February 12, 2008 Hello! More and more people (of all ages) are considering Botox® treatment as an "easy" way to get the look they want without the dangers of a more invasive surgery. For some, this raises concerns. Just a couple weeks ago it was reported that:
"A consumer group, Public Citizen, is lobbying U.S.
authorities to strengthen the health warning on Botox and
its kin, Myobloc. They want to see a 'black box' warning --
similar to the health caveat plastered on cigarettes --
adhered to containers of the substances. ...[T]he group
studied 180 reports submitted to the FDA and noted that in
the 16 deaths caused by Botox, four of those fatalities
occurred in patients under 18. ... According to the
[American Society of Plastic Surgeons'] 2006 statistics,
22,795 Botox injections were given to teenagers. (The ASPS
tallies injections, rather than patients.)" According to the FDA (Food and Drug Administration), Botox® is:
"Botulinum Toxin Type A (Botox Cosmetic) is a protein
complex produced by the bacterium Clostridium botulinum,
which contains the same toxin that causes food poisoning.
When used in a medical setting as an injectable form of
sterile, purified botulinum toxin, small doses block the
release of a chemical called acetylcholine by nerve cells
that signal muscle contraction. By selectively interfering
with the underlying muscles' ability to contract, existing
frown lines are smoothed out and, in most cases, are nearly
invisible in a week." The reason Botox® works is because the muscles into which it is injected are paralyzed by the botulism toxin.
"Botulism is a rare but serious paralytic illness caused by
a nerve toxin that is produced by the bacterium Clostridium
botulinum. There are three main kinds of botulism.
Foodborne botulism is caused by eating foods that contain
the botulism toxin. Wound botulism is caused by toxin
produced from a wound infected with Clostridium botulinum.
Infant botulism is caused by consuming the spores of the
botulinum bacteria, which then grow in the intestines and
release toxin. All forms of botulism can be fatal and are
considered medical emergencies. Foodborne botulism can be
especially dangerous because many people can be poisoned by
eating a contaminated food." While the toxin produced by Clostridium botulinum can cause botulism, the FDA ruled Botox® to be safe because of the small quantities of the toxin being used and because of the location into which it was being injected.
"Although there is no chance of contracting botulism from
Botox injections, there are some risks associated with the
procedure. If too much toxin is injected, for example, or
if it is injected into the wrong facial area, a person can
end up with droopy eyelid muscles (ptosis) that could last
for weeks. This particular complication was observed in
clinical trials. Other common side effects following
injection were headache, respiratory infection, flu
syndrome, and nausea. Less frequent adverse reactions
included pain in the face, redness at the injection site,
and muscle weakness. These reactions were generally
temporary, but could last several months. While the effects
of Botox Cosmetic don't last, still, people don't seem to
mind repeating the procedure every four to six months in
order to maintain a wrinkle-free look. Battling the signs
of aging in a non-invasive way, after all, is part of the
allure of the product--that and the fact that there are no
unsightly scars, and that there is very little recovery
time with the procedure. The FDA recommends that Botox
Cosmetic be injected no more frequently than once every
three months, and that the lowest effective dose should be
used." By 2004, reports of lawsuits and problems with injected botulism toxin had made the news:
"Investigators working with the Centers for Disease Control
and Prevention have determined what caused the paralysis in
four people who received Botox injections at a South
Florida clinic. For two weeks, health officials have feared
that four patients who received the injections were
suffering from botulism. Tuesday, the Florida Department of
Health confirmed three of four patients who became ill
tested positive for botulism. ... Investigators say an
unregulated vial of Botox could contain more toxin than
indicated on the label, which could lead to botulism. State
health officials say they have an ongoing battle to root
out such activity and they hope to learn more about this
case with the help of the patients being treated for
botulism. ... Health officials say botulism patients can be
paralyzed for up to a year until the toxins are flushed
from their systems." When those giving the injections opt for unregulated products, or products are used for off-label treatments, the chance of a possible adverse reaction increases. Once again, botulinum toxin injections have made the news.
"Botulinum toxin injections, best known for smoothing
wrinkles, have been linked to cases of serious reactions,
including death, the Food and Drug Administration announced
Friday. ... Most of the severe reactions occurred in
children treated for limb spasticity associated with
cerebral palsy, an off-label use, [Russell Katz, director
of the neurology products division at the FDA's Center for
Drug Evaluation and Research] said. Such off-label uses are
appropriate if the physician believes they are, Katz said.
Questions of the Week: Please email me with any ideas or suggestions. I look forward to reading what you have to say. Cindy |
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