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Migraines & Headaches Health Center

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FDA Approves Botox to Treat Chronic Migraines

Injections of Botox Can Relieve Migraine Headache Symptoms for up to 3 Months

Botox Studies continued...

He says with the FDA’s approval of Botox to prevent migraines, there is now a new option “to reduce the days and hours spent in pain as a result of this condition.”

It says the FDA’s approval for use of Botox to fight migraines was based on the results of two studies involving 1,384 adults in North America and Europe.

The studies, published in the March 2010 issue of Cephalalgia, report that patients treated with Botox experienced a major decrease in the frequency of headache days, according to the Allergan statement.

Botox Side Effects

The most common adverse reactions reported by patients being treated for chronic migraine have been neck pain and headache, the FDA says.

The FDA also has placed a “boxed warning” on the anti-migraine drug, onabotulinumtoxinA, marketed as Botox and Botox Cosmetic. The warning says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism.

These symptoms can include swallowing and breathing problems. The FDA says it knows of no confirmed cases of the spread of the toxin effect when Botox has been used at the recommended dose to treat chronic migraines, severe underarm sweating, or conditions such as blepharospasm, an involuntary muscle spasm in the muscles surrounding the eyes.

The drug also can cause muscle weakness, double vision, blurred vision, drooping eyelids, loss of bladder control, and hoarseness, Allergan’s statement says.

The same formulation of Botox was approved by the FDA in 2002 for the treatment of facial frown lines.

The FDA says Botox does not appear to be useful in treating or preventing less frequent migraines that occur 14 days or less per month or other forms of headache.

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