| |
|
When did BOTOX® Cosmetic Injections get approved?
The FDA approved the use of Botox Cosmetic on April 15th of 2002
according to this FDA
press release. BOTOX® was approved to treat two eye muscle disorders
in December of 1989.
FDA APPROVES BOTOX® TO TREAT FROWN LINES
FDA today announced the approval of Botulinum Toxin Type A (Botox
Cosmetic) to temporarily improve the appearance of moderate to severe
frown lines between the eyebrows (glabellar lines), a medical condition
that is not serious. The product's manufacturer, Allergan, Inc.,
Irvine, California, is now allowed to market Botulinum Toxin Type
A for this new indication.
Botulinum Toxin Type A is a protein produced by the bacterium
Clostridium botulinum. When used in medical settings as an injectable
form of sterile, purified botulinum toxin, small doses of the
toxin are injected into the affected muscles and block the release
of the chemical acetylcholine that would otherwise signal the
muscle to contract. The toxin thus paralyzes or weakens the injected
muscle.
BOTOX® was first approved in December 1989, to treat two eye muscle
disorders (blepharospasm and strabismus) and in December 2000
to treat cervical dystonia, a neurological movement disorder causing
severe neck and shoulder contractions.
In placebo-controlled, multicenter, randomized clinical trials
involving a total of 405 patients with moderate to severe glabellar
lines who were injected with BOTOX® Cosmetic, data from both the
investigators' and the patients' ratings of the improvement of
the frown lines were evaluated. After 30 days, the great majority
of investigators and patients rated frown lines as improved or
nonexistent. Very few patients in the placebo group saw similar
improvement.
In these studies, the severity of the glabellar lines was reduced
somewhat for up to 120 days for those patients who received BOTOX®
Cosmetic. Most of the patients in the study were female, and the
majority was under 50 years old. It is recommended that BOTOX®
Cosmetic be injected no more frequently than once every three
months, and the lowest effective dose should be used.
The most common adverse events following injection were headache,
respiratory infection, flu syndrome, blepharoptosis (droopy eyelids)
and nausea. Less frequent adverse reactions (less than 3% of patients)
included pain in the face, redness at the injection site and muscle
weakness. These reactions were generally temporary, but could
last several months.
Because BOTOX® Cosmetic is a prescription drug, it must be used
carefully under medical supervision.
|
