Saturday, October 16, 2010

FDA approves Botox to treat chronic migraine

The U.S. Food and Drug Administration today approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine.
Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.
Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine is three times more common in women than in men.
Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine.
Botox is to be 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.
Currently approved drugs for pain relief in migraine are-
§  Nonsteroidal anti-inflammatory drugs (NSAIDs). These medications, such as ibuprofen (Advil, Motrin, others) or aspirin, may help relieve mild migraines. Drugs marketed specifically for migraine, such as the combination of acetaminophen, aspirin and caffeine (Excedrin Migraine), also may ease moderate migraines but aren't effective alone for severe migraines.
§  Triptans. They are effective in relieving the pain, nausea and sensitivity to light and sound that are associated with migraines. Medications include sumatriptan (Imitrex), rizatriptan (Maxalt), naratriptan (Amerge), zolmitriptan (Zomig), almotriptan (Axert), frovatriptan (Frova) and eletriptan (Relpax).
§  Ergot. Ergotamine (Migergot, Cafergot), Dihydroergotamine (Migranal).
§  Anti-nausea medications. metoclopramide (oral) or prochlorperazine (oral or suppository).
§  Butalbital combinations. Medications that combine the sedative butalbital with aspirin or acetaminophen (Butapap, Phrenlin Forte) are sometimes used to treat migraine attacks. Some combinations also include caffeine or codeine (Esgic-Plus, Fioricet).
§  Opiates. Medications containing narcotics, particularly codeine

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229782.htm

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