BOTOX® Cosmetic and BOTOX® (Botulinum Toxin Type A) By the Numbers
- 3,181,592: Number of BOTOX® Cosmetic treatments administered in the United States in 2006 alon
- 1,000,000s: People who received treatment with BOTOX® for medical and aesthetic purposes around the world
- 300,000: Number of men who received treatment with BOTOX® Cosmetic in 2006
- 10,000: People in clinical trials
- 3,000: Publications on Botulinum Toxin Type A in scientific and medical journals
- 100: Years of study into botulinum neurotoxins
- 97: Percentage of people satisfied with their BOTOX® Cosmetic treatment based on a survey of approximately 1,000 patients
- 75: Countries around the world who have approved use of BOTOX®
- 20: BOTOX® indications approved by regulatory authorities around the world, including the aesthetic indication
- 18: Years since U.S. Food and Drug Administration (FDA) approved BOTOX® to treat excessive eye blinking and crossed eyes
- 11: Descriptor for the glabellar (vertical) lines between the brows which can be treated with BOTOX® Cosmetic, that can help improve one’s overall facial appearance
- 8: Years since FDA approval of BOTOX® for the treatment of cervical dystonia (painful neck twisting condition) in adults
- 6: Years since FDA approval of BOTOX® Cosmetic for the treatment of the moderate to severe
- glabellar (vertical) lines between the brows in adults 18 to 65
- Years since FDA approval of BOTOX® for the treatment of severe primary hyperhidrosis (excessive
- underarm sweating) inadequately managed with topical agents
- 1: Rank of BOTOX® Cosmetic on list of “Top 5 Surgical & Nonsurgical Physician Administered
Cosmetic Procedures,”viii according to American Society for Aesthetic Plastic Surgery
About BOTOX® (Botulinum Toxin Type A) BOTOX® is a medical product that contains tiny amounts of highly purified botulinum toxin protein refined from a bacterium. The product is administered in small therapeutic doses by injection directly into the
affected area, and works by blocking the release of acetylcholine (a neurotransmitter that signals the
muscles to contract) at the neuromuscular junction.
BOTOX® neurotoxin therapy was granted approval by the FDA in 1989 for the treatment of strabismus
(crossed eyes) and blepharospasm (uncontrollable eye blinking) 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® neurotoxin has since received approval in December 2000 for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. In 2002, with dosing specific to treat frown lines between the eyebrows, the product was approved by the FDA for the temporary improvement in the appearance of moderate to severe glabellar lines (the vertical “frown lines” between the eyebrows) in adult men and women aged 65 and younger, under the name BOTOX® Cosmetic. More recently, in July 2004, BOTOX® was granted FDA approval for the treatment of severe primary axillary hyperhidrosis (excessive underarm sweating) that is inadequately managed with
topical agents.
Important Risk Information
BOTOX® and BOTOX® Cosmetic treatment should not be injected in the presence of infection at the
proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.
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. 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® or BOTOX® Cosmetic with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic side effects with BOTOX® or BOTOX® Cosmetic.
BOTOX® for Blepharospasm in Patients > 12 Years of Age: Reduced blinking from BOTOX® injection of
the orbicularis muscle can lead to corneal exposure, persistent epithelial defect and corneal perforation.
The most frequently reported treatment-related adverse reactions in these patients are ptosis (20.8%),
superficial punctate keratitis (6.3%) and eye dryness (6.3%).
BOTOX® for Strabismus in Patients > 12 Years of Age: Inducing paralysis in one or more extraocular
muscles may produce spatial disorientation, double vision or past pointing. The most commonly reported
adverse effects are ptosis (16%) and vertical deviation (17%).
BOTOX® for Cervical Dystonia in Adults: There have been rare cases of dysphagia severe enough to
warrant the insertion of a gastric feeding tube. The most frequently reported adverse reactions in patients
with cervical dystonia are dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and
headache (11%).
BOTOX® for Severe Primary Axillary Hyperhidrosis Inadequately Managed with Topical Agents: The
most frequently reported adverse events (3 - 10%) are injection site pain and hemorrhage, non-axillary
sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.
BOTOX® Cosmetic for Temporary Improvement in the Appearance of Moderate to Severe Frown
Lines Between the Brows in adults <65: The most common side effects following injection include
temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness
and/or bleeding/bruising may be associated with the injection.
For full prescribing information for BOTOX® and BOTOX® Cosmetic, please visit www.BOTOXMedical.com
or www.BOTOXCosmetic.com.
© 2008 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc.
i
American Society for Aesthetic Plastic Surgery Quick Facts http://www.surgery.org/download/2006stats.pdf
ii
Allergan press release “Allergan, Inc Responds to Public Citizen’s Allegation Regarding a Fatality Following BOTOX® Cosmetic
Treatment” 01/25/08
iii
American Society for Aesthetic Plastic Surgery Quick Facts http://www.surgery.org/download/2006stats.pdf
iv
Allergan press release “Allergan, Inc Comments on BOTOX® (Botulinum Toxin Type A) Safety Profile” Released 01/24/08
v
BOTOX® History and Development Fact Sheet, updated 01.04.08
vi
BOTOX® History and Development Fact Sheet, updated 01.04.08
vii
Aesthetic Surgery Education & Research Foundation press release “First-of-its-kind Survey Finds That BOTOX Cosmetic has
Gone Mainstream” Released 04/28/06
viii
American Society for Aesthetic Plastic Surgery Top 5 Surgical & Nonsurgical Cosmetic Procedures
http://www.surgery.org/download/2006-Top5.pdf