ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

SURVEY: Cognitive Impairment II

Top 3 Nutrients to Detox the Liver and Soothe Digestion

Natural Bladder Control, Go Less and Live More

Vital Molecule Increases Cellular Energy and Improves Cognitive Function

Top Vitamin and Mineral Deficiencies — Are You at Risk?

How Pomegranate May Protect Against Cancer

Omega Fix for Obesity: How the Right Fats Fight Fat

Trimming the spare tire: Canola oil may cut belly fat

The Onion: Cancer Fighter and Food Preserver

Fighting Heartburn and Gerd Naturally – And Safely!

 
Print Page
Email Article

EU Equivalent of FDA Fails to Recommend Approval of Cymbalta as Fibromyalgia Drug

  [ 5 votes ]   [ Discuss This Article ]
www.ProHealth.com • October 24, 2008


Oct 23, 2008 - Cymbalta/Xeristar (generic name duloxetine, ) - the second drug in the U.S. to receive FDA approval for the treatment of Fibromyalgia in June 2008 – received a “negative opinion” on its authorization as a treatment for FM with & without depression from the Committee for Medicinal Products for Human