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From Deadly Poison to Solution for Sagging Skin

Botox expected to get FDA approval soon as a wrinkle fighter

FRIDAY, Feb. 8, 2002 (HealthDayNews) -- In the movie "Sleeper," Woody Allen wakes up after a few hundred years to a world in which he's told that cigarettes are good for him.

That's too much of a stretch, but there appears to be some truth to findings that substances long believed to be bad in large doses can be quite beneficial in controlled situations.

The latest example is Botox, embraced by many of the rich and famous as a way to smooth the lines from their faces. This injectable form of a deadly poison is about to have a few of its own wrinkles ironed out.

Although Botox has been used as a cosmetic treatment since the early 1990s, Botox has never had federal government approval for use as a wrinkle fighter.

Now, it's about the get the official nod. The U.S. Food and Drug Administration (FDA) will soon approve Botox for cosmetic use, according to a number of news reports, including a story in the New York Times.

Botox is manufactured by Allergan Inc. of Irvine, Calif. Christine Cassiano, manager of media relations for Allergan, says the company expects the FDA approval by the end of March. The company filed for approval in January 2000 and submitted clinical trials to the FDA for review.

Botox is the commercial name for botulinum toxin type A. In high doses, this toxin causes botulism and leads to serious and often fatal paralysis in people who have eaten food contaminated with it.

Yet, in 1989, the FDA approved Botox to treat eye muscle spasms. It was later approved to treat cervical dystonia, a neurological movement disorder where muscle contractions force the head and neck into abnormal and sometimes painful positions.

How could such a potent poison become so helpful?

Dermatologists and plastic surgeons noted the effect Botox had in relaxing facial muscles. So they began using it to treat wrinkles lines around the eyes and forehead, says Dr. Harold Brody, an Atlanta-based dermatologic surgeon and past president of the American Society for Dermatologic Surgery.

Botox is administered in minute quantities. It blocks nerve signals to tiny facial muscles responsible for expression lines caused by frowning, smiling, laughing and squinting. The muscles can't contract and so they remain relaxed, leaving a smoother-looking face.

Brody says Botox, which must be administered by a physician or under a physician's direct supervision, is effective and safe.

In some cases patients may have bruising, stinging or redness around the injection sites. Patients may experience a droopy eyelid, but only if Botox is used improperly, Brody says.

Patients have to refrain from bending over or lying down for four to six hours after treatment to prevent the toxin from seeping into other muscles. Botox treatments, which can cost between $300 and $2,000, need to be repeated every three to six months.

Even though Botox didn't have FDA approval for cosmetic treatment, dermatologists and plastic surgeons using it to treat wrinkles weren't doing anything wrong, Brody says.

It's called off-label use.

"It's acceptable in medicine for physicians to use a drug which is FDA-approved for one use or indication and use it for another indication or use," Brody says.

So what's the advantage of formal FDA approval of Botox for cosmetic use?

It will permit its manufacturer, Allergan, to advertise and promote Botox specifically for wrinkle treatment - something the company couldn't do before - and will also lead to more consumer awareness and use of Botox, Brody says.

"Now more people will realize that this is like a home run on your face. It's a fabulous addition that dermatologists can use to combine with the other rejuvenation methods that we have," Brody says.

Allergan isn't saying how large an impact the FDA approval will have on Botox sales.

"Obviously it's something we have been working years to achieve, with all the clinical trials and filings, and it's something we anticipate will be very good for the company because it will give us the opportunity, when we get that approval, to speak to a use that people have been using off-label," Cassiano says.

What to Do: Here's where to go to get more information about Botox. And here's an FDA site all about botulinum toxin.

SOURCES: Interviews with Harold Brody, M.D., dermatologic surgeon, Atlanta, Ga.; Christine Cassiano, manager of public relations, Allergan Inc., Irvine, Calif.
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