BOTOX® (Botulinum Toxin Type A)
Clinical use of BOTOX® is the result of more than 100 years of study into botulinum toxin type A. BOTOX® is one of the world's most versatile and widely-researched medicines. With more than 1,800 publications on botulinum toxin type A in scientific and medical journals, BOTOX® is considered by some as the penicillin of the 21st Century. BOTOX® is currently approved for 20 indications in approximately 75 countries, bettering the lives of patients suffering from such serious or debilitating conditions as cervical dystonia, blepharospasm, strabismus and severe primary axillary hyperhidrosis (excessive underarm sweating). Millions of patients worldwide have been treated therapeutically with BOTOX® over the course of nearly 20 years, and Allergan is honoring its commitment to these patients through the provision of quality product, patient and physician education, and the continued pursuit of novel neurotoxin-based therapeutics. In the United States, BOTOX® is current being investigated for the treatment of other medical conditions, including chronic migraine, post-stroke spasticity, and overactive bladder.
BOTOX® is a purified protein that works by blocking overactive nerve impulses that trigger excessive muscle contractions or glandular activity. The effect is temporary and lasts from approximately one to six months, depending on the individual patient and indication. BOTOX® therapy should only be administered by a trained and qualified physician. Approved therapeutic indications for BOTOX® in the United States include the following:
Blepharospasm
Patients with blepharospasm experience an involuntary clenching of the muscles that control the eyelid, causing uncontrollable blinking that generally affects both eyes. In severe cases, blepharospasm can force the eye closed and result in functional blindness. Blepharospasm affects approximately 25,000 people in the United States.1 In 1989, the U.S. Food and Drug Administration (FDA) approved BOTOX® neurotoxin for the treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in adults and children 12 years of age and older. Therapy with BOTOX® is a generally accepted standard of care for blepharospasm, and involves the injection of small therapeutic doses directly in the affected muscles around the eye to relieve the excessive muscle contractions.
Cervical Dystonia
Cervical dystonia, also called spasmodic torticollis, is characterized by involuntary contractions of the neck muscles that cause twisting, repetitive movements, or abnormal postures of the head. The muscle contractions hinder normal movement and can cause severe, chronic neck pain. Cervical dystonia belongs to a group of movement disorders collectively known as "focal dystonias," that affect more than 300,000 people in North America.2 While awareness of this condition is extremely limited, cervical dystonia is the third most common movement disorder, after Parkinson's disease and tremor,3 affecting approximately 125,000 people in the United States.4 BOTOX® received approval from the FDA in 2000 for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.
Severe Primary Axillary Hyperhidrosis
Hyperhidrosis is the medical term for excessive sweating, which is a common chronic condition affecting an estimated 7.8 million people in the United States.5 Hyperhidrosis can cause dehydration and skin problems. Patients with hyperhidrosis produce an amount of sweat that far exceeds that needed to regulate body temperature. BOTOX® was approved by the FDA in 2004 for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating) that is inadequately managed with topical agents. BOTOX® therapy is administered through tiny injections into the underarms to inhibit the release of a neurotransmitter, acetylcholine, from nerve cells, blocking the signals that stimulate the eccrine glands to produce sweat.
Strabismus
Strabismus (crossed eyes) is a visual defect that results when the eyes do not properly align with each other. It is caused by weakness or other problems with one or more of the muscles surrounding each eye that coordinate eye movement and position the eyes to focus in the same direction. Strabismus usually develops during childhood, but can occur at any age and may affect between 5 and 15 million people in the United States.6 The misalignment of the eye may be constant, or may come and go, but does not often resolve without medical intervention. Left untreated, strabismus can result in serious vision problems. In 1989, the FDA granted approval of BOTOX® for strabismus associated with dystonia in patients 12 years of age and older. Therapy with BOTOX® neurotoxin involves the injection of small therapeutic doses directly into the muscles surrounding the eye and provides a minimally-invasive alternative to surgery for selected strabismus patients.
Important Safety Information
BOTOX® treatments are contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs further injection of BOTOX® should be discontinued and appropriate medical therapy immediately instituted. BOTOX® should only be diluted with 0.9 percent nonpreserved sodium chloride. Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX® with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® . There have been rare reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.
BOTOX® for Blepharospasm
Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal ulceration. The most frequently reported treatment-related adverse reactions in these patients are ptosis (20.8 percent), superficial punctate keratitis (6.3 percent) and eye dryness (6.3 percent).
BOTOX® for Cervical Dystonia
In cervical dystonia, the most common side effects following injection include difficulty swallowing (dysphagia) (19 percent), upper respiratory infection (12 percent), neck pain (11 percent) and headache (11 percent). There have been rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube.
BOTOX® for Severe Primary Axillary Hyperhidrosis
Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g. hypothyroidism) to avoid symptomatic treatment for hyperhidrosis without the diagnosis and/or treatment of the underlying disease. In severe primary axillary hyperhidrosis, side effects can include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching and anxiety.
BOTOX® for Strabismus
Inducing paralysis in one or more of the extraocular muscles may produce spacial disorientation, double vision or past pointing. The most commonly reported adverse effects are ptosis (15.7 percent) and vertical deviation (16.9 percent).