FDA Smooths the Way for the Cosmetic Use of Botox

WASHINGTON â€”  The U.S. Food and Drug Administration, catching up with Americans’ quest for youthful beauty, approved the use of Botox on Monday to reduce the appearance of wrinkles.

Last year alone, more than 855,000 people received injections of botulinum toxin type A, as Botox is formally known, to smooth out frown lines, forehead creases, crow’s feet and neck bands. Many patients also get refresher injections when the effects of the original shot wear off after three to six months.

Plastic surgeons hailed the FDA’s approval of Botox for cosmetic use, saying it would give doctors and patients more confidence.

The approval “provides reassurance to both patients and physicians that it’s an OK product in terms of safety and efficacy,� said Dr. James Wells, a Long Beach plastic surgeon and president-elect of the American Society of Plastic Surgeons.

Dr. Glynis Ablon, a dermatologist and cosmetic surgeon in Manhattan Beach, said that thousands of Californians are already lining up for Botox injections to smooth wrinkles.

“Actors, actresses, housewives, husbands, lawyers: people from age 20 all the way up to age 80,� she said. She expects the FDA action to create a wave of advertising and price wars--perhaps knocking hundreds of dollars off the $350 to $700 price tag for a round of injections--and launch the procedure into the mainstream.

The FDA first approved Botox, a byproduct of the bacteria that causes botulism, in 1989 for the treatment of two eye-muscle disorders. In 2000, it said the toxin could also be used to treat a disorder that causes neck and shoulder spasms.

But because federal law allows physicians to use approved drugs for unapproved purposes “as they deem appropriate,� doctors a few years ago began injecting Botox into facial muscles to reduce or eliminate wrinkles. “We don’t regulate the practice of medicine,� said FDA spokesman Jason Brodsky.

Maker Celebrates Potential Windfall

For officials at Irvine-based manufacturer Allergan, which asked the FDA early last year to authorize Botox for cosmetic use, Monday’s approval launched celebrations of an anticipated windfall.

“We’re thrilled,� said Christine Cassiano, Allergan’s manager of public affairs. Allergan’s stock rose $3.80 to $65.71 in Monday’s trading.

Botox generated 18% of the company’s sales revenue last year, about $310 million, and with the new FDA approval sales this year could total $385 million to $420 million, Cassiano said. The company will spend about $50 million this year to tout the line-erasing properties of the product, which it has renamed Botox Cosmetic, she said.

Company officials say the drug is particularly effective at temporarily getting rid of the vertical lines that can develop between the eyebrows.

“I don’t have that ‘11’ between my eyes anymore,� said Patricia Reimerdes, a 50-year-old New York mother of two who got a Botox injection in February. “I love it.�

Reimerdes conceded that the injection has also left her unable to raise her eyebrows.

“But that’s OK,� she said, adding that she will “definitely� have the procedure done again when the effects of her first injection fade away.

Indeed, the creation of an expressionless, zombie-like face is among the treatment’s more notorious side effects, which also include headaches, respiratory infection, droopy eyelids and nausea, according to the FDA.

“I tend to like facial expression, myself,� said Wells, the plastic surgeon in Long Beach, but Botox does “soften the aging process.�

Among the other surreal Botox effects Wells has seen or read about are a permanent quizzical look and an equally fixed “witch-like� look. Then there was one of his own patients, Wells recalled, who had trouble pursing her lips around a straw after he injected too much Botox in the lines around her mouth.

The Lure of Botox’s ‘Quick Fix’ Cited

Despite the risks, Wells believes the convenience and “quick fix� aspect of Botox injections will make the treatment increasingly popular among baby boomers who are beginning to despair as they see the lines in the mirror.

Botox injections can be administered in five minutes to 15 minutes per wrinkle area, and the benefits are evident in a couple of days, Wells said.

And for many people seeking to erase the marks of time, a Botox injection, which averages $400 per area, is far more affordable than a face-lift, which would set them back thousands of dollars.

Injections Popular Among 35-Plus Crowd

According to a survey commissioned by the American Society of Plastic Surgeons, 55% of the 855,846 people who received Botox injections last year were ages 35 to 50.

Botox injections accounted for 15% of all nonsurgical cosmetic procedures performed last year. Other popular cosmetic treatments or plastic surgeries include chemical peels, liposuction, eyelid surgery, face-lifts and breast augmentation.

In Southern California, ever ahead of the curve on facial-line elimination, doctors say the cosmetically enhanced have already moved on to the next big Botox thing: underarm injections of the drug to stop perspiration--for a while.

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Times staff writer Benedict Carey contributed to this report.