FDA Okays Anti-wrinkle Botox for Migraine Headache
Font size:
Those who want to keep their skin looking 10 years younger may have already known about a toxic drug called Botox. The U.S. Food and Drug Administration on October 14 announced it has now approved Botox injections (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine.
Chronic migraine is defined as a condition with a history of migraine in which a person experiences a headache on more than 14 days of the month. The newly approved drug is said to be effective in patients who experience migraine headache for more than 14 days a month.
"Chronic migraine is one of the most disabling forms of headache," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
"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," Katz added.
Migraine headaches can be many types. The classical migraine headaches start with some visual disturbances or aura - patients can see spots, dots, or even zigzag lines. An aura is often followed by a severe headache on one side of the head only.
Another type of migraine headache is the common migraine headache, which may involve the whole head. Some migraines cause visual changes, nausea and vomiting, but no headache.
The U.S. government says it remains unknown what causes migraine, but some foods are known to trigger an episode of migraine headache. The foods of concern include chocolate, cheese, food additives such as mono-sodium glutamate or MSG. Smoking and drinking alcohol may also trigger migraines.
The FDA said Botox, manufactured by Allergan Inc. of Irvine, Calif., can be used every 12 weeks as multiple injections around the head and neck in an effort to dull future headache systems.
The agency did not say how botox works, but it is a fact that botox is a neurotoxin, which renders an effect of botulimum toxin to prevent neurons from responding to the pain signals in an migraine episode.
The FDA did say that Botox did not work in patients who experience migraine headache for less than 14 days per month nor does it work for other types of headache.
The FDA did not mention any trial on which the agency’s approval of Botox for treating migraine headache was based. But a few recent trial studies suggest that botox is effective in treating migraine headache.
Diener H.C. and colleagues from the University of Essen in Germany published in the July 2010 issue of Cephalalgia a trial report saying that onabotulinumtoxinA is effective for prophylaxis of headache in adults with chronic migraine.
In the so-called PREEMPT 2 trial, a phase 3 trial with a 24-week, double-blind, placebo-controlled phase followed by a 32 week, open-label phase, 347 patients received injections of onabotulinumtoxinA and 358 received placebo every 12 weeks for two cycles.
The researchers observed that patients in the study group were free of headache 9 out of 28 days compared with 6.7 days out of 28 days in the control group. The drug helped eliminate about 8 percent of the pain duration.
Adverse effects were few, but 3.5 percent in the study group dropped the treatment compared with 1.4 percent in the control group due to adverse events.
But ironically the most common adverse reactions to the Botox treatment were neck pain and headache, according to the FDA.
The agency also warned that OnabotulinumtoxinA, marketed as Botox and Botox Cosmetic, has a boxed warning that says the toxic effects may spread from the local area of injection to other areas of the body, causing symptoms similar to those of botulism, which leads to life-threatening conditions like swallowing and breathing difficulties. But no such cases have been reported when the drug was used in the recommended dosage.
By David Liu and editing by Rachel Stockton
Add to:
del.icio.us |
Digg
del.icio.us |
Digg
Email to a friend
Print version
Plain text
Home
Set as homepage
Add to favorites
Mobile site
Rss
Plain text
Archive