BOTOX is strain of botulinum toxin — the same toxin that causes
botulism, the much-feared form of food poisoning. But injected in
purified, diluted amounts, it can safely paralyze unwanted muscle
movements — from crossed eyes to wrinkle-causing facial expressions.
After the drug was approved in 1989
for treating eyelid muscle spasms, doctors observed that Botox also
erased nearby wrinkles. And since it is legal for doctors to use a
prescription drug for other reasons — so-called off-label use —
doctors began offering the treatment to baby boomers seeking to unfurrow
their brows and eliminate crow’s feet.
But Allergan was forbidden from
encouraging such use.
Until now. On Monday, FDA cleared
Botox for its first cosmetic use — specifically, to temporarily
improve the appearance of moderate to severe frown lines, or furrows,
between the eyebrows. That means Allergan can now advertise these
wrinkle-busting properties to doctors and the general public.
“Our successful clinical work
shows that Botox Cosmetic is safe and effective for this aesthetic
use,” Lester J. Kaplan, Allergan’s president of research and
development, said in a statement. “This new indication firmly
establishes the versatility of the product.”
Industry analysts say the company
plans to spend more than $100 million on a Botox TV and print ad
campaign.
NO. 1 COSMETIC PROCEDURE
Even without advertisements,
word-of-mouth has already made Botox injections the No. 1 cosmetic
procedure in the nation — with 1.6 million procedures performed in
2001, according to the latest statistics from the American Society for
Aesthetic Plastic Surgery (ASAPS).
Doctors predict FDA approval will
propel the drug into superstar status. “When the FDA finally approves
something that’s been used off-label for a long time it brings
legitimacy and increases its use,” said Dr. Brian Kinney, a Los
Angeles plastic surgeon and ASAPS spokesperson. “I wouldn’t be
surprised if the publicity surrounding the stamp of approval caused the
market to double in the next few years.”
Dr. Fredric Brandt, a Miami
dermatologist who spends 80 percent of his work day injecting Botox,
says that while most people on the West and East Coasts are already
aware of the procedure, “the middle of the country will probably see a
big increase because the trend has been slower to pick up there.”
Brandt, who administers more Botox
than anyone else in the country, said patient satisfaction with the
procedure has been phenomenal. “In fact, I like it better than surgery
because it has a more natural effect,” he said.
PATIENT SATISFACTION
Kinney’s patient Kylie, a
personal assistant to an actor, gets Botox injections about twice a year
to eliminate the vertical crease between her eyebrows.
“It’s fantastic — it takes
five to 10 years off my face without surgery,” said Kylie, who asked
that her real name not be used. “In our family we all get that line
between the eyebrows. My sister and I got Botox and now it’s totally
gone on both of us.”
Kylie, who is in her late-30s, said
that the FDA’s approval doesn’t mean much to her. “It doesn’t
make me feel safer — I always thought it was pretty safe.”
Botox is most popular among such
women in the 35-50 crowd, which accounted for just over half of the
injections last year. But younger folks and men are also jumping on the
Botox bandwagon: Nearly 14 percent of the procedures were done on men
and almost 15 percent of recipients were under 34.
COSMETIC APPROVAL
Approval for the new cosmetic use
was based on clinical trials involving a total of 405 patients with
moderate to severe crease lines between the eyebrows who were injected
with Botox Cosmetic or placebo, according to the FDA.
After 30 days, the majority of
doctors and patients rated frown lines as improved or nonexistent in
patients given Botox. Very few patients in the placebo group saw similar
improvement.
HOW IT WORKS
A doctor injects Botox into the
facial muscles that cause wrinkling: In the case of brow furrow lines,
the corrugator and procerus muscles, two major muscles in the forehead,
are most often the target.
The toxin blocks the the
transmission of signals from the brain to the muscles, thereby
paralyzing the muscle and creating a smoothed appearance between the
brow.
In the case of other wrinkles such
as crow’s feet — which doctors will undoubtedly continue to perform
even as official FDA approval for those uses is awaited — the muscles
are different but it works the same way.
But the look does not last.
Injections have to be repeated every three to six months — at a cost
of $200 to $1,000 per treatment.
Doctors who perform the procedure
say it’s worth it.
“Botox
is the perfect example of drive-through medicine — you have it done
that afternoon and you look fine by that evening. It’s very safe —
it’s a winner on all those accounts,” Kinney said.
Patient Kylie agrees: “You go in
get it done and you’re in and out and can get on with your day, nobody
knows.”
In addition to its use in furrowed
eyebrows, Botox is most commonly used on foreheads and for crow’s
feet. But doctors are increasingly using Botox to smooth the lines in
the neck and lower face, such as the crease that runs from the nose to
the mouth, vertical lines above the lip and “marionette lines” that
run from the outside of the mouth down to the jaw.
Botox also has been shown to offer
relief from headache pain and prevent excessive sweating on the palms or
under the armpits. Allergan is also seeking approval to market the drug
for all these purposes.
POTENTIAL RISKS
Doctors agree that Botox is not
toxic — there’s no risk of contracting botulism poisoning — though
there can be swelling, numbness and bruising. And doctor error, either
poor aim or over-injection, is the biggest concern - as too much can
cause a frozen, expressionless face and poor aim can cause a droopy
eyelid. But like the good results, bad results fade within a few months.
Kinney says that while
patients are satisfied with the results, he doesn’t think Botox is the
ultimate solution to looking younger.
“The disadvantage in my view is
it’s anti-physiologic, by which I mean, it doesn’t make you look
like you did when you were 25. You didn’t look paralyzed when you were
25,” he said. “So Botox isn’t the final answer. I like it; it
works; it’s effective; it’s safe — but in the future I think
we’ll be looking to treatments that build muscle, skin and fat to make
your face look more like when you were younger.”
But for many devotees of Botox, the
biggest concern is that the injections will cease to work their magic.
About 5 percent of patients build antibodies to the toxin, which means
later shots won’t work.
“Botox is a beauty essential,”
said Kylie. “I won’t stop. Manicures, pedicure, waxing and Botox —
they’re all must-haves.”
Source: MSN Website Oct 9,
2002
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