Overall, with the exception of Overactive Bladder (see below), clinical studies of BOTOX did not include sufficient numbers o f subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. There were too few patients over the age of 75 to enable any comparisons. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease o r other drug therapy.
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].
A randomized, multi-center, double-blind, placebo-controlled study of the treatment of cervical dystonia was conducted. This study enrolled adult patients with cervical dystonia and a history of having received BOTOX in an open label manner with perceived good response and tolerable side effects. Patients were excluded if they had previously received surgical or other denervation tre atment for their symptoms or had a known history of neuromuscular disorder. Subjects participated in an open label enrichment period where they received their previously employed dose of BOTOX. Only patients who were again perceived as showing a response were advanced to the randomized evaluation period. The muscles in which the blinded study agent injections we re to be administered were determined on an individual patient basis.
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.
Yes. The number of men receiving cosmetic treatments overall has risen by 325% over the last 20 years. And the number of men specifically choosing treatments like BOTOX® Cosmetic has also risen fast– in the past three years alone, men have received over one million botulinum toxin treatments. When surveyed, the majority of men say they want to look good and they’re bothered by the changes they see in the mirror. 80% would choose to treat their crow’s feet first, while 74% would prioritize their forehead lines, and 60% would most like to treat their frown lines.†
Dr. Schwedt believes ARMR offers hope for patients living with migraine. “ARMR data could lead to breakthroughs in the field,” he says. One hope for ARMR is that it will contribute to the ability for health care providers to use precision medicine to treat their patients. Clinical trials show which migraine therapies are overall effective for groups of people with migraine; however, health care providers are still working to understand which specific therapy is ideal for a particular patient. “One of the challenges we have in this field right now is being able to determine which exact therapy is going to be best for which patient,” Dr. Schwedt says. “For example, we might know that about 50% of patients will benefit from a specific migraine preventive therapy, but we don’t know in advance which 50% that is. I believe the data we’re collecting in ARMR is going to help us get to the stage where we can practice precision medicine, knowing which therapy is most likely to help an individual patient prior to the patient starting that therapy.”
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.
Patients with compromised respiratory status treated with BOTOX for spasticity should be monitored closely. In a double-blind, placebo-controlled, parallel group study in patients treated for upper limb spasticity with stable reduced pulmonary function (defined as FEV1 40-80% of predicted value and FEV1/FVC ≤0.75), the event rate in change of Forced Vital Capacity (FVC) ≥15% or ≥20% was generally greater in patients treated with BOTOX than in patients treated with placebo (see Table 5).
Bronchitis was reported more frequently as an adverse reaction in patients treated for upper limb spas ticity with BOTOX (3% at 251 Units-360 Units total dose), compared to placebo (1%). In patients with reduced lung function treated for upper limb spasticity, up per respiratory tract infections were also reported more frequently as adverse reactions in pati ents treated with BOTOX (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%). In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse event in patients treated with BOTOX (2% at 300 Units to 400 Units total dose) compared to placebo (1%).
For most of our guests, the effects of the treatment can last anywhere from 3-6 months. Many factors can influence how long the effects last. As the product wears off, muscle action returns gradually, & the previously treated lines & wrinkles may begin to reappear, and need to be treated again. With repeated treatment, the lines and wrinkles often appear less severe than before, as the muscles are being trained to relax.Some of these factors that may shorten or lengthen the effects include:
Some doctors and dermatologists recommend lying down and resting after a treatment, but Ravitz says she doesn't think there's any need for downtime unless a patient experiences pain. It can take about two weeks to work, though some patients start to feel relief from chronic migraines sooner than that. Ravitz tells me, "If it’s going to work for a patient, one round of the treatment typically lasts for around three months." Though everybody metabolizes it at a different rate, getting it done every three months or so has been found to be effective.
Ptosis generally occurs from injecting the frontalis incorrectly. The worst mistake is for the injector to move the procerus and corrugator injection points higher, where they will place more onabotulinumtoxinA into the frontalis. It is important to examine patients to determine their preexisting conditions prior to treatment administration. In particular, patients should be examined for pre-existing eyelid ptosis or pseudoptosis. With pseudoptosis, the lid strength is normal, but soft tissue covers part of the upper lid. With lid ptosis, the lid strength is weak. For both lid ptosis and pseudoptosis, patients will have frontalis compensatory activity, resulting in upgoing eyebrows (reverse Babinski sign). With brow ptosis, the frontalis is weak, and the eyebrow is depressed downward leading to tissue resting on the upper lid. To avoid this, the frontalis should be injected in the upper third of the forehead. The corrugator muscle attaches to bone at the medial end of the superciliary arch. The muscle fibers travel laterally and upward inserting into the skin in the middle of the supraorbital margin. The corrugator muscle is partially blended with the orbicularis oculi and occipitofrontalis. The supraorbital and supratrochlear nerves pass through the corrugator muscle. The corrugator muscle acts to pull the eyebrows downward and medially, which causes vertical wrinkle lines in the skin between the brows.
There are no data on the presence of BOTOX in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BOTOX and any potential adverse effects on the breastfed infant from BOTOX or from the underlying maternal conditions.
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.