Botulinum toxin produced by Clostridium botulinum is the cause of botulism. Humans most commonly ingest the toxin from eating improperly-canned foods in which C. botulinum has grown. However, the toxin can also be introduced through an infected wound. In infants, the bacteria can sometimes grow in the intestines and produce botulinum toxin within the intestine and can cause a condition known as floppy baby syndrome. In all cases, the toxin can then spread, blocking nerves and muscle function. In severe cases, the toxin can block nerves controlling the respiratory system or heart, resulting in death. Botulism can be difficult to diagnose, as it may appear similar to diseases such as Guillain–Barré syndrome, myasthenia gravis, and stroke. Other tests, such as brain scan and spinal fluid examination, may help to rule out other causes. If the symptoms of botulism are diagnosed early, various treatments can be administered. In an effort to remove contaminated food which remains in the gut, enemas or induced vomiting may be used. For wound infections, infected material may be removed surgically. Botulinum antitoxin is available and may be used to prevent the worsening of symptoms, though it will not reverse existing nerve damage. In severe cases, mechanical respiration may be used to support patients suffering from respiratory failure. The nerve damage heals over time, generally over weeks to months. With proper treatment, the case fatality rate for botulinum poisoning can be greatly reduced.
Dr. Matarasso says hardly a week goes by when he doesn’t see a patient with a botched Botox job. Why? People are getting it done by unexperienced, often unlicensed, practitioners who don’t know the shape of the face and how to correctly administer the toxin. “I just had a patient come in the other day who went to an ER doctor, and one that went to a psychiatrist,” he says. “They [also] have these Botox parties and I have seen scarring, significant bruising, not only functional, but aesthetic complications.”
Currently, there are several anti-CGRP treatments undergoing clinical trials. Some of these treatments involve monoclonal antibodies, which reduce the activity of CGRP, potentially leading to fewer migraine attacks. One of these anti-CGRP monoclonal antibodies, erenumab (Aimovig™), has been approved by the Federal Drug Administration (FDA) and is now available for patients. A second agent, fremanezumab (Ajovy™), was approved in September 2018. A week later, the FDA approved galcanezumab (Emgality™), making it the third anti-CGRP treatment currently on the market. Results from the clinical trials involving anti-CGRP antibodies have shown that about 50 percent of patients will have at least a 50 percent reduction in migraine days. “If you think about someone who has 20 migraine days per month, they have a 50 percent chance of having 10 or less migraine days,” Dr. Starling says. “We think that there are even these super-responders who have a 75 percent response rate, as well as super-super-responders who actually go into remission.” The results from these clinical trials are very promising, Dr. Starling adds. “The adverse events have been very minimal and the efficacy has been very good. It’s all looking up.” Dr. Starling says that although these medications are available, what really needs to be looked at is how to make them truly accessible for patients. Erenumab can cost about $7,000 per year without insurance coverage. “Insurance coverage is very, very key for the majority of our patient population,” she says. “Because the medications just came out on the market, there are still a lot of unknowns about insurance coverage.”
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.
Last time I went in for my Botox treatment, my doctor asked me if I wanted to try Aimovig. Amgen and Novartis, the two manufacturers, were offering two free injections before I could access the drug through my health insurance. I declined. I didn’t want to start a new treatment that I’ll likely be booted from in a few months because of how expensive it is. Plus, the Botox is working great. I just wish I could have gotten it when I first went to see a migraine specialist, two and half years ago.
In double-blind, placebo-controlled chronic migraine efficacy trials (Study 1 and Study 2), the discontinuation rate was 12% in the BOTOX treated group and 10% in the placebo-treated group. Discontinuations due to an adverse event were 4% in the BOTOX group and 1% in the placebo group. The most frequent adverse events leading to discontinuation in the BOTOX group were neck pain, headache, worsening migraine, muscular weakness and eyelid ptosis.
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.
When moving a spastic limb through its range of motion, one feels a resistance to movement that increases with the speed at which one moves the limb. This is the definition of spasticity, but other terms such as increased muscle tone, hypertonicity, spastic dystonia, or flexor / extensor spasms are used to describe this resistance. In clinic the term "muscle spasticity" will be used to reduce confusion of terms.
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.
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.
Marrying ophthalmology to dermatology, Jean and Alistair Carruthers observed that blepharospasm patients who received injections around the eyes and upper face also enjoyed diminished facial glabellar lines (“frown lines” between the eyebrows), thereby initiating the highly-popular cosmetic use of the toxin. Brin, and a group at Columbia University under Monte Keen made similar reports. In 2002, following clinical trials, the FDA approved Botox Cosmetic, botulinum A toxin to temporarily improve the appearance of moderate-to-severe glabellar lines. The FDA approved a fully in vitro assay for use in the stability and potency testing of Botox in response to increasing public concern that LD50 testing was required for each batch sold in the market.
"The difference between using a cannula and a 'needle injection' technique is cannulas are a blunt tip needle that lets us place filler on a plane that allows it to last longer," explains Goodman. "They look better and preserve the 'untouched look' we're known for. Also, it's a more advanced technique that ensures the patient will not leave the office bruised."
