Navigation Links
FDA Approves Botox to Treat Chronic Migraine
Date:10/15/2010

SILVER SPRING, Md., Oct. 15 /PRNewswire-USNewswire/ -- 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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)  

"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."

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.

To treat chronic migraines, Botox is 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.

Botox is manufactured by Allergan Inc. of Irvine, Calif.

For more information:

National Institute of Neurological Disorders and Stroke: Hope Through Research

http://www.ninds.nih.gov/disorders/headache/detail_headache.htm#156653138

Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... 2017 Mixed tocopherols market projected to grow at ... is projected to reach USD 5.27 billion by 2022, at ... by factors such as health and wellness trends, for instance, ... regulations for sourcing, processing, packaging, and labeling of food & ... such as the Asia-Pacific region also ...
(Date:2/22/2017)... a condition where an organ of ... to weak abdominal wall. Hernia is classified into ... femoral hernia, umbilical hernia, and other (hiatal hernia ... are performed using a mesh, made-up of biological ... Among the available options, open tension-free repair procedures ...
(Date:2/22/2017)... , Feb. 22, 2017 Summary ... partnering deals and agreements entered into by the worlds ... http://www.reportlinker.com/p03605680-summary/view-report.html Description The Global Spinal Cord Partnering ... access to partnering deals and agreements entered into by ... in partnering deals - Top deals by value ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... ... and community for those in the fight against cancer, has produced a seminal ... success. HRA will release top-line findings in a webinar, Defining Compassionate Care ...
(Date:2/23/2017)... ... (PRWEB) February ... for the nation to come together to combine its favorite ... with its favorite fruit – apples! To celebrate National Nutrition ... join the “Apple Madness” bracket tournament – a five-week, five-round ...
(Date:2/23/2017)... , ... February 23, 2017 , ... Top cosmetic and ... Patriot program today with a new Indiegogo campaign . Individuals are now ... veterans in the Los Angeles area, either as a participating patient or through an ...
(Date:2/23/2017)... , ... February 23, 2017 , ... HealthPostures, the desk ... an expert sit stand solutions representative to the Minneapolis Home and Garden Show which ... the event that is garnering national attention is the Minneapolis Convention Center. , ...
(Date:2/23/2017)... ... February 23, 2017 , ... Carlos Gutierrez ... has also continued to spiritually evolve, which is the purpose of everyone in this ... Spiritual Truths ” (published by Balboa Press) attempts to guide readers to expand one’s ...
Breaking Medicine News(10 mins):