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REPORT CONFIRMS THE SAFETY AND EFFICACY OF BOTOX® FOR
COSMETIC USE
March 19, 2002
ARLINGTON HEIGHTS, Ill. - With the U.S. Food and Drug Administration
(FDA) approval of Botox® for cosmetic use expected soon, another
validation of the injectable's safety is reported in the March
issue of Plastic and Reconstructive Surgery, the official medical
journal of the American Society of Plastic Surgeons. A comprehensive
safety and efficacy report on Botox® co-authored by Alan Matarasso,
MD, and the American Society of Plastic Surgeons Device and Technology
Assessment (DATA) Committee, summarizes available clinical data
on its application and effects.
The report looked at 80 clinical studies documenting the safety
and efficacy of botulinum toxin or Botox® for cosmetic use.
It discussed what botulinum toxin is, how it is prepared, common
cosmetic plastic surgery uses, and such expanded uses as relieving
migraines and excessive sweating. While it has been effectively
used in cosmetic applications for years, it is considered an off-label
use of the drug.
In 2000, almost 787,000 people received Botox® injections
according to ASPS, ranking it among the top five non-surgical
cosmetic plastic surgery procedures. With the expected approval
of Botox® by the FDA for cosmetic purposes, patient demand
is projected to climb significantly higher in the near future.
"The clinical data shows that Botox® is safe and effective
in diminishing forehead lines, frown lines, crows feet and neck
bands," said Dr. Matarasso, a New York plastic surgeon. "It's
easy to use, takes less than five minutes to administer, is virtually
painless, has few side effects and the results can be readily
maintained. It's not surprising it has become one of the most
popular cosmetic procedures plastic surgeons offer."
Botox® works by relaxing targeted muscles to give the skin
a smoother, more refreshed appearance, reducing and often eliminating
surface wrinkles. Its effects typically last three to six months
and the procedure must be repeated to maintain results. Side effects
of treatment are rare due to its mild toxicity, but could include
unwanted muscle paralysis.
Numerous additional cosmetic uses for Botox® have evolved.
It is increasingly being used with other surgical and nonsurgical
facial rejuvenation procedures such as facelifts and eyelid surgeries.
Botox® is also used to diminish vertical "lipstick"
lines, smile creases, and control excessive sweating of the hands
and armpits.
"Botox® is a tremendous product," stressed Dr.
Matarasso. "Its effectiveness and clinical implications have
expanded considerably over the past 20 years and will continue
to prove beneficial in the treatment of other neuromuscular and
cosmetic conditions in the future."
Botox® is currently approved by the FDA for the treatment
of a number of medical conditions including cervical dystonia,
blepharospasm, migraine headaches and Parkinson's disease. The
manufacturer of Botox® anticipates FDA approval for cosmetic
use of the drug by the end of March 2002.
The ASPS Device and Technology Assessment Committee (DATA) evaluates
new information on plastic surgery devices/techniques or new information
on existing technology and approaches. The Committee reports to
the ASPS Board of Directors and works closely with the ASPS Regulatory
Evaluation Group.
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