Oct. 18, 2010 FDA approved the use of “Botox to treat chronic migraine headaches in adults”. It had been approved for use for migraines in the UK since July 2010.
The FDA says Botox injections have been shown to be effective in the prevention of migraines, which are debilitating headaches that cause intense pulsing or throbbing pain and affect about 12% of Americans.
“Chronic migraine is one of the most disabling forms of headache,” Russell Katz, MD, of the FDA, says in a news release.
“Botox to give relief to chronic migraines is given at intervals of about 12 weeks as multiple injections around the head and neck” to and works to dull future headache symptoms, the FDA says in a statement.
The FDA says it’s important that patients who suffer chronic migraines discuss with their doctors whether this treatment is appropriate for them.
One of the studies the FDA based their decision on is outlined below:
A clinical study, Botulinum Toxin Type A as a Migraine Preventive Treatment, was conducted by Stephen Silberstein, MD, of the Thomas Jefferson University School of Medicine; Ninan Mathew, MD, of the Houston Headache Clinic; Joel Saper, MD, of the Michigan Head Pain & Neurological Institute; and Stephen Jenkins, MD, of Allergan, Inc. for the BOTOX Migraine Clinical Research Group. The objective of the study was “to assess the safety and efficacy of botulinum toxin type A (BOTOX; Allergan, Inc) in the prevention of migraine.”
Compared with subjects who received placebo injections, the subjects in the Botox treatment group experienced:
· significantly fewer migraine attacks per month
· reduced severity of migraine attacks
· fewer days using abortive/rescue medications
· fewer episodes of vomiting
“Pericranial injection of botulinum toxin type A, was found to be a safe treatment that significantly reduced migraine frequency, migraine severity, acute medication usage, and associated vomiting.”