Botox Cosmetic : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Scott A. Greenberg, M.D., a board-certified plastic surgeon in Winter Park, Fla., has been hosting monthly "Botox Happy Hours" in his medical office since the drug's approval in April. Greenberg feels that these by-invitation-only events to previous patients "are an opportunity to treat a lot of people at one time in a relaxed but professional atmosphere." Greenberg says there is no difference between treating 10 people during individual office visits throughout the day and treating 10 people individually, but in a more socialized setting. "The important thing is that the identical standards of medical care are maintained at these gatherings as in a routine daytime office consultation."

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.

"We lose something when we mass treat," says Franklin L. DiSpaltro, M.D., president of the ASAPS. "One of my concerns is that these parties are a marketing tool — gathering as many patients as possible trivializes a medical treatment, which could deteriorate over time into a nonprofessional environment." DiSpaltro says there's more to medicine "than just dispensing drugs."

Schwallenberg, however, insists that "Dr. Greenberg was very professional. It wasn't a cattle call," she says. "And I don't think I'd go to a doctor I didn't know."

The FDA is concerned that Botox has the potential for being abused. The ASAPS recently reported that unqualified people are dispensing Botox in salons, gyms, hotel rooms, home-based offices, and other retail venues. In such cases, people run the risks of improper technique, inappropriate dosages, and unsanitary conditions. "Botox is a prescription drug that should be administered by a qualified physician in an appropriate medical setting," says Toombs.

Greenberg agrees. "Patient safety has to be of prime concern," he says. "People need to be in the right hands when complications arise." That's why Greenberg does not allow his staff to administer Botox treatments. Even the most skilled health-care providers, he says, can have complications as well as dissatisfied customers.

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.