BOTOX^® is indicated for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia.

BOTOX^® is indicated for the treatment of strabismus (crossed eyes) and blepharospasm (eyelid spasms) associated with dystonia (muscle tightening), including benign essential blepharospasm of VII nerve disorders in patients 12 years of age and above.

The efficacy of BOTOX^® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX^® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.

IMPORTANT SAFETY INFORMATION

Who should not take BOTOX^®

BOTOX^® injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX^® product.

Warnings

Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an allergic reaction or other unusual symptoms such as difficulty swallowing, speaking, or breathing, call your doctor immediately.

Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

Individuals with peripheral motor neuropathic diseases (eg, amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (eg, 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 (difficulty swallowing) and respiratory compromise from typical doses of BOTOX^®. Published medical literature has reported rare cases of administration of a botulinum toxin to patients with known or unrecognized neuromuscular disorders where the patients have shown extreme sensitivity to the systemic effects of typical clinical doses. In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube.

Dysphagia (difficulty swallowing) is a commonly reported adverse event following treatment of cervical dystonia patients with all botulinum toxins. In these patients, there are reports of rare cases of dysphagia severe enough to warrant the insertion of a gastric feeding tube. There are also rare case reports where subsequent to the finding of dysphagia, a patient developed aspiration pneumonia and died.

Precautions

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

Patients with cervical dystonia should be informed of the possibility of experiencing dysphagia (difficulty swallowing), which is typically mild to moderate. Rare consequences of severe dysphagia include aspiration, dyspnea, pneumonia, and the need to reestablish an airway.

As with any treatment with the potential to allow previously sedentary patients to resume activities, the sedentary patient should be cautioned to resume activity gradually following the administration of BOTOX^®.

Side effects

In general, adverse events occur within the first week following the 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.

In cervical dystonia, the most common side effects following injection include difficulty swallowing, upper respiratory infection, neck pain, and headache.

In blepharospasm, the most common side effects following injection include ptosis, inflammation of the cornea, and eye dryness.

In strabismus, the most common side effects following injection include ptosis and vertical deviation.