FDA Approves Botox for Chronic Migraine
The Food and Drug Administration on Oct. 15 approved onabotulinumtoxinA for the prevention of chronic migraine in adults.
OnabotulinumtoxinA (Botox and Botox Cosmetic) is approved to be administered to patients with chronic migraine (defined as having migraine pain for more than 14 days per month) approximately every 12 weeks in multiple injections around the neck and head to dull future headache symptoms, the FDA announced.
The most common adverse events reported by this population were neck pain and headache.
Botox has not been shown to be effective for treating migraine headache occurring 14 or fewer days per month or for other kinds of headache.
“Chronic migraine is one of the most disabling forms of headache,” Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research in Silver Spring, Md., said in a statement. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” he added.
Labels for Botox and Botox Cosmetic contain a boxed warning stating that botulinum toxin may spread from the injection site and cause potentially life-threatening symptoms – including difficulty swallowing and breathing – that resemble botulism. There have been no confirmed reports of serious toxin spread when Botox has been used at the recommended dose to treat chronic migraine, hyperhidrosis, blepharospasm, or strabismus or when Botox Cosmetic has been used at the recommended dose to treat frown lines, according to the FDA.
Botox and Botox Cosmetic are manufactured by Allergan Inc. of Irvine, Calif.
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