BOTOX® Cosmetic Migraine Headaches

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BOTOX® Cosmetic: A Look at Looking Good
(July-August 2002, FDA Consumer Magazine - Excerpt)

BOTOX® 'Parties'
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.

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.

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