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 used, and such expanded uses as relieving migraines and excessive sweating. While it has been effectively used in cosmetic applications for year, 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 non-surgical 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 non-surgical, 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.