Botox, What the FDA Wants You To Know

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.

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 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.

Ella L. Toombs, M.D., a dermatologic medical officer in the FDA's Office of Cosmetics and Colors, says, "Careful deliberation, investigation and evaluation is undertaken by the agency before any prescription product is approved." Drugs such as Botox, which are not indicated for serious or life-threatening conditions, "are subject to a greater level of scrutiny because of the benefit-to-risk ratio." Toombs says this means that the FDA may allow someone to incur a greater risk from products that treat medical conditions, rather than from those that are approved for cosmetic purposes.

Botox 'Parties'

The recent rise in the popularity of Botox has much to do with the manner in which it is frequently marketed. Some practitioners buy the toxin in bulk and arrange get-togethers for people receiving their treatments. As in business, volume discounts can be found in medicine.

Plastic surgery events known as Botox parties--also seminars, evenings and socials--are a key element of Botox marketing in much of the United States. The gatherings are thought to be a convenient means of providing Botox treatments more economically, and may help reduce the anxiety that normally goes along with getting an injection. Doctors are finding that treating people in groups allows them to make the procedure more affordable to their patients.

Here's how a "party" typically works: A group of often nervous, but excited, middle-aged men and women mingle in a common area. Sometimes refreshments are served. One by one, as their name is called, each slips away for about 15 minutes to a private exam room. He or she pays a fee and signs an informed consent agreement. Anesthesia is rarely needed, but sedatives and numbing agents may be available. The practitioner injects about one-tenth of a teaspoon of toxin into specific muscles of the forehead most often targeted for the effect. The person then rejoins the group.

Julianne Clifford, Ph.D., of the FDA's Division of Vaccines and Related Products Applications, explains that "Botox is licensed for marketing and distribution as single-use vials." This means that as packaged, "each vial is intended to be used for a single patient in a single treatment session." Botox does not contain a preservative against potential contamination of the product through repeated use of a single vial. Once opened and diluted, Botox must be used within four hours. Treating multiple people with one vial violates product labeling, which is stated on the package insert, the vial and the carton.


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