Botox awaits FDA approval

The Associated Press
Monday April 01, 2002

LOS ANGELES — Not since the early days of Viagra has a lifestyle drug garnered so much attention as Botox. 

Botox has erased early wrinkles on young women, flattened the furrowed brows of middle-aged TV anchormen, removed sweat stains under the arms of runway models, and even erased gamblers’ unwanted facial expressions. 

In the process, the muscle-paralyzing substance has become one of the most profitable products for Allergan Inc., which first branded the drug more than a decade ago for treating crossed eyes. 

Botox is a laboratory refined strain of botulinum toxin — one of the most poisonous substances on earth — that’s given in extremely small therapeutic doses. Botulinum toxin causes botulism and is a favored tool of bioterrorists. The cult Aum Shinrikyo dispersed a strain of it in aerosol form in several failed attacks in Japan in the early 1990s. Botox already has regulatory approval to treat certain spasmic disorders. But it’s the drug’s wrinkle-busting properties that have created a national buzz. 

“I am getting to the point where the lines are a little more noticeable. (Botox) is an easy way to soften that change,” said Lisa J. Davis, a 30-something Los Angeles TV producer. 

Men and women of all ages have made Botox injections the most popular cosmetic medical procedure in the nation since 2000, even though the procedure may produce side effects such as swelling or numbness. The Food and Drug Administration has yet to approve the drug for cosmetic use, but the agency doesn’t prevent doctors from using it in this way.