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Courtney Thorne-Smith Is Involved with a Campaign That's Aimed at Providing Women with the Information that They Need to Make Well-Informed Decisions about Treatment with BOTOX® Cosmetic
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX Cosmetic is a prescription medicine that is injected into muscles, and is used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).
Important Safety Information
BOTOX Cosmetic may cause serious side effects that can be life-threatening. Call your doctor or get medical help right away, if you have any of these problems anytime (hours to weeks) after injection of BOTOX Cosmetic:
• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
• Spread-of-toxin effects: The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness; double vision, blurred vision, and drooping eyelids; hoarseness or change or loss of voice (dysphonia); trouble saying words clearly (dysarthria); loss of bladder control; trouble breathing; or trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
The dose of BOTOX Cosmetic is not the same as, or comparable to, another 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.
Serious and/or immediate allergic reactions have been reported. They include: itching; rash; red, itchy welts; wheezing; asthma symptoms; or dizziness or feeling faint. Tell your doctor or get medical help right away, if you are wheezing or have asthma symptoms--or if you become dizzy or faint.
Do not take 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); or have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions--such as: amyotrophic lateral sclerosis (ALS or "Lou Gehrig's disease"); myasthenia gravis; or Lambert-Eaton syndrome--as you may be at increased risk of serious side effects, including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing), from typical doses of BOTOX Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; having had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; being pregnant or planning to become pregnant (as it is not known if BOTOX Cosmetic can harm your unborn baby); or breast-feeding or planning to breast-feed (as it is not known if BOTOX Cosmetic passes into breast milk).
Human albumin and spread of viral diseases: BOTOX Cosmetic contains albumin--a protein component of human blood. The potential risk of spreading viral diseases (e.g., Creutzfeldt-Jakob Disease [CJD]) via human-serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human-serum albumin.
Tell your doctor about all the medicines that you take--including prescription and nonprescription medicines, vitamins, and herbal products. 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.
Especially tell your doctor if you: have received any other botulinum-toxin product in the last four months; have received injections of botulinum toxin--such as Myobloc, Dysport, or Xeomin--in the past (and be sure that your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.
Other side effects of BOTOX Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information, refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please refer to BOTOX Cosmetic's full Product Information--including Boxed Warning and Medication Guide--at www.botoxcosmetic.com.
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