Please see below for BOTOX® Cosmetic, NATRELLE®, and LATISSE® IMPORTANT SAFETY INFORMATION.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and 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 any time (hours to weeks) after injection of BOTOX® Cosmetic:
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); 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; had surgery on your face; weakness of forehead muscles, such as 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 breast-feed (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 [eg, 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 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 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure 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: 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.
Breast Augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
Breast implant surgery should NOT be performed in:
Safety and effectiveness have not been established in patients with the following:
The most commonly reported adverse events for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), implant rupture, and Baker grade III/IV capsular contracture.
Other potential complications for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants include: swelling, implant malposition, pain, ptosis, infection, changes in breast sensation, nipple complications, seroma, delayed wound healing, hematoma, scarring, asymmetry, wrinkling/rippling, extrusion, implant palpability/visibility, and upper pole fullness.
The most commonly reported adverse events for Natrelle® Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), Baker grade III/IV capsular contracture, implant malposition, and asymmetry.
Other potential complications for Natrelle® Silicone-Filled Breast Implants include: unsatisfactory results, pain, changes in nipple and breast sensation, infection, hematoma/seroma, difficulties breastfeeding, calcium deposits in the tissue around the implant, extrusion, necrosis, delayed wound healing, breast tissue atrophy / chest wall deformity, and lymphadenopathy.
Important: For full safety information please visit www.natrelle.com or call Allergan Product Support at 1-800-433-8871.
Caution: Natrelle® 410 Breast Implants are available by prescription only.
LATISSE® (bimatoprost ophthalmic solution) 0.03% Important InformationIndication
LATISSE® is a prescription treatment for hypotrichosis (inadequate or not enough lashes) to grow eyelashes longer, fuller, darker.Important Safety Information
If you use/used prescription products for eye pressure problems, use LATISSE® under doctor care. LATISSE® may cause increased brown pigmentation of the colored part of the eye which is likely permanent. Eyelid skin darkening may occur and may be reversible. Only apply at the base of upper lashes. DO NOT APPLY to lower lid. Hair may grow on skin that LATISSE® frequently touches. If you have eye problems/surgery, consult your doctor about use of LATISSE®. Common side effects are itchy and red eyes. If discontinued, lashes gradually return to previous appearance.
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 click here for full LATISSE® Prescribing Information.