Botox Approved for Headache Prophylaxis in Chronic Migraine

The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox; Allergan Inc) for headache prophylaxis in patients with adult chronic migraine who suffer headaches on 15 or more days per month, each lasting more than 4 hours.

“Chronic migraine is one of the most disabling forms of headache,” said Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement. “Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

To treat chronic migraine, onabotulinumtoxinA is given approximately every 12 weeks as multiple injections around the head and neck “to try to dull future headache symptoms,” the FDA statement notes. It has not been shown to work for the treatment of episodic migraine headaches that occur 14 days or fewer per month, or for other forms of headache, it adds.

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

Marketed as Botox and Botox Cosmetic, onabotulinumtoxinA has a boxed warning that 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, the FDA statement adds. 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,” the FDA notes.

Susan Jeffrey, For Complete article, Click Here.

J. Kyle Mathews, MD

Plano OB Gyn Associates

Plano Urogynecology Associates

Tags: adult, Botox, Botox Cosmetic, botulinum toxin, Dr. Mathews, FDA, headache symptoms, kyle mathews, migraine headaches, Patients, Russell Katz, Susan Jeffrey, symptoms | Category: News & Education |