FDA Approves Botox for Chronic Migraine Treatment

Drug approved for administration every 12 weeks in an effort to reduce future headache symptoms
By Beth Gilbert
HealthDay Reporter

MONDAY, Oct. 18 (HealthDay News) -- On Friday, Oct. 15, 2010, the U.S. Food and Drug Administration announced the approval of onabotulinumtoxinA (Botox) injection for the prevention of headaches in adult patients with chronic migraines.

Chronic migraine is a serious condition that involves intense pulsing or throbbing pain in one area of the head and can be accompanied by nausea, vomiting, and sensitivity to light and sound, with patients experiencing a headache more than 14 days per month. OnabotulinumtoxinA is approved for the treatment of chronic migraines but has not been shown to be effective in the treatment of episodic migraines that involve intermittent headache attacks 14 days or less each month.

For the treatment of chronic migraines, onabotulinumtoxinA is given approximately every three months as multiple injections around the head and neck in an effort to reduce future headache symptoms. The most common adverse events associated with onabotulinumtoxinA include neck pain and headache. While the onabotulinumtoxinA label includes a boxed warning indicating the risk of symptoms similar to those of botulism that can be life threatening, no serious adverse events have occurred with the use of onabotulinumtoxinA at the recommended dose to treat chronic migraine and other approved indications.

"Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available," Russell Katz, M.D., of the FDA's Center for Drug Evaluation and Research, said in a statement.

Botox is manufactured by Allergan Inc.

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