Botox, a wrinkle-smoothing drug popularized by an aging baby-boom generation for use as plastic surgery in a bottle, received Food and Drug Administration approval Monday for use in over-the-counter cosmetic products.
Previously reserved for the offices of medical practitioners such as dermatologists or plastic surgeons, the approval now allows the drug’s producer, Allergan Inc., to advertise the product directly to consumers.
Even without the benefit of advertising, Botox — made effective by the bacteria responsible for botulism — has emerged as a kind of cult phenomenon amongst those seeking to reverse the effects of aging.
“The FDA’s approval is an important accomplishment. Our successful clinical work shows that Botox Cosmetic is safe and effective for this aesthetic use,” said Lester J. Kaplan, Ph.D., Allergan’s president of research and development.
Facial furrows form mainly in response to normal aging as well as sun exposure and the pull of underlying muscles. Botox works by decreasing the pull of these muscles. This allows treatment of some skin creases without surgery.
Treatments cost approximately $400 dollars and the effects tend to last for about three months.
However, physicians say the active substance in the drug is itself quite dangerous.
“The bacteria, called botulinum, is very deadly; it is the type of thing that caused your mother to warn you not to eat out of cans that were bulging,” said Dr. Scott Spear, director of University Health Services. “It’s an organism that grows anaerobically — that’s why it grows in cans. It works by paralyzing muscles; therefore, in quantity, it can kill.”
He further explained how the drug functions in cosmetics.
“The drug works by taking a very small amount and sending it beneath the skin,” Spear said. “Muscles keep the skin under tension, so when the muscles are paralyzed, the wrinkles relax.”
The FDA report on Botox acknowledges some risks have been uncovered in clinical trials of the drug.
“The most common adverse events following injection were headache, respiratory infection, flu syndrome, blepharoptosis [droopy eyelids] and nausea,” the report reads. “Less frequent adverse reactions [found in less than three percent of the patients] included pain in the face, redness at the injection site and muscle weakness.”
Dr. Kevin Robertson, a Madison plastic surgeon with extensive experience in using Botox for cosmetic procedures, said it has a host of other medical uses.
“There is a history of uses, such as on hyper-functional muscles — cosmetically, that means things like wrinkles in the forehead and around the eyes,” he said. “It can also be used for a condition called hyper hydrosis, which involves excessive sweating.”
Robertson said the cosmetic procedure is common and that he performs it frequently.
“It’s very popular for smaller, more confined or easily healable types of procedures,” he said. “It’s a ‘lunchtime’ type of procedure. The affect kicks in [after] about three days and lasts for a few months.”
Robertson said he performs as many as 25 to 50 procedures a month.
Despite an average cost of about $400 for each treatment, use of such drugs grew 46 percent between 2000 and 2001 and 2,356 percent between 1997 and 2001, according to the organization’s figures. Sales of Botox increased from $25.3 million in 1993 to $309.5 million in 2001.
However, despite its popularity, Spear said the use of cosmetic Botox may have additional tradeoffs.
“One of my colleagues from high school is now a plastic surgeon. For our 30-year reunion, she did it to herself,” he said. “She looked great, but she probably couldn’t furrow her brow if she wanted to.”
