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FDA Approval of Botox a Blessing and Curse

Doctors urge consumers to choose a qualified physician

FRIDAY, Oct. 25, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration's approval of Botox for cosmetic use has been both a blessing and a curse for those yearning to smooth their wrinkled brows.

Predictably, it has led to a surge in the number of people seeking the trendy treatments, dermatologists say.

At the same time, doctors are also seeing an increase in the number of people suffering complications from Botox injections. While they have no proof, the dermatologists suspect these problems may be the results of treatments performed by unqualified people.

A group of doctors shared their concerns at a panel discussion this week in New York City. The session was one of two sponsored by the American Academy of Dermatology to report on the latest research in dermatological treatments for both medical and cosmetic procedures.

"People have a sense of false security [about Botox] because of the FDA approval, and it seems more likely to be used by non-trained administrators," said panelist Dr. Patricia K. Farris, a professor at the Tulane University School of Medicine in New Orleans.

While there are always risks from any medical procedure, said fellow panelist Dr. Bruce E. Katz, a New York City dermatologist, he has noticed an increase in patients coming in with complications from Botox injections. Problems include eyes that droop and what he called "witch's eye," when one eyebrow is higher than the other.

"The success of the procedure is very technique-dependent. It depends on who's using the needle," said Dr. Frederic S. Brandt, a professor in the department of dermatology at the University of Miami School of Medicine who was the keynote speaker on the topic of Botox.

He said that whoever performs the procedure, which consists of paralyzing muscles at the brow line with four injections of the purified toxin so that patients can't frown, must have a thorough knowledge of anatomy so he or she knows exactly where to inject the Botox.

"This is not the kind of procedure that should be done in a home setting or where alcohol is being served," Brandt said, referring to reports of so-called Botox cocktail parties where people gather and have the injections.

Botox is the brand name for a purified version of a bacterium called clostridium botulinum. First approved in 1989 to treat two eye muscle disorders, it has since been approved to treat a disorder causing severe neck and shoulder contractions. In April, the FDA approved its use to reduce worry lines between the eyes.

While there are several types of the bacteria, it is one type -- botulinum toxin type A -- that received the FDA approval for cosmetic treatments. Brand called it the "gold standard."

In the procedure, which takes a few minutes, small doses of botulinum are injected into the brow muscles responsible for the frown lines. The toxin binds to the nerve endings, blocking the release of the chemical acetylcholine, which would otherwise signal the muscles to contract. The toxin then paralyzes the muscles, and they remain in this paralyzed position for three to four months.

Someone who previously squinted their eyebrows together can no longer do so, and the result is a smoother brow line. The most common side effects are related to the procedure itself and include redness, swelling, mild pain and some bruising at the site of the injections.

Katz recommends that patients seeking Botox injections go to properly trained doctors.

"Ask the doctor how much experience he has," Katz said, because a doctor who does it often will be the most proficient.

What To Do

You can read about the FDA approval of botulinum for frown lines by clicking here. If you're thinking about having Botox injections, visit The American Society for Aesthetic Plastic Surgery for guidelines to follow before you agree to the procedure. For more on Botox injections, check with the American Academy of Dermatology.

SOURCES: Frederic S. Brandt, M.D., clinical associate professor, dermatology, University of Miami School of Medicine; Patricia K. Farris, M.D., clinical assistant professor, Tulane University School of Medicine, New Orleans; Bruce E. Katz, M.D., associate clinical professor, dermatology, College of Physicians and Surgeons, Columbia University, New York City
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