The median duration of response in Study OAB-1 and OAB-2, based on patient qualification for re-treatment, was 19-24 weeks for the BOTOX 100 Unit dose group compared to 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.
In just over a decade, the number of people in the U.S. receiving cosmetic botulinum toxin type A injections--mostly from Botox but also from another brand called Dysport, which commands less than 10% of the market--exploded. From 2000 to 2015, use of the toxins for wrinkles increased 759%. It became a cultural phenomenon too, spawning Botox parties, Simpsons jokes, even greeting cards. In 2008, Sex and the City character Samantha famously quipped, "I don't really believe in marriage. Now Botox, on the other hand, that works every time."
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]

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]


Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e. g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from therapeutic doses of BOTOX [see Dysphagia And Breathing Difficulties].
Botox can be bought by essentially any person with a DEA certificate. Allergan sells it in 50 and 100 unit vials. They are shipped overnight delivery on dry ice to keep the toxin effective it should be opened, reconstituted and used the same day ideally. The Botox will work best this way. Price points will change by who the injector is and what their motives are. Botox can be reconstituted so that you getting a very dilute amount of product. So a by the area approach may really only give you a small amount of product. Or you could be getting old Botox that is a week old and will not last for very long.
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]
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Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).
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It may be necessary for the patient to have additional procedures, such as the use of filler substances (for example, Restylane, Perlane, Juvederm, Sculptra, or Radiesse) in order to plump up the wrinkles that are now relaxed. Additionally, it may be necessary to have two or three sessions of Botox treatment for deeper wrinkles before results become optimal. The area of the crease between the eyes is a particularly ideal area for Botox use in conjunction with filler as these fixed wrinkles don't always respond optimally to Botox alone. There is some controversy about using filler in that area as it may block veins or arteries and result in loss of blood and a scar to the area. Generally, the smaller particle fillers, such as Restylane or Juvederm Ultra, are best in the area between the eyes for this reason.
I had a consult and the doctor quickly realized that I was a candidate for Botox. He ordered an MRI and doppler of my brain to make sure everything else was A-OK, and then the rest was just waiting on my insurance company. With Botox (I’m not sure if it’s all Botox or just prescription), the insurance company orders it from a pharmacy and sends it to the doctor.
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).
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A placebo-controlled, double-blind post-approval 52 week study with BOTOX 100 Units (Study NDO-3) was conducted in non-catheterizing MS patients with urinary incontinence due to detrusor overactivity associated with a neurologic condition. Catheterization for urinary retention was initiated in 15.2% (10/66) of patients following treatment with BOTOX 100 Units versus 2.6% (2/78) on placebo at any time during the complete treatment cycle. The median duration of post-injection catheterization for those who developed urinary retention was 64 days for BOTOX 100 Units and 2 days for placebo.
Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).
The ideal needle to use is a 30G or 31G, half-inch needle. Longer needles are problematic as they encourage deeper injections, which can increase the risk of muscle weakness, and most of the side effects such as neck pain stem from muscle weakness. Perseverative-free normal saline is the only diluent that should be used. There is a case study of a patient who died when onabotulinumtoxinA was mixed with a local anesthetic agent. The pivotal trial established an effective dose using 2 mL/100 units of onabotulinumtoxinA. A fact that is often overlooked is that the mean dose in the trial was 165 units. The patients all received 155 units with a fixed dose, fixed-site injection protocol, and an option of an additional 40 units to follow the pain. This resulted in a mean dose of 165 units, which is the standard that should be used to achieve the efficacy results reviewed above.

There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

With the outbreak of World War II, weaponization of botulinum toxin was investigated at Fort Detrick in Maryland. Carl Lamanna and James Duff[42] developed the concentration and crystallization techniques that Edward J. Schantz used to create the first clinical product. When the Army’s Chemical Corps was disbanded, Schantz moved to the Food Research Institute in Wisconsin, where he manufactured toxin for experimental use and generously provided it to the academic community.
Other than that, there don’t seem to be any specific groups of people or health conditions that are contraindicated for Botox injections. As with all treatments, general health guidelines apply. People with a healthy body-mass index who are non-smokers, moderate or non-drinkers, and physically active will nearly always tolerate any type of medical treatment well.
Onabotulinumtoxin A (trade name Botox) received FDA approval for treatment of chronic migraines on October 15, 2010. The toxin is injected into the head and neck to treat these chronic headaches. Approval followed evidence presented to the agency from two studies funded by Allergan showing a very slight improvement in incidence of chronic migraines for migraine sufferers undergoing the Botox treatment.[86][87]

Proper refrigeration at temperatures below 3 °C (38 °F) retards the growth of Clostridium botulinum. The organism is also susceptible to high salt, high oxygen, and low pH levels.[citation needed] The toxin itself is rapidly destroyed by heat, such as in thorough cooking.[72] The spores that produce the toxin are heat-tolerant and will survive boiling water for an extended period of time.[73]

The recommended dilution is 200 Units/4 mL or 100 Units/2 mL with preservative -free 0.9% Sodium Chloride Injection, USP (see Table 1). The lowest recommended starting dose should be used, and no more than 50 Units p er site should generally be administered. An appropriately sized needle (e.g., 25-30 gauge) may be used for superficial muscles, and a longer 22 gauge needle may be used for deeper musculature. Localization of the involved muscles with techniques such as needle electromyographic guidance or nerve stimulation is recommended.

How does BOTOX work in migraines? The current theory is that BOTOX disrupts the trigeminal nerve terminal end. This leads to down-regulation of the trigeminal nerve cells and suppression of neurotransmitter release in two critical areas: central neuronal glutamate release and peripheral nerve inflammatory-inducing compounds such as CGRP in the cerebral blood vessels.
Spread of toxin effects.The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
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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