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Tuesday, July 20, 2004

FDA approves underarm Botox

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By

It might be just the thing for anxious politicians.

Just in time for the Democratic convention, the Food and Drug Administration has approved Botox injections to quell sweaty underarms that no antiperspirant can tame.

Botox, a prescription nerve blocker popularly used to ease facial wrinkles, came into political focus earlier this year when Sen. John Kerry emerged on the campaign trail with a newly smooth brow, causing some to wonder whether the Democratic presidential contender had taken a clandestine treatment or two.

The FDA approval of Botox to treat "primary axillary hyperhidrosis" -- or extremely sweaty armpits -- was announced yesterday, clearing the way for California-based manufacturer Allergan to market Botox "for this new indication."

Hollywood already knows all about the new indication, however.

Nervous starlets in designer gowns have minced down the red carpet on Oscar night in gem-studded shoes, serious foundation undergarments and "armpit Botox," according to press reports as far back as 2002.

"It costs $1,000 a treatment, but when you're wearing a $20,000 gown it's certainly worth it to stay dry," noted one dermatologist at the time.

The procedure -- which involves about 10 little sticks in the armpit -- was even offered by cosmetics manufacturer Estee Lauder in a mobile spa for the sweaty but glamorous elite.

"You don't need to wear deodorant," noted Dr. Karyn Grossman, who was part of the Estee Lauder team.

Botox as the ultimate sweat remedy has already been approved by regulatory authorities in Canada and a half-dozen European and South American countries, and has been in use for six years. German researchers revealed last year that Botox controls underarm odor because it paralyzes the common skin microbes that turn plain sweat into stink.

The substance also has been used to help those plagued with sweaty palms, feet and groin areas.

The Philadelphia-based International Hyperhidrosis Society praised the FDA's approval of Botox for "debilitating" underarm sweating, which affects the 8 million Americans who produce five times as much sweat as is considered normal -- marring their clothes, social moments and even career advancement.

"For primary axillary hyperhidrosis patients who have tried topical over-the-counter and prescription antiperspirant treatments without success, this is great news," said Dr. David M. Pariser, president of the group and secretary of the American Academy of Dermatology.

In the past, some desperate patients had underarm sweat glands removed by surgery or through liposuction. Others were misdiagnosed with an anxiety rather than a sweating disorder.

Botox simply deactivates nerves leading to sweat glands for up to eight months at a time. According to an FDA clinical trial of 600 adults, excess sweating was cut in half in 91 percent of them.

Allergan considers the new approval "another milestone."

The manufacturer expects to sell $700 million of Botox this year. The drug -- derived from the botulinum food toxin -- also has FDA approval for treatment of wrinkles and certain severe face and neck spasms.

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