| Botox Cosmetic |
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| 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. Botox injections are the fastest-growing cosmetic procedure in the industry, according to the American Society for Aesthetic Plastic Surgery (ASAPS). In 2001, more than 1.6 million people received injections, an increase of 46 percent over the previous year. More popular than breast enhancement surgery and a potential blockbuster, Botox is regarded by some as the ultimate fountain of youth. Botox was first approved in 1989 to treat two eye muscle disorders--uncontrollable blinking (blepharospasm) and misaligned eyes (strabismus). In 2000, the toxin was approved to treat a neurological movement disorder that causes severe neck and shoulder contractions, known as cervical dystonia. As an unusual side effect of the eye disorder treatment, doctors observed that Botox softened the vertical frown (glabellar) lines between the eyebrows that tend to make people look tired, angry or displeased. But until this improvement was actually demonstrated in clinical studies, Allergan Inc., of Irvine, Calif., was prohibited from making this claim for the product. By April 2002, the FDA was satisfied by its review of studies indicating that Botox reduced the severity of frown lines for up to 120 days. The agency then granted approval to use the drug for this condition. The FDA regulates products, but not how they are used. Approved products are sometimes used by a licensed practitioner for uses other than those stated in the product label. Botox Cosmetic, for example, is currently being used by physicians to treat facial wrinkles other than those specified by the FDA. Consumers should be aware, however, that this "off-label" use has not been independently reviewed by the agency, and the safety and effectiveness of Botox injections into other regions of the face and neck, alone or in combination with the frown-lines region, have not been clinically evaluated. If you are considering Botox Cosmetic, keep the following things in mind: • Be sure that a qualified doctor performs the procedure. • Make sure that the doctor is trained and qualified in cosmetic skin surgery of the face. • Ask questions and be informed about the benefits and risks involved in the procedure. • Avoid alcohol and remain upright for several hours following the procedure. • Choose a medical setting using sterile techniques. Necessary equipment should be available to respond to any potential problems. 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. For more detailed information about Botox Cosmetic, ask your health care provider. Source: United States Food and Drug Administration |
| This fact sheet
provides details on how Botox Cosmetic (Botulinum Toxin Type A) is used by
cosmetic surgeons in reducing the visible signs of aging, such as wrinkles
and "frown lines." |
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| This document is
provided solely for educational and informational purposes. Be sure to consult your doctor before making any major medical decision. |
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