Botox, the popular drug that temporarily removes "frown lines" and other wrinkles, was formally approved Monday by the Food and Drug Administration for cosmetic use. The ruling will allow its manufacturer to start an advertising campaign to convince Americans they can look younger and less worried with a few small injections.
Not since the male sexual dysfunction drug Viagra was approved has a drug attracted as much attention, or so quickly become part of the popular culture. With more than 1.6 million procedures performed in the United States last year, some are already talking of the "Botox nation."
"It seems to me this thing is going up and up, as people look for quicker, simpler and less invasive ways to hold the fort against the ravages of age," said Daniel Morello, past president of the American Society for Aesthetic Plastic Surgery. "Botox has been used off label for years, but this approval will make it appealing to a large, new group of Americans."
Botox is a purified form of the toxin that causes botulism, and has been on the market as a drug to treat several muscle disorders of the face since 1989. But in recent years, cosmetic surgeons have also been commonly using the drug to remove frown and wrinkle lines by temporarily paralyzing -- and thereby relaxing -- facial muscles.
The American Society for Aesthetic Plastic Surgery listed Botox injections as the fastest growing cosmetic treatment performed by surgeons in the United States in its 2001 national statistics.
While Botox is already used by doctors to remove lines of all kinds, the FDA approval is specifically for frown lines between the eyebrows. The agency reported that in clinical trials of 405 people, mostly women, Botox noticeably erased the lines. "The great majority of investigators and patients rated frown lines as improved or nonexistent," the FDA reported. "Very few patients in the placebo group saw similar improvement."
The maker of Botox, Allergan Inc. of Irvine, Calif., said that it will begin marketing the product as Botox Cosmetic to doctors and directly to consumers.
Analysts who follow the specialty pharmaceutical industries are predicting that sales will jump quickly. According to Gregg Gilbert at Merrill Lynch & Co., Botox sales will be $397 million this year, but should reach $668 million by 2005.
"Botox has been very successful through simple word-of-mouth," Gilbert said. "Now they can advertise, and that should drive sales up quickly."
Some observers do not think this is necessarily a good thing. Rita Freedman, a psychologist in Harrison, N.Y., said the Botox phenomenon reflects a national fear of age and death -- a reluctance to face the realities of life.
"There is growing evidence that despite more and more procedures to make us look better, there is less and less satisfaction with our bodies," she said. "Advertising is driving us to spend our money and time on the emotionally limited issue of how we look to others."
But Cheryl Burgess, a dermatologist in the District who has been providing Botox treatment for several years, said her patients have been very pleased. The biggest problem, she said, has been that patients want to have injections -- which cost $500 to $800 for a full upper face treatment -- sooner than they should.
"Many people in this town have stressful jobs that cause a lot of frowning and muscle contracting in the face," Burgess said. "They come here and can lose those wrinkles, and they like what they see enormously."
She said the treatment has been equally popular with men and women in Washington -- although nationally, women are far more likely to use Botox -- and that users are most typically in their 40s. Burgess said the treatment has a particularly strong following among Asian-Americans, most likely because it has been widely used in Japan and China for years. Botox is made from the botulinum toxin type A, a protein produced by the bacteria Clostridium botulinum . Doctors and cosmetic surgeons inject small doses of the toxin into the affected muscles, and they block the release of a chemical that would otherwise signal the muscle to contract. The toxin thus paralyzes or weakens the injected muscle. According to Allergan, the treatment usually begins to work within 24 to 48 hours, and can last up to four months.
The drug can cause minor side effects such as headache, nausea and flu symptoms. Less than 3 percent of people also study experience face pain, redness at the injection site and muscle weakness. Those side effects were generally temporary but could last several months, the FDA warned.
In a statement released after the FDA approval, the company described how it planned to promote the drug. It quoted Jennifer Luner, a 49-year-old business consultant, as saying that before she tried a Botox treatment, her friends and colleagues often thought she was upset or worried, even if she wasn't. "After the treatment, my friends told me I looked so much more refreshed and approachable."
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