Boon for Botox Injections Expected with FDA's Approval

Amy Fletcher  Business Journal Staff Reporter

A Denver plastic surgeon says Botox injections may become even more popular now that the U.S. Food and Drug Administration has approved its use for frown lines.

On April 15 the FDA announced the approval of Botulinum Toxin Type A, or Botox Cosmetic, to temporarily improve the appearance of moderate to severe frown lines between the eyebrows, a medical condition that is not serious.

Although the drug has long been used for frown lines, the product's manufacturer, Allergan Inc. in Irvine, Calif., is now allowed to market the toxin for cosmetic purposes. The company, which trades on the New York Stock Exchange under the symbol AGN, posted $226.7 million in net income last year and $1.75 billion in net sales.

Although the approval is long overdue, Dr. John Grossman of Denver said, the FDA decision may also put the drug in the hands of more people who are not trained in cosmetic procedures.

According to the American Society for Aesthetic Plastic Surgery, Botox was the most popular cosmetic procedure in 2000, with over a million performed.

"It's a double-edged sword. FDA approval is long overdue because its use is so well documented for these things," he said. "The negative aspect is that this will add people who are your normal primary care physicians ... [who] will perhaps now start injecting Botox. They may look upon it as an income source."

Grossman says his office has been offering Botox injections for about 10 years. His staff performs about 30 to 40 injections a day.

The FDA approved Botox in December 1989 to treat two eye-muscle disorders and expanded that approval in December 2000 to treat cervical dystonia, a neurological movement disorder that causes severe neck and shoulder contractions.

Small doses of the toxin are injected into the affected muscles and block the release of the chemical acetylcholine, which would otherwise signal the muscle to contract. The toxin paralyzes or weakens the injected muscles.

According to the FDA, it is recommended that Botox Cosmetic be injected no more than once every three months, and the lowest effective dose should be used. The most common side effects are headache, respiratory infection, flu syndrome, droopy eyelids and nausea.