Botox for Headaches?

Although the use of Botox to smooth out facial wrinkles has been approved by the Food and Drug Administration since 2002, the drug has also been used for years to treat chronic migraine headaches, even though it does not have FDA approval for this use and many skeptics doubt that it’s truly effective. That may soon change.

Allergan, which manufactures Botox, recently claimed that the results of two studies show that periodic injections of the drug can prevent headaches in patients who suffer from chronic migraines.

Allergan said that it would ask the FDA for approval to market Botox as a treatment for chronic migraines, which the company estimated affected between 1.2 million and 3.6 million Americans. Doctors can use an FDA-approved drug to treat any illness, and Allergan’s sales of Botox for migraine treatment are about $50 million a year. An FDA approval of Botox for chronic migraines, however, would allow Allergan to market Botox directly to consumers for that condition, and that could boost Botox sales for migraine treatment as high as $400 million.

Allergan did not release all the data from the studies, but critics who reviewed the research note that results in at least one of the studies were inconclusive. Officials from the America Academy of Neurology, which had issued guidelines earlier this year advising doctors that Botox injections were not an effective treatment for migraines, also noted that any speculation about whether the guidelines would change as a result of the studies would be premature.