When my babies were little, I never discussed migraine with them. As they grew into preschool and elementary age, I found it necessary to explain it to them. They had seen me experience migraine symptoms for a long time but understood it as just being sick. We went to a migraine walk where we talked about how others cope like I do, and they heard other stories that were similar to mine. They felt empowered that we had fundraised for a disease that affects millions and that we were fighting it as a family and community. My children want to help. Having ways they can help builds their confidence in their ability to take care of me, as I do them. They know to turn the lights off, get ice and talk quietly. I have taught them how to be self-sufficient. I’m so proud of how they take care of themselves and are willing to take care of others. The qualities that they’re learning and displaying will carry them through life.
BOTOX injections for migraines is a preventative treatment, rather than treating the condition with pain medication. It was FDA-approved in 2010 and is considered an appropriate treatment for adults who experience migraine headaches more than 15 days per month, for more than three months. The product blocks the release of certain brain chemicals, and it is believed that blocking these chemicals limits the nerve signals causing pain.
Side effects from cosmetic use generally result from unintended paralysis of facial muscles. These include partial facial paralysis, muscle weakness, and trouble swallowing. Side effects are not limited to direct paralysis however, and can also include headaches, flu-like symptoms, and allergic reactions. Just as cosmetic treatments only last a number of months, paralysis side-effects can have the same durations. At least in some cases, these effects are reported to dissipate in the weeks after treatment. Bruising at the site of injection is not a side effect of the toxin but rather of the mode of administration, and is reported as preventable if the clinician applies pressure to the injection site; when it occurs, it is reported in specific cases to last 7–11 days. When injecting the masseter muscle of the jaw, loss of muscle function can result in a loss or reduction of power to chew solid foods.
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, which was later purified by P Tessmer Snipe and Hermann Sommer.
Risks are very minor with this procedure. The main risks consist of headache, pain, and flu-like illness. In rare cases, there may be a drooping lid or eyebrow area. It is important for the cosmetic surgeon to assess the patient's lids before injecting because the patient may not be a good candidate if he or she has an extremely droopy lid to begin with or one that is held up by constantly arching the lids. Ptosis (a severe drooping of the eyelid) can occur in up to 5% of patients but is very rare if the cosmetic surgeon does this procedure often. These complications are typically very minor occurrences and resolve with time.
"The cost for a procedure depends on two main factors," explains Joshua Zeichner, MD, a board-certified dermatologist. "First, different products cost different amounts because of the technology that goes into their manufacturing. In addition, the cost depends on the fee of the injector. If you are seeing a sought-after, skilled injector, you may be paying a premium for that treatment. Especially when getting injectable fillers, your treatment is dependent on the skill and aesthetic of your injector. I do not recommend compromising here or purchasing a deal on websites like Groupon."
The median duration of response in study NDO-3, based on patient qualification for re-treatment was 362 days (52 weeks) for the BOTOX 100 Units dose group compared to 88 days (13 weeks) for placebo. To qualify for re-treatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least 2 urinary incontinence episodes over 3 days with no more than 1 incontinence -free day.
Now, thanks in large part to off-label use, Botox--the wrinkle smoother that exploded as a cultural phenomenon and medical triumph--is increasingly being drafted for problems that go far beyond the cosmetic. The depression suffered by Rosenthal's patient is just one example on a list that includes everything from excessive sweating and neck spasms to leaky bladders, premature ejaculation, migraines, cold hands and even the dangerous cardiac condition of atrial fibrillation after heart surgery, among others. The range of conditions for which doctors are now using Botox is dizzying, reflecting the drug's unique characteristics as much as the drug industry's unique strategies for creating a blockbuster.
Botox is injected in and around the head on an average of every three months. It blocks signals from nerves and paralyzes the muscles, ultimately preventing migraines. It is known to relax the muscles that usually contract during migraines. It’s also the only FDA-approved medication to prevent migraines before they even start! It’s known to prevent about nine migraines per month.
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Extraocular muscles adjacent to the injection site can be affected, causing vertical deviation, especially with higher do ses of BOTOX. The incidence rates of these adverse effects in 2058 adults who received a total of 3650 injections for horizontal strabismus was 17%. The incidence of ptosis has been reported to be dependent on the location of the injected muscles, 1% after inferior rectus injections, 16% after horizontal rectus injections and 38% after superior rectus injections.
How Was the Botox Mixed? A factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
Both Aetna and HealthPartners tell The Verge in an email that they don’t require patients to try verapamil specifically. “Verapamil is just one of many options available to treat migraines. Some are FDA-approved, others are not,” says Becca Johnson, a spokesperson for HealthPartners. Patients are required to try other oral medications because they’re either cheaper or not as invasive as getting Botox injections. “The rationale is that these medications are generally effective and safe,” says Ethan Slavin, a spokesperson for Aetna.
One glaring example took place over the weekend, when someone on Twitter (TWTR) posted a photograph of an injured police officer, with a caption that he’d been “brutalized” by the migrant caravan on its way to the United States. “These pictures do not capture police officers who were brutalized by members of the immigrant caravan making its way toward the U.S. in October 2018,” Snopes explained.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
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).