BOTOX vs. ALL-NATURAL SKIN CAREOn April 15, 2002, FDA approved Botox® to treat frown lines. Botox® was first approved in December 1989 to treat two specific eye muscle disorders, “Blepharospasm” and “Strabismus” and subsequently approved in December 2000 to treat Cervical Dystonia, a neurological movement disorder that causes severe neck and shoulder contractions.1
To gain approval for use with frown lines, a clinical study involving 405 mostly women over 50 with moderate to severe frown lines were injected with Botox® cosmetic and after 30 days frown lines were evaluated. The frown lines were eliminated for approximately 120 days at which time re-injection was required. The FDA guidelines were injections to incur no more frequently than once every three months and lowest effective dose should be used.
The study highlighted following common adverse side effects:
Headache Respiratory infection Flu symptoms Droopy eyelids Nauseous Less frequent but adverse reactions in approximately 3% of patients included pain in face, redness at injection site, and muscle weakness. While adverse reactions were termed temporary, they could last months.
The FDA approved Botox® as a prescription drug, thus, requiring medical supervision. The actual name for Botox® cosmetic is Botulinum Toxin Type A; it’s actually produced from bacterium Clostridium Botulinum.
What actually occurs is an injectible form of sterile purified toxin, in a very small dose, is injected into affected muscles to block and release chemical acetylcholine that would otherwise cause contraction in muscle. The toxin actually paralyzes injected muscle.
Interestingly, Botulinum Toxin has been known for centuries. As early as 1895, a professor (Emile Pierre van Ermengem of Ellezelles, Belgium) identified original toxin from Bacterium Bacilus Botulinus. It was later renamed in 1920’s as Botulinum Toxin Type A, generic name Botox®, which is a registered trademark. Dr. Herman Sommer, at University of California San Francisco subsequently provided data sufficient for future medical studies.
In 1950’s, Dr. Vernon Brooks2 discovered that Botulinum Toxin, when injected directly into an active or hyperactive muscle included release of acetylcholine from motor nerve endings, thus, inducing a temporary paralysis of a targeted muscle.
In 1960’s and 1970’s, Dr. Alan Scott, M.D. of Smith-Kettlewell Eye Research Foundation began effectiveness testing with monkeys to determine if drug might have effective therapeutic modalities.