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.
The results usually start to be noticed within three to 10 days or even sooner. They tend to last in most people for up to three or four months. As time passes, the muscle activity will gradually return to normal. Additionally, other areas may return to activity over time, depending on the amount injected. The interesting thing about Botox is that it tends to work fairly well even up to the third month, as a procedure that might last a very short time at full strength and then go away quickly (filler injections such as Restylane, Perlane, or Juvederm tend to last approximately six to 12 months, depending on the amount used).
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).
Botox only lasts three to six months—and yet what's less commonly discussed is this: Facial muscles naturally weaken over time and going overboard in a certain area could have unwanted consequences. "If you do too much Botox on your forehead for many, many years, the muscles will get weaker and flatter," cautions Wexler, adding that the skin can also appear thinner and looser. Moreover, as your muscles become weaker, they can start to recruit surrounding muscles when you make facial expressions. "If one stops using their forehead muscles, they may start squinting using their nose and have wrinkles along the side of their nose," she explains. Translation: You need even more Botox for the newly recruited muscles, says Wexler. To avoid these kind of missteps, researching a doctor diligently is essential, as is approaching injectables conservatively, and asking questions about how the treatment will be tailored to your needs.
The recommended dilution is 200 Units/4 mL or 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL (see Table 1). The recommended dose for treating chronic migraine is 155 Units ad ministered intramuscularly using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections should be divided across 7 specific head/neck muscle areas as specified in the diagrams and Table 2 below. A one inch needle may be needed in the neck region for patients with thick neck muscles. With the exception of the procerus muscle, which should be injected at one site (midline), all muscles should be injected bilaterally with half the number of injection sites administered to the left, and half to the right side of the head and neck. The recommended re-treatment schedule is every 12 weeks.
In 2010, Allergan pleaded guilty and agreed to pay $600 million to resolve allegations that it unlawfully promoted Botox for conditions--including headaches, pain, spasticity and juvenile cerebral palsy--that at the time were not approved by the FDA. In one of the complaints, prosecutors said that Allergan "illegally, vigorously and without any thought to the possible negative health effects to which it subjected patients, promoted off-label uses of Botox." The U.S. Department of Justice also argued that Allergan exploited on-label uses for cervical dystonia--a disorder characterized by extreme neck-muscle contractions--to "grow off-label pain and headache sales." Prosecutors also argued that Allergan paid doctors to give presentations and trainings to other physicians about Botox uses that at the time were off-label.
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.
Children do very well after having this procedure in our clinic and are not upset when they leave. We rarely use sedation. We use distraction and a quick injection method instead. In rare cases, localization of a muscle may be needed using an electromyograph (EMG) machine or electric stimulator. If this is needed we will discuss this before scheduling the injections.
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.
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.
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.