In April of this year, the Food and Drug Administration (FDA) gave approval to Botox , botulinium toxin A, for use in the temporary improvement of moderate to severe glabellar lines in adult men and women 65 or younger. These are the lines that appear at the root of the nose during the frown or the "look of consternation." Having personally used Botox hundreds of times since 1997, I would predict that this approval is probably based on the data from clinical use alone. The American Society Of Plastic Surgeons estimates that 855,846 people in the United States for the year 2001 alone had Botox injections. This is an estimate of procedures performed by its members. Looking at the Orange County example many physicians offer Botox injections. Probably less than half of these are plastic surgeons. Botox was FDA approved for use in spastic disorders such as eyelid spasm in 1989.
"Off label use" refers to the use of a drug for purposes for which it is not FDA approved. While this sounds scary, it really isn’t. Many popular drugs were originally FDA approved for purposes other than those for which they are currently used. Years ago, Minoxidil was a medication approved for the use in high blood pressure. Amongst the adverse events associated with the medication was hypertrichosis or hair overgrowth. Well some smart person at Upjohn pharmaceuticals (recently assimilated by Pharmacia) put one and one together. Now Rogaine ® is a huge over-the-counter product used in retarding hair loss.
Botox similarly was approved for use in spastic disorders and was quickly adopted by plastic surgeons for use in "wrinkle reduction." The effect is temporary being seen within a few days of injection and lasting a few months. In clinical trials of Botox, the most frequently reported adverse events were headache (13.3%), respiratory infection (3.5%), blepharoptosis or temporary eyelid droop (3.2%), nausea (3.0%) and flu syndrome (2.0%). As usual for clinical trials, these statistics are much larger than those I see in my own practice. Headache is common although I have yet to see a respiratory infection, nausea or flu syndrome event following Botox injection. I have seen one patient with a droopy eyelid following Botox injection.
FDA Approval, So What Will Change?
FDA approval will probably improve consumer interest in the product, however interestingly the FDA chimed in on safety years ago when they originally approved Botox for use. The consumer demand and widespread use pretty much proved safety. The experience gained in years of off label use demonstrates safety. An interesting wrinkle however (pun intended):
Within a few days of FDA approval Allergan pharmaceuticals announced that the name of the compound would change to Botox ® Cosmetic. My bet is that the price for the material will go up in not too terribly long. Botox isn’t cheap and doesn’t keep for very long either. Sounds better for Allergan investors than for the public at large.
John Di Saia, M.D. is a Plastic and Reconstructive Surgeon practicing in San Clemente. He can be found online via his web site at: www.ocbody.com or via his office at (949) 369-5932.
EDITORIALS | MAIN