The incidence of UTI increased in patients who experienced a maximum post-void residual (PVR) urine volume ≥200 mL following BOTOX injection compared to those with a maximum PVR <200 mL following BOTOX injection, 44% versus 23%, respectively. No change was observed in the overall safety profile with repeat dosing during an open-label, uncontrolled extension trial.
I’ve had migraines since I was 12, but in 2015 my attacks got much worse. Without migraine-specific painkillers, my migraines make me queasy and tired, forcing me to go to bed with a freezing wet towel on my head. For the last two years, I’ve tried different medications, switched birth control pills, made lifestyle changes (less stress, more swimming, no alcohol) — to little avail. My migraines would improve for a while, but then they came back, worse than ever. Then this year, I finally discovered a treatment that works — Botox.
Other adverse reactions that occurred more frequently in the BOTOX group compared to the placebo group at a frequency less th an 1% and potentially BOTOX related include: vertigo, dry eye, eyelid edema, dysphagia, eye infection, and jaw pain. Severe worsening of migraine requiring hospitalization occurred in approximately 1% of BOTOX treated patients in Study 1 and Study 2, usually within the first week after treatment, compared to 0.3% of placebo-treated patients.
In the mid- to late-1990’s dermatologists were the first to report headache relief to migraineurs who were receiving BOTOX injections to reduce facial (forehead) wrinkles. Initially there was significant controversy about whether BOTOX really did help migraine patients. The use of BOTOX for treatment of tension headaches was studied and found to be no more effective than placebo. With migraines, it was more complex. In 2009 the data showed that BOTOX injected in particular areas of the head and neck in patients who met the International Classification of Headache Disorders criteria for chronic migraine provided sufficient benefit to recommend the treatment modality. In 2010, the FDA approved BOTOX for chronic migraine and recommended the protocol of injections and treatment frequency that had been successful in the studies.
A double-blind, placebo-controlled study enrolled patients who had extended histories of receiving and tolerating BOTOX injections, with prior individualized adjustment of dose. The mean BOTOX dose administered to patients in this study was 236 Units (25th to 75th percentile range of 198 Units to 300 Units). The BOTOX dose was divided among the affected muscles [see Clinical Studies].
BOTOX® can be used on the forehead lines, frown lines, crow’s feet, bunny lines (lines in the nose), chin (for dimpling), skin bands on the neck, and around the mouth (for smoker’s lines and down-turned corners of the mouth). Wrinkles caused by sun damage and gravity often will not respond to BOTOX®. It is important to re-emphasize that BOTOX® is NOT a facial filler (that is, it does not fill existing wrinkles) – it merely relaxes the muscles that are creating those wrinkles.
In my experience, this, like all other treatments we use in medicine, doesn’t benefit every patient. I find that it helps a majority of appropriate patients, that is, those patients with a diagnosis of chronic migraine who have failed not just abortive but also preventative migraine treatments. Is there sufficient benefit, however, to outweigh the cost and pain of this treatment? In the case of most of my patients, the answer is yes.
The use of Botox for migraines was, like many other new applications for the drug, a kind of happy accident. A Beverly Hills plastic surgeon observed that people who got Botox for wrinkles were reporting fewer headaches, paving the way for studies about migraines. Similarly, doctors in Europe were intrigued when they noticed that their patients who got Botox for facial spasms were sweating less than usual.
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).
There are eight types of botulinum toxin, named type A–H. Types A and B are capable of causing disease in humans, and are also used commercially and medically. Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals. Type H is considered the deadliest substance in the world – an injection of only 2 ng can cause death to an adult. Botulinum toxin types A and B are used in medicine to treat various muscle spasms and diseases characterized by overactive muscle. Commercial forms are marketed under the brand names Botox and Dysport, among others.
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.