On
April 15, 2002, the 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 the 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
the lowest effective dose should be used.
The study highlighted the 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 the
face, redness at the injection site, and muscle weakness. While the 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 the bacterium Clostridium Botulinum.
What actually occurs is an injectible form of sterile purified toxin,
in a very small dose, is injected into the affected muscles to block and release the
chemical acetylcholine that would otherwise cause contraction in the muscle. The toxin
actually paralyzes the injected muscle.
Interestingly, the Botulinum Toxin has been known for centuries. As
early as 1895, a professor (Emile Pierre van Ermengem of Ellezelles, Belgium) identified
the original toxin from Bacterium Bacilus Botulinus. It was later renamed in the
1920’s as Botulinum Toxin Type A, generic name Botox®, which is a registered
trademark. Dr. Herman Sommer, at the University of California San Francisco subsequently
provided the data sufficient for future medical studies.
In the 1950’s, Dr. Vernon Brooks2
discovered that the Botulinum Toxin, when injected directly into an active or hyperactive
muscle included the release of acetylcholine from motor nerve endings, thus, inducing a
temporary paralysis of a targeted muscle.
In the 1960’s and 1970’s, Dr. Alan Scott, M.D. of the
Smith-Kettlewell Eye Research Foundation began effectiveness testing with monkeys to
determine if the drug might have effective therapeutic modalities.
For the next 20-30 years, Dr. Scott collaborated with Dr. Schantz of
the University of Wisconsin to further develop product samples.3
In the late 1970’s, Dr. Scott formed a company named Oculinum,
where he continued to study the drug with monkeys and in 1978 received permission from the
Food & Drug Administration to test on human clinical studies.
In 1988, Allergan acquired the rights to distribute Dr. Scott’s
Botox® Toxin Type A product. The current manufacturer, Allergan Inc., is located in
Irvine, California.
Current side effects in actual applications are as follows (as a % of
total side effects):
Upper Respiratory Infection – 11%
Neck Pain – 11%
Headache – 11%
Drooping Eyelids – 21%
Eye Dryness – 6%
All others – 40%
