Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingest ion occur or overdose be suspected, the person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local, or distant from the site of injection [see BOX WARNING and WARNINGS AND PRECAUTIONS]. These patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalization.
The number of headache days determines whether the patient has episodic migraine (EM) (14 or fewer headache days a month) or CM (more than 15 days of headache a month). The best method of determining the actual number of headache days is to subtract this from the number of completely headache-free days in a month. If headache is present on more than half the days in the month, and there are migraine features on at least 8 days a month, the condition is termed CM. The migraine features only have to be present on 8 days out of the month and not on every headache day. The other headache days in this condition are considered to be milder forms of migraine, and they do not have all the typical migraine features. If headache is present on fewer than 15 days a month, this is referred to as EM. EM can transform to CM over time. If analgesics are used on 10 or more days per month, this can lead to a transformation to CM. The patient’s headache pattern over a 12-month period should be determined, and during this time, there should be at least 3 months with 15 headache days; 8 of these days should meet migraine criteria.1-3
Khalaf Bushara and David Park were the first to demonstrate a nonmuscular use of BTX-A while treating patients with hemifacial spasm in England in 1993, showing that botulinum toxin injections inhibit sweating, and so are useful in treating hyperhidrosis (excessive sweating). BTX-A has since been approved for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating of unknown cause), which cannot be managed by topical agents.
The following adverse reactions with BOTOX 200 Units were reported at any time following initial injection and prior to re -injection or study exit (median duration of exposure was 44 weeks): urinary tract infections (49%), urinary retention (17%), constipation (4%), muscular weakness (4%), dysuria (4%), fall (3%), gait disturbance (3%), and muscle spasm (2%).
The trapezius muscle is a large, triangular, superficial muscle. It attaches proximally in the medial third of the superior nuchal line, external occipital protuberance, nuchal ligament, and spinous processes of the C7-T12 vertebrae. Distal attachment of the trapezius occurs at the lateral third of the clavicle and acromion and spine of the scapula. The action of the muscle includes neck extension and stabilization of the scapula and support for the arm. The muscle fibers proximal to the inflection point of the neck (ie, necklace line) run vertically and are involved with neck extension. According to the PREEMPT injection paradigm, one injection of 5 units of onabotulinumtoxinA to each of three sites on either side of the trapezius, for a total of 30 units divided across six sites, is given. The first injection site can be identified by visually dividing the upper portion of the trapezius muscle in half, from the inflection point of the neck (ie the necklace line) to the acromion (acromio-clavicular joint); the midpoint of this location is where the injection should be administered. The second injection is located at the midpoint of the first injection site and the acromion. The third injection should be administered at the midpoint between the first injection site and the necklace line. Injections should occur in the supraclavicular portion of the muscle, lateral to the neckline, and medial to the deltoid and the acromio-clavicular joint. The injections into the trapezius should be administered horizontally and superficially to avoid injecting too deep.
Side effects from therapeutic use can be much more varied depending on the location of injection and the dose of toxin injected. In general, side effects from therapeutic use can be more serious than those that arise during cosmetic use. These can arise from paralysis of critical muscle groups and can include arrhythmia, heart attack, and in some cases seizures, respiratory arrest, and death. Additionally, side effects which are common in cosmetic use are also common in therapeutic use, including trouble swallowing, muscle weakness, allergic reactions, and flu-like syndromes.
It’s not just about Botox, though. Last month, the FDA approved the first migraine-specific drug to prevent the severe headaches. Called Aimovig, the injectable med will cost $6,900 a year, according to The New York Times, plus injection fees. Because of the high costs, experts expect the new drug to be subject to step therapy policies. Stephen Silberstein, the director of the headache center at Jefferson University, told me in 2016 that he wouldn’t be surprised if insurance companies required patients to even try and fail Botox before covering the new meds (there are a few of them under development).
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.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.