Breaking News: Botox approval from FDA

Yesterday the FDA in the United States officially approved Botox for use with chronic migraine patients. This follows a similar approval in Britain for Botox this past summer.

This is a continuation of an up-and-down roller-coaster ride for the controversial treatment. Read more in the New York Times article: Botox Shots Approved for Migraine.

This from the FDA:

To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. It is important that patients discuss with their physician whether Botox is appropriate for them.

The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache.

OnabotulinumtoxinA, marketed as Botox and Botox Cosmetic, has a boxed warning that 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. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when Botox Cosmetic has been used at the recommended dose to improve frown lines.

Side effects have been rare with Botox treatment, but you are wise to find someone experienced giving Botox injections for migraine, referred by a doctor who knows your medical history.

More on an overview of Botox for Migraine, and a little more detail about what a Botox treatment is like.

Check out more about Botox in these posts.

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6 comments… add one
  • Patrice Oct 21, 2010

    I’ve tried Botox, it did not work for me.

  • Karen Anderson Oct 24, 2010

    This is wonderful! I used Botox in July and it cut my migraines in half and more. Stress related migraines were gone. I still have to watch my diet for triggers. I acually have a life now. Thank you both, Botox and FDA, for giving HOPE for those of us who had none.

  • steve Feb 1, 2011

    I received Botox injections from a Neurologist that has been treating me for migraines on 1/21. Within 2 days I had a rash that spread from the back of my legs down to my feet and around each elbow. Using a steroid cream to dull the itching. 11 days later, still dealing with the side effects. I was told this is a very rare. Headaches have been reduced by only a small percentage.

  • Erin Feb 16, 2011

    I’m 6 weeks past my first series of injections and have had some very minor improvements (down from an average of 6 a week to 5, and fewer with severe nausea). My neuro says he’s going to increase the dosage in six weeks when I go for the next series. Years ago, I participated in a study that involved botox injections in the trigger points of the back, neck and shoulders. That helped much more than the current “approved” treatment, but insurance won’t cover it. Cost is around $3000 every 12 weeks. It may be worth it, since my life is hardly worth living at this point. Has anyone else tried the trigger point injections?

    • steve Feb 17, 2011

      My Neurologist gave me Trigger Point Injections with Steroids not Botox. Injections were concentrated around the back of my head and neck plus top of my shoulders. A series of 3 over a 4 week period. Not much help.

  • cbusnitz Sep 26, 2011

    It will be interesting to see if this treatment works. I have not suffered from migraines but I recently saw a few stories on news mags like The Journal with Joan Lunden and CNN that were talking about the number of people who deal with chronic migraines and the effects it has on their lives. It sounds horrible. Hopefully this treatment will have the capability of helping some people.

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