News Release from Allergan, Inc. on February 8 on BOTOX®:
Allergan, Inc. Today commented on and provided support for the FDA’s “Early Communication” regarding a safety review of BOTOX® in the United States.
The FDA announced this morning that it was reviewing certain serious adverse events following the use of BOTOX®, particularly for the management of juvenile cerebral palsy. The FDA made clear in its communication that “the posting of this information does not mean that there is a causal relationship between the products and the adverse events.”
Importantly, the FDA hosted a public teleconference this afternoon in which it provided helpful clarification and context, explaining that this review involves only “a relative handful of serious adverse events” and that the primary focus of the adverse events and the FDA’s review of them related to the therapeutic use of BOTOX® to treat juvenile cerebral palsy and other large muscle, lower limb spasticities.
With respect to the therapeutic use of BOTOX® to treat juvenile cerebral palsy and other lower limb spasticities, one should keep in mind that the population, treatment paradigms and typical dosing of product is significantly greater than some of the other approved uses of the product, including specifically the FDA-approved use of BOTOX® Cosmetic to treat wrinkles between the brows.
In its “Early Communication,” the FDA reported dose in the serious adverse events “ranged from 100 to 700 units” while the approved dosing for BOTOX® Cosmetic is 20 units.
Importantly, the FDA confirmed in the teleconference that none of the adverse events that are the subject of its review relate to a death involving the use of BOTOX® Cosmetic for an aesthetic use. “Since its approval, over a million people have been treated with BOTOX® Cosmetic. In its entire history, there has never been a single reported death where a causal link to BOTOX® Cosmetic was established,” said Dr. Sef Kurstjens, Allergan’s Chief Medical Officer.
About:
As we get older, wrinkles begin to line our once-smooth face. The natural, physical display of our emotions, such as laughter and frowns, leave their stamp around our lips and dyes. Though some companies offer creams that claim to lessen the appearance of lines and wrinkles, physician-administered treatment is the only way to effect real change in moderate to severe lines, especially that tough spot between the brows. The injection of Botulinum Toxin (BOTOX®) can fill in various facial furrows caused over time by natural muscle movement.
BOTOX® has proven popular with patients, as the treatment is simple, quick and nonsurgical, and you can often see a difference after only a few days. However, the effects are not permanent; you will have to return for treatment after a few months. How often you must go back depends on factors such as skin elasticity, age and treatment site.
Is This Procedure for You?
BOTOX® is suitable for people of all ages, except those who are pregnant or breastfeeding, allergic to ingredients in BOTOX® or have an infection in the area to be treated. Those who have neuromuscular disorders should proceed with caution, as they may experience serious side effects from the treatment. Speak with Dr. Moore if you have such a disorder or any other concerns.
To learn more about this procedure and what Dr. Moore can do for you, call (615) 771-7718 or click here to schedule an appointment online today.
Procedure Details:
Initial Consultation
In your initial consultation, one of Dr. Moore's qualified and skillfully trained Registered Nurses will evaluate your health, discuss your medical history and assess the contours of your face. They will then review your goals and make recommendations based on their evaluation. The techniques used in BOTOX® injection will be described in detail, and informational materials will be provided. Be sure to notify them of any medicine you are taking and if you have any allergies, active skin issues or illnesses that affect your nerves and muscles.
What to expect
In most cases, the procedure will be performed on an outpatient basis and will typically take about 10 minutes.
During the Procedure
Generally, no anesthesia is required in BOTOX® injections, although sometimes topical anesthetic cream will be used to numb the area. You will be asked to move certain facial muscles in order to determine the best points to inject BOTOX®. The substance will be injected directly into the muscles at several points in the area to be treated.
Post-Procedure
After the procedure, you are free to continue with your normal activities. You may experience some side effects, such as eyelid droop and nausea, but these will disappear soon. Other possible side effects include pain, swelling, bruising, infection and redness.
Discuss with Dr. Moore how often you should repeat BOTOX® treatments. Generally, follow-up treatments will be required every three to four months.
The New You!
You will love your new smoother appearance. Feel the freedom to laugh, smile and frown—without those pesky lines!
Insurance
Most health insurance plans do not cover cosmetic procedures. In some instances, if you attempt to secure insurance reimbursement for cosmetic procedures, your insurance company may view it as fraud.
Costs
Costs are dependent upon your individual goals and needs.
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