased, desired profit margin, ongoing promotions, etc. Many doctor's offices price Botox based on cost per unit, but others price Botox injections based on the area of the injection. Whether Botox is charged by the unit or by the area might not matter that much if the Botox treatment is effective, but if you want to know exactly how much you are paying for your treatment, you need to know the number of units of Botox per treatment and the cost per unit. (An honest practice will not hesitate to give you this information if you ask.)
Other treatment areas that have been proven to be useful include the scalp (for migraine headaches), neck, facial and peripheral muscles (for spasms), arm pits (to inhibit sweating), the bladder and numerous other areas. The way that Botox and Dysport work is that they temporarily inhibit muscle contraction beneath the skin. When underlying muscles are relaxed the overlying folds and wrinkles are smoothed out. These injections work only by weakening underlying muscle contraction are not facial fillers like Restylane or Juvederm. Fillers and Botox or Dysport injections are not interchangeable. These injections work only by weakening underlying muscle contraction are not facial fillers like Restylane or Juvederm. Fillers are not interchangeable with Botox or Dysport injections. Fillers replace or “fill-in” lost facial volume whereas Botox or Dysport only inhibit muscle contraction.Both treatments are in fact complimentary aesthetic injections that will relax wrinkles and folds and help you regain your youthful appearance and enhance your face.
In a double-blind, placebo-controlled, parallel group study in adult patients with detrusor overactivity associated with a neurologic condition and restrictive lung disease of neuromuscular etiology [defined as FVC 50-80% of predicted value in patients with spinal cord injury between C5 and C8, or MS] the event rate in change of Forced Vital Capacity ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 6).
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.
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 by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.