FDA On Botox

Botox Cosmetic: A Look at Looking Good
The promise of a more youthful look was too tempting for 53-year-old Mary Schwallenberg to pass up. So, when the Food and Drug Administration approved a product that temporarily improves the appearance of frown lines between the eyebrows, the Orlando, Fla., resident took a shot at it. And it wasn't long before she became one of many people clamoring for regular treatments that often include refreshments and friendly conversation, as well as injections.

Botulinum Toxin Type A (Botox Cosmetic) is a protein complex produced by the bacterium Clostridium botulinum, which contains the same toxin that causes food poisoning. When used in a medical setting as an injectable form of sterile, purified botulinum toxin, small doses block the release of a chemical called acetylcholine by nerve cells that signal muscle contraction. By selectively interfering with the underlying muscles' ability to contract, existing frown lines are smoothed out and, in most cases, are nearly invisible in a week.

Botox injections are the fastest-growing cosmetic procedure in the industry, according to the American Society for Aesthetic Plastic Surgery (ASAPS). In 2001, more than 1.6 million people received injections, an increase of 46 percent over the previous year. More popular than breast enhancement surgery and a potential blockbuster, Botox is regarded by some as the ultimate fountain of youth.

Schwallenberg, a pharmaceutical sales representative who is excited about her next round of injections, says she wants to look her best for her job. "That's corporate America for you," she says. "I have a lot of energy and I just wanted to look good."

Botox was first approved in 1989 to treat two eye muscle disorders--uncontrollable blinking (blepharospasm) and misaligned eyes (strabismus). In 2000, the toxin was approved to treat a neurological movement disorder that causes severe neck and shoulder contractions, known as cervical dystonia. As an unusual side effect of the eye disorder treatment, doctors observed that Botox softened the vertical frown (glabellar) lines between the eyebrows that tend to make people look tired, angry or displeased. But until this improvement was actually demonstrated in clinical studies, Allergan Inc., of Irvine, Calif., was prohibited from making this claim for the product.

By April 2002, the FDA was satisfied by its review of studies indicating that Botox reduced the severity of frown lines for up to 120 days. The agency then granted approval to use the drug for this condition.