FDA okays Botox to ease wrinkles, again and again
By WES ALLISON, Times Staff Writer
For nearly a decade, doctors have used tiny amounts of botulism to erase facial wrinkles and frown lines.
On Monday, the government said it was okay.
The U.S. Food and Drug Administration approved Botox injections for cosmetic purposes, setting up a national advertising campaign by the drug's manufacturer and likely making the expensive but temporary treatment an option for hundreds of thousands of more people.
Pharmaceutical analysts and the manufacturer, Allergan Inc., believe the product has tapped just one-tenth of the likely U.S. market. The company plans to launch a TV and magazine ad campaign in about two months, and analysts expect sales of Botox to rise by 30 percent this year alone.
That will mean good news, too, for doctors who perform the procedure. The effect of Botox typically wears off in four to six months, meaning patients who like what they see will have to return to see it again. And again.
The average treatment costs $300 to $400. Insurance does not cover it.
"With . . . an aging population working in your favor, this is the premier vanity product," said Tim Chiang, a specialty drug analyst for Banc of America Securities. "Now that they have the formal indication . . . they can formally market to the dermatologist, to the cosmetic surgeon, they can market the product to the average American."
Monday's action is a clear example of the market outpacing the regulators. Last year in America, there were 1.6-million Botox injections for cosmetic treatment, a 20-fold increase since 1997, according to the American Society of Aesthetic Plastic Surgery.
"I consider it the best little trick that there is in cosmetic surgery. It's a neat way to kind of postpone the inevitable," said Dr. Edward Farrior, a facial, plastic and reconstructive surgeon in South Tampa who has been using Botox for almost seven years.
The drug, available by prescription only, will be marketed as Botox Cosmetic. It's Allergan's brand-name for the botulinum toxin A, a purified form of the deadly botulism bacteria.
Botox was approved first in 1989 for the treatment of two serious muscle disorders of the eye, blepharospasm, which causes uncontrolled blinking, and strabismus, which causes the eyes to cross or wander.
But it wasn't long before doctors began using its deadening properties to relax frown lines and wrinkles, pitching it to affluent baby boomers as a quick, easy route to smoother skin. It has become widly popular in some quarters, including Hollywood. Doctors say the typical customer is a middle-aged woman with disposable income.
Dr. Diana Calderone, a Lutz dermatologist and clinical assistant professor at the University of South Florida School of Medicine, does about 10 Botox procedures each week. She's also one of her own best patients.
"I don't partake of many things I do for patients, like chemical peels or laser resurfacing, but Botox, I love it," Calderone, 38, said. "It makes a big difference. I don't have a lot of sun-induced aging, but I have a lot of expression lines, and with Botox they completely go away."
The lines develop over time, typically around the eyes, along the brow or forehead, and around the mouth.
Botox is a neurotoxin. It works not by damaging the muscles, but by blocking the instructions that make them contract. To treat them, doctors use a tiny needle -- about the diameter of a single hair -- to inject small amounts of Botox into those muscles. That causes them to go slack.
"Basically, any line that's in the face that's caused by a muscle contraction can be improved with Botox," said Dr. John Carthy of Tampa Laser Center, who has offered Botox for about five years.
FDA approval means it's generally safe and effective. In a study of 405 people with moderate to severe frown lines, Botox Cosmetic rendered the lines improved or non-existent in the "great majority" of patients, the FDA said.
In most cases, the effect became apparent within two days of treatment and lasted about four months.
The FDA reported no major risks or adverse incidents, but said the treatment is not without minor risks. The most common side effects were headache, flulike symptoms, nausea and droopy eyelids. Less than 3 percent of patients suffered pain in the face, redness at the injection site and muscle weakness.
The reactions were temporary, but could last up to several months, the agency said.
Botox is Allergan's top-selling product, accounting for $310-million in sales last year, or 18 percent of the company's revenue.
This year, thanks to the FDA approval, the company expects Botox sales to reach up to $420-million, Allergan spokeswoman Christine Cassiano said. The company's stock (NYSE: AGN) closed up 6 percent Monday, at $65.71 per share.
In 2000, Botox was approved for cervical dystonia, which causes involuntary movement of the neck and shoulders. It also is in final clinical trials for excessive sweating and the spasticity that can occur after stroke.
Doctors can prescribe drugs for unsanctioned uses, but the manufacturers cannot advertise for those uses without FDA approval. Allergan sought FDA approval for cosmetic purposes in January 2001. Monday's decision means the company may hold informational and training seminars for doctors, likely making its use more widespread. It also should help win over some potential patients who have been afraid to try it, analysts and doctors said.
Tampa Bay area doctors say the biggest downsides are the drug's high cost and its passing nature. But because the effect is temporary, any unforeseen or disappointing consequences also disappear.
"If you don't like the fact that you can't scowl at your children anymore to scare them, then it goes away," Farrior said.
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