Botox and Other Off-Label Treatments for Migraines

Most migraine management is off-label, doctors say.

ByABC News
September 2, 2010, 6:16 PM

Sept. 10, 2010 -- Migraine sufferers like Barbara Trupin, who endured the severe headaches weekly for almost 20 years, will often do anything to get relief from the severe pain and other disabling symptoms.

Although there are a few medications approved by the U.S. Food and Drug Administration for migraine treatment, there are dozens more off-label ones that doctors and patients resort to when those don't provide relief.

"People will take anything that works," said Dr. Joel Saper, a neurologist at the Michigan Headache and Neurological Institute.

One of the off-label treatments for migraine prevention that works for some sufferers is Botox.

"It can help some patients who have not responded to other treatments," said Dr. Robert Kaniecki, assistant professor of neurology and director of The Headache Center at the University of Pittsburgh. However, he said it's often a last resort for patients because insurance companies may not cover it unless a patient can prove all other medications have been ineffective.

Botox injections may be administered in a variety of places, depending on where the pain is.

"It can be given over the bridge of the nose, over the eyebrows, or the back of the neck or shoulders," said Dr. Alan Rapoport, clinical professor of neurology at the David Geffen School of Medicine at UCLA. "It works for three to four months and there aren't usually too many side effects."

Allergan, the company that makes Botox, recently agreed to pay $600 million to settle criminal and civil complaints over what the U.S. government said was illegal promotion of the product for unintended purposes, including headaches.

Botox was recently approved as a preventive migraine treatment in the United Kingdom, and will be up for review by the FDA in December for the same indication.

Trupin never tried Botox. Instead, she used another off-label but common drug - Tylenol. She took a hefty dose of eight Tylenol, which she said dulled her pain enough to be able to perform household chores and other tasks. She said she never sought medical advice because the eight Tylenol always helped.

Doctors say that eight Tylenol may be excessive and could be potentially toxic if taken weekly for a long time, as Trupin did. But they say using off-label medications and treatments is very common when nothing else works. They also say these medications and treatments are sometimes more effective than anything that's approved.