Botox, What the FDA Wants You To Know (cont.)
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.
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.