Indications
BOTOX® is approved 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 approved for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or 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.
BOTOX® is approved for excessive underarm sweating when topical agents don’t work.
BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18 to 65.
Important Safety Information
Who should not be treated with 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 unsual 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.
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®.
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.
Precautions
Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders arise.
Side effects
Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising may be associated with the injection.
In cervical dystonia, the most common side effects following injection include difficulty swallowing (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).
In blepharospasm, the most common side effects following injection include ptosis (20.8%), inflammation of the cornea (6.3%), and eye dryness (6.3%).
In strabismus, the most common side effects following injection include ptosis (15.7%) and vertical deviation (16.9%).
The most common side effects following injection of BOTOX
® for excessive underarm sweating when topical agents don’t work include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching, and anxiety.
The most common side effects following BOTOX
® Cosmetic injections include temporary eyelid droop and nausea.
Additional Important Safety Information
The FDA on April 30, 2009, in its update to the early communication sent in 2008, gave the following recommendations:
- Understand that dosage strength (potency) expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.
- Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
- Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.
- Advise patients to seek immediate medical attention if they develop any of these symptoms.