FDA Approves the Use of Botox for Migraine – at Last

In December 2006 I posted a short piece listing 12 conditions for which Botox had been shown to be effective.  About 10 years ago reports came in that the cosmetic use of Botox in migraine sufferers was accompanied by some relief from their disabling headaches.  Now the FDA has approved Botox for the prophylaxis of chronic migraine (defined as more than 14 migraine days monthly).

Two large placebo-controlled studies involving 1,384 subjects with chronic migraine were submitted to the FDA.  Treatment involved an injection (Botox or placebo) into several areas of the head and neck, every 12 weeks.  In those given Botox there was a significantly greater decrease in the frequency of headache days, compared with placebo, 24 weeks after treatment – an average of 7.8 or 9.2 days for Botox vs. 6.4 and 6.9 days for placebo.  Also, headaches that occurred were shorter in Botox-treated patients.

Side effects reported more often in Botox than in placebo patients included: headache (!), facial paralysis, drooping eyelid, bronchitis, neck pain, stiffness, injection-site pain, and raised blood pressure.  About 1% of patients actually had severe worsening of migraine, requiring hospitalization, within the first week after treatment.

Clearly, the risks of treatment are not inconsiderable, but the rewards may be considerable for migraine sufferers.  If you are one, consider asking your physician if Botox might be worth a trial . . .