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The history of BOTOX® Cosmetic is a remarkable story of how a potent substance found in nature has been harnessed for both medical and aesthetic benefits.
Years ago, Allergan acquired a product called onabotulinumtoxinA and saw its potential. The company conducted clinical trials and submitted the data to the FDA, which shepherded the product’s first approved therapeutic use.
OnabotulinumtoxinA received FDA approval for therapeutic use in 1989 and was rebranded BOTOX®. Through expanded research into aesthetic uses, Allergan later commenced clinical trials to study the treatment’s safety and efficacy for moderate to severe frown lines.
On April 15, 2002, the FDA approved BOTOX® as a temporary aesthetic treatment for moderate to severe frown lines in adults, and requested the product be marketed as BOTOX® Cosmetic to distinguish aesthetic from therapeutic uses. It was the first treatment of its kind to be approved for an aesthetic use, and today is the only product FDA-approved to temporarily make moderate to severe frown lines, crow’s feet and forehead lines look better in adults.
BOTOX® Cosmetic quickly became one of the world’s most recognized and iconic brands. Approved for use in 98 countries, BOTOX® Cosmetic has become the #1 selling treatment of its kind around the world.*
Today, the community of patients receiving BOTOX® Cosmetic continues to grow, with approximately 100 million vials sold in the United States alone since 2002.
The safety and effectiveness profile of BOTOX® Cosmetic has been proven in more than 16 years of published research and described in 528 articles in peer-reviewed scientific and medical journals. BOTOX® Cosmetic has become the most widely researched and studied treatment of its kind.
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product .
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you : are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include : dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.