Blepharospasm is a disorder of the muscles that control eyelid movement. Spasms of the eyelid lead to frequent blinking. Blepharospasm often affects both eyelids, making it difficult to open the eyelids. In severe cases, this debilitating condition can lead to what is known as "functional blindness" because the patient is unable to open or keep open the eyelids for any significant period of time.
Approximately 75% of patients with blepharospasm are female and the average age at onset is 56 years.¹ Although the exact cause of this disorder is unknown, experts believe that it may be caused by an inappropriate signal in the part of the brain known as the basal ganglia.²

Doctors diagnose blepharospasm based on key signs and symptoms. In the early stages of blepharospasm, patients may complain of irritation and discomfort of the eyelids as well as an increase in blinking. As the blepharospasm progresses over two years, blinking usually becomes more frequent, forceful, and uncontrollable. Bright, dazzling, or flickering lights, dusty or smoky air, or high-speed travel by train or car can make the symptoms worse. Without proper medical treatment, most patients with blepharospasm do not recover.

When injected directly in the affected eye muscles, the neurotoxin relieves the muscle spasm. Although the effect is temporary, BOTOX® can be reinjected approximately every three months as long as the patient continues to respond and does not have a serious allergic reaction.³

Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal ulceration, especially in patients with VII nerve disorders. The effects of therapy may be increased with the use of aminoglycoside antibiotics or with other drugs that interfere with neuromuscular transmission.

The most frequently reported adverse events associated with BOTOX® include ptosis (20.8%), superficial punctate keratitis (6.3%), and eye dryness (6.3%).⁴ Other events reported in prior clinical studies, in decreasing order of incidence, include irritation, tearing, lagophthalmos, photophobia, entropion, keratitis, diplopia, diffuse skin rash, and local swelling of the eyelid skin lasting for several days following eyelid injection.

As with any treatment that may result in resumption of activities by previously sedentary patients, sedentary patients should be cautioned to resume activity gradually following the administration of BOTOX®.³ In general, adverse events occur within the first week following injection of BOTOX® and while generally transient may have a duration of several months. Localized pain, tenderness and/or bruising may be associated with the injection. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of adjacent muscles may also occur due to spread of toxin.

1. Henderson JW. Essential blepharospasm. Trans Am Ophthalmol Soc. 1956;54:453-520.
2. Dystonia Medical Research Foundation. Available at: http://www.dystonia-foundation.org/. Accessed January 12, 2001.
3. BOTOX® Full Prescribing Information.
4. Data on file, Allergan, Inc. 1997.

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Strabismus, also known as crossed eyes, is a disorder in which eyes are misaligned. In adults, strabismus can occur gradually or rapidly. Gradual onset is usually the result of movement of the eye due to loss of muscle tone. Rapid onset, on the other hand, may be an indication of significant head trauma or serious systemic illness.

Diagnosis of strabismus is based primarily on the patient's medical history. Ophthalmologic and neurologic testing should be performed to rule out possible diseases of the eye or brain. In the most common form of strabismus, the eye turns inward toward the nose. In other forms, the eye may turn away from the nose or may turn upward or downward. Generally, the eyes turn in different directions from each other.

BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex was approved as a therapy for strabismus in adults in December 1989. It is thought to work by lengthening the injected muscle while shortening the opposing muscle. The duration of effect is approximately three months. If necessary, the neurotoxin can be reinjected as long as the patient continues to respond and does not have a serious allergic reaction.¹

During the administration of BOTOX® for the treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred from needle penetration into the orbit.

BOTOX® treatments may, on occasion, adversely affect muscles next to the injection site causing eyelid drooping or vertical deviation, especially if higher doses of BOTOX® are required as part of the treatment regimen. The treatments may also cause paralysis in one or more muscles outside the eyeball, causing spatial disorientation, double vision, or pastpointing.¹

1. BOTOX® Full Prescribing Information.

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Cervical dystonia (CD), also known as spasmodic torticollis, belongs to a group of disorders known as focal dystonias. Patients with CD have involuntary contractions of the neck and shoulder muscles that cause the head to twist in abnormal positions.¹ Neck muscles may also contract repetitively, producing uncontrollable head movements.

Head and neck movements may occur in any direction. The chin may twist toward the shoulder, or the head may tilt forward, backward, or to the side.

CD occurs in 9 out of every 100,000 individuals.⁴ Approximately 5% to 16% of patients with CD have a history of head or neck trauma preceding the onset of dystonia.3 The cause of CD, however, is not yet known.

