A skeletal muscle relaxant - It is used to treat moderate to severe frown lines on the face
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Special Alerts:
[Posted 02/07/2008] FDA issued an early communication about an ongoing safety review regarding Botulinum Toxin Type A (Botox and Botox Cosmetic). FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins type A and type B (Myobloc) for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA’s “Early Communication about an Ongoing Safety Review” for Agency recommendations and additional information for healthcare professionals. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#colchicine and http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Botulinum toxin type A (Botox®, Botox® Cosmetic) and type B (Myobloc®) currently are commercially available in the US; types C and F reportedly under clinical investigation in other countries.
Cervical Dystonia
Management of cervical dystonia (also referred to as spasmodic torticollis) to decrease the severity of associated abnormal head position and neck pain; designated an orphan drug by FDA for this use.
Considered first-line therapy for cervical dystonia because of its efficacy, relatively low incidence of adverse effects, and temporary dose-related therapeutic effects (compared with surgery).
Comparative safety and efficacy of botulinum toxin types A and B in cervical dystonia have not been established.
Blepharospasm and Associated Facial Nerve Disorders
Management of blepharospasm associated with dystonia, including benign essential blepharospasm and seventh cranial (facial) nerve disorders; considered a first-line therapy.
Designated an orphan drug by FDA for treatment of blepharospasm associated with dystonia in adults and children ≥12 years of age.
Management of Meige’s syndrome† (idiopathic blepharospasm with facial and oromandibular dystonias).
Strabismus and Nystagmus
Management of dystonia-associated strabismus; designated an orphan drug by FDA for this use. An effective alternative or adjunct to surgery in selected adults and children with congenital or acquired strabismus.
Also has been used in vertical strabismus in dysthyroid ophthalmopathy for which surgery is inappropriate.
Safety and efficacy not established for treatment of ocular deviations >50 prism diopters†, restrictive strabismus†, or Duane’s syndrome with lateral rectus weakness†.
Has been used in surgically overcorrected or undercorrected strabismus; however, efficacy not established in strabismus secondary to prior surgical overrecession of the ocular antagonist muscle.
Not effective in chronic paralytic strabismus except as an adjunct to surgical repair to reduce ocular antagonist muscle contracture.
Spasmodic Dysphonia (Laryngeal Dystonia)
Treatment of choice for management of spasmodic dysphonia† (laryngeal dystonia) despite occasional complications and possible risk of reflex laryngeal stridor. Spasmodic dysphonia involving the adductor muscles appears to be more common; a limited number of patients with abductor muscle spasm have obtained some benefit from EMG-guided injections of the toxin into the posterior cricoarytenoid muscle.
Oromandibular Dystonias
Has been used successfully in the management of various oromandibular dystonias† (e.g., Meige’s syndrome†); considered a treatment of choice by some clinicians, although efficacy evidence from well-controlled studies is lacking.
Focal Limb Dystonias
Has been used for the management of focal limb dystonias (e.g., writer’s cramp†); considered first-line therapy.
Tremor
Has been used for the management of various types of tremor†, including hand tremor†.
Axillary Hyperhidrosis
Management of severe primary axillary hyperhidrosis that has not responded adequately to conservative treatments (e.g., topical antiperspirants).
Requires repeated treatment but avoids associated morbidity (e.g., pneumothorax, Horner’s syndrome, compensatory hyperhidrosis) of surgical procedures.
Gustatory Sweating
Used with good results in patients with gustatory sweating† (e.g., Frey syndrome, diabetic gustatory sweating); considered a treatment of choice by some clinicians, although efficacy data are limited.
Cosmesis of Glabellar Facial (“Frown”) Lines
Used for temporary improvement in the appearance of moderate to severe glabellar facial (“frown”) lines associated with corrugator and/or procerus muscle activity.
A treatment of choice in individuals wishing to avoid major procedure.
Cosmetic effects generally persist at least 4–6 months.
May not be appropriate when a wide range of facial expressions is required for professional or personal reasons.
Cosmesis of Lateral Canthal Wrinkles (“Crow’s Feet”)
Has been used for temporary improvement in the appearance of facial wrinkles associated with hyperactivity of the orbiculus oculi muscle† (lateral canthal wrinkles†, also known as “crow’s feet”†).
Cosmesis of Horizontal Forehead Lines
Has been used for temporary improvement in the appearance of hyperfunctional facial lines caused by frontalis muscle hyperactivity† (horizontal forehead lines).
Young individuals (usually females) with expressive horizontal forehead lines reportedly exhibit the best response.
Spasticity Associated with Cerebral Palsy
Has been used for the treatment of dynamic muscle contracture in pediatric patients with cerebral palsy†; designated an orphan drug by the FDA for this use. Some clinicians suggest conjunctive use of physical therapy and orthotics (e.g., casting).
Also has been used as an adjunct to analgesics for relief of postoperative pain secondary to muscle spasm associated with cerebral palsy† following orthopedic surgery.
Spasticity Associated with Stroke
Has been used to decrease spasticity, improve posture and range of motion, and relieve painful muscle spasms in patients with spasticity associated with stroke†.
Spasticity Associated with Multiple Sclerosis
Has been used for treatment of spasticity associated with multiple sclerosis† (e.g., hip adductor spasms†, spastic ankles†).
Anal Sphincter Disorders
Has been used effectively to treat uncomplicated cases of chronic anal fissure†; circumvents potential complications of surgery.
Has been used for pain reduction following hemorrhoidectomy†, presumably as a result of reducing spasm of the anal sphincter.
Neurogenic Voiding Dysfunction
Has been used for the treatment of detrusor-sphincter dyssynergia† (generally detrusor-external sphincter dyssynergia†) associated with spinal cord disease or injury.
Voiding Dysfunction Associated with Benign Prostatic Hyperplasia
Has been used to treat voiding dysfunction associated with benign prostatic hyperplasia† (benign prostatic hypertrophy, BPH).
Achalasia
Has been used successfully in a limited number of patients to relieve dysphagia, pain, and regurgitation associated with achalasia†; much less effective in achalasia secondary to gastroesophageal junction carcinoma or other malignancy than in idiopathic achalasia.
Musculoskeletal Pain Disorders
Has been used for pain relief in a variety of pain disorders of musculoskeletal origin, including myofascial pain syndrome†, chronic neck pain†, chronic lower back pain†, and whiplash-associated disorder†.
Has also been used for treatment of tennis elbow†.
Prophylaxis of Disabling Headache
Has been used to reduce the frequency of and/or pain associated with migraine headache† in certain patients who require an alternative to conventional drug therapies because of inefficacy, intolerance, contraindications, and/or poor compliance.
Has been used with relatively inconsistent benefit in post-whiplash (cervicogenic) headache†.
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