The makers of the miracle toxin that erases frown lines by paralyzing facial muscles won the
on Friday to market
for the prevention of chronic
. The FDA's decision expands the potential market for Botox, which burst upon the American cosmetic scene in the late 1980s, to 12% of the U.S. population -- the proportion of Americans thought to suffer from the throbbing, pulsating pain of
The agency's approval Friday allows
, which produces a purified version of the botulinum toxin, to advertise to consumers and promote to doctors the use of Botox for chronic migraine, defined as migraine headaches that occur more than 14 days per month. Injected at multiple sites around the head and neck about every 12 weeks, Botox was found to dull the pain of future migraines.
The FDA underscored Friday that Botox does not appear to be useful in treating or preventing less frequent migraines, or
that are not caused by the activation of nerve fibers within the brain's blood vessels--the definition of migraine headache.
Side effects reported included
and--wait for it--headache. The FDA has ordered a "black box" warning on Botox packaging advising consumers that its active agent can migrate to other parts of the body, causing life-threatening reactions. But the agency said Friday that there has not been a confirmed case of such migration in cases in which Botox was used at recommended doses.
Friday's decision by FDA marks a major step in the march of Botox toward ubiquity. Since its introduction to the market as a cosmetic product, Botox has become a popular, but niche, medical product favored by aging baby boomers and movie actors (its powers of facial paralysis have been
for causing a dramatic decline in the quality of acting on the big-screen). Botox has also won FDA approval as a treatment for excessive sweating and for involuntary spasms of the cervix and eyelids. Its use as a migraine treatment is likely to bring it into primary-care offices everywhere.
Beverly Hills plastic surgeon
, who has used Botox in treatment of migraine headaches since the early 1990s, applauded the FDA's decision.
patients are often ineffective...and they offer no hope of preventing future migraines," said Binder. "When administered properly, this Botox treatment offers long-acting, well-tolerated preventative therapy and fulfills an unmet need in the treatment of these patients."