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(BPT) - In the United States, someone has a stroke every 40 seconds.[i] Though stroke death rates have declined in recent decades, it is a leading cause of serious long-term disability,[ii] taking a toll on both survivors and their caregivers. It’s important to understand the many ways strokes can impact survivors, including a disabling yet often overlooked condition known as spasticity.
It is estimated that approximately one million adult stroke survivors in the United States are living with some form of spasticity,[iii] a condition in which they experience an abnormal increase in muscle tone or stiffness of muscle.[iv] Stroke survivors may not experience spasticity immediately; in fact, it could occur weeks to months afterwards – long after a patient leaves the hospital.[v]
“The focus after someone has experienced a stroke is so commonly on preventing a second stroke that rehabilitation goals can leave patients and their caregivers feeling unprepared for a larger discussion about the post-stroke symptoms they may be experiencing, including spasticity,” said Dr. Atul Patel, Physical Medicine and Rehabilitation physician, Kansas City Bone & Joint Clinic. “It’s critical that patients and caregivers understand that even if a person has been experiencing spasticity for years, there are ways to help manage the condition.”
Spasticity is caused by damage to nerve pathways of the brain or spinal cord that control voluntary movement,[vi] and can impact limbs in both the upper and lower body. Upper limb spasticity (ULS) can affect the thumb, elbow, wrist and fingers,[vi] while lower limb spasticity (LLS) produces muscle stiffness in the ankle and toes.[vi]
Patients with symptoms of spasticity can be treated by a multidisciplinary team of healthcare experts that may include a neurologist, physiatrist (specializing in physical medicine and rehabilitation), physical therapist, occupational therapist, or other specialists depending on the cause of the underlying disorder. Depending on the severity of the condition and the patient’s treatment goals, treatment options for spasticity include oral medications to reduce the tone in the muscle; physical therapy regimens, such as muscle stretching and range of motion exercises, to help prevent shortening of muscles; or an injection of botulinum toxin to help reduce muscle stiffness.[vii]
BOTOX® is a prescription medicine that is injected into muscles and used:
to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity.
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 upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at highest risk if these problems are pre-existing before injection. Swallowing problems may last several months. 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.
Please see additional Important Safety Information below
BOTOX®, a prescription injectable therapy, works by blocking signals from nerves to muscles, reducing those contractions caused by spasticity.[viii] In adult patients diagnosed with upper or lower limb spasticity, BOTOX® is injected by a trained medical specialist – such as a neurologist or physiatrist – using a fine needle directly into the affected muscles. Patients or caregivers who want to learn more about spasticity and where to find a BOTOX® specialist can visit www.botoxspasticity.com.
Living with spasticity can make some of the simplest tasks more challenging. Below are a few tips to help survivors and their caregivers:
Stay physically active. Find an exercise routine that can be performed easily.Manage stress. Practice relaxation exercises, breathing exercises, gentle stretching, and other techniques to help reduce stress.Join a support group. Support groups can allow survivors and caregivers opportunities to share experiences with others dealing with spasticity.
Most importantly, talk to a healthcare provider about symptoms after a stroke. People who experience symptoms of spasticity should continue to seek treatment from a healthcare provider who specializes in the condition to help manage the impact of post-stroke symptoms, as well as to prevent another stroke.
IMPORTANT SAFETY INFORMATION (continued)
BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX® if you: are allergic to any of its ingredients (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.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.
Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in people with prior breathing related problems with spasticity.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you received BOTOX® in the past.
Tell your doctor if you 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.
Other side effects of BOTOX® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.
© 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners.
1) Centers for Disease Control. “Stroke Facts.” Available at https://www.cdc.gov/stroke/facts.htm. Accessed November 27, 2017.2) The Internet Stroke Center. “Stroke Statistics.” Available at http://www.strokecenter.org/patients/about-stroke/stroke-statistics/. Accessed September 19, 2017.3) Data on File, Allergan, Inc. Global Safety and Epidemiology: Spasticity and comorbidity following five disorders: stroke, multiple sclerosis, spinal cord injury, traumatic brain injury, and cerebral palsy in adults, 2009.4) Esquenazi A. Falls and fractures in older post-stroke patients with spasticity: consequences and drug treatment considerations. Clin Geriatr. 2004;12(8):27-35.5) Wissel J, Schelosky LD, Scott J, Christe W, Faiss JH, Mueller J. Early development of spasticity following stroke: a prospective, observational trial. J Neurol. 2010;257(7):1067-1072.6) Mayer NH and Esquenazi A. Muscle overactivity and movement dysfunction in the upper motoneuron syndrome. Phys Med Rehabil Clin N Am 2003;14:855-883.7) Mostoufi SA. Spasticity and its management. Pain Manage Rounds. 2005;2(5):1-6.8) BOTOX® (onabotulinumtoxinA) Prescribing Information, April 2017.