The most obvious clinical sign in patients with CD is an abnormal head position. The movement abnormalities and pain associated with CD can be disabling. Although onset may occur at any age, CD typically occurs in adults between the ages of 30 and 70. Women are nearly twice as likely to be affected with CD as men.⁴

Some patients develop sensory tricks (geste antagoniste) to help them cope with the pain associated with CD. By touching their faces, chins, or heads, individuals can temporarily reduce or compensate for the dystonic symptoms. Many patients even develop sensory tricks to help them improve posture during social situations.

BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex blocks the nerve impulses that trigger muscle activity. The neurotoxin is thought to chemically inhibit the release of the neurotransmitter acetylcholine from nerve endings by binding to certain receptors on cholinergic terminals. It is then engulfed by the nerve endings. Once inside a nerve ending, the neurotoxin interferes with the cholinergic vesicles that release acetylcholine. This interference leads to chemodenervation and reduced muscular contractions.

The National Institutes of Health (NIH), American Academy of Neurology (AAN), and American Academy of Ophthalmology (AAO) have recognized BOTOX® as a safe and effective treatment for the symptomatic relief of CD.

The duration of effect for each BOTOX® treatment is approximately three months. Patients eventually return to pretreatment status at which point they can be reinjected over time with the neurotoxin as long as they continue to respond and do not have a serious allergic reactions.⁵

Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders occur.⁵

Patients with CD should be informed of the possibility of having difficulty swallowing (also known as dysphagia), which is typically mild to moderate, but could be severe. Rare consequences of severe dysphagia include aspiration, shortness of breath, pneumonia, and the need to reestablish an airway.⁵

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®. The effects of therapy may be increased with the use of aminoglycoside antibiotics or with other drugs that interfere with neuromuscular transmission. There have been rare spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility, after treatment with botulinum toxin.

The most frequently reported side effects associated with BOTOX® include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).6 Other events reported in 2% to 10% of patients, in decreasing order of incidence, include increased cough, flu syndrome, back pain, rhinitis, dizziness, hypertonia, soreness at the injection site, asthenia, oral dryness, speech disorder, fever, nausea, and drowsiness.⁵

In general, adverse events occur within the first week following injection of BOTOX® and while generally transient may have a duration of several months. Localized pain, tenderness and/or bruising may be associated with the injection. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of adjacent muscles may also occur due to spread of toxin.

1. Fahn S, Marsden CD, Calne DB. Classification and investigation of dystonia. Mov Disord. 1987;2:332-358.
2. Data on File, Allergan, Inc.
3. Van Zandijcke M. Cervical dystonia (spasmodic torticollis). Some aspects of the natural history. Acta Neurol Belg. 1995;95(4):210-215.
3. Chan J, Brin MF, Fahn S. Idiopathic cervical dystonia: clinical characteristics. Mov Disord. 1991;6:119-126.
4. BOTOX® Full Prescribing Information.
5. Data on file, Allergan, Inc. 1999

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Botulinum toxin (Botox) works by weakening the muscles of facial expression which insert on the under surface of facial skin. Once the resting tone of these muscles are weakened, the pull of the muscles relax and the skin flattens out. This is an entirely different approach to treating the aging face. Collagen and fat injections work by filling in a wrinkle. These fillers are not as effective as Botox in improving the frown wrinkles between the eyebrows. By physiologically weakening the muscles, these wrinkles are removed naturally.

Botox takes 3-5 days to take effect and lasts between 3-6 months. Botox is most effective for the frown lines between the eyebrows, but can also be used to lessen the horizontal wrinkles in the central portion of the forehead, and crows feet at the corner of the eyes. It is not effective for wrinkles in the middle and lower portion of the face.

You will feel a small amount of discomfort when the needle pierces the skin, and when the Botox is injected. This will last for approximately 5 seconds. On rare occasions, the needle may puncture a blood vessel and you may have slight bruising that lasts for up to 7 days. This possibility can be diminished by avoiding the intake of aspirin or aspirin like products for several days prior to the injection. There are no serious side effects associated with the use of Botox and the doses that are employed. Side effects can be caused if the Botox migrates from the injections sites. For this reason, it is wise to avoid massaging the area for 12 hours after the injection. Possible side effects include a limited droop of the eyebrow or upper eyelid. Fortunately, if this occurs, it is temporary but may last 2-3 weeks. This eyelid droop can be lessened with the use of eye drops. Botox is administered in the office by an injection directly into the muscles causing the wrinkles. You can then immediately resume full activities.

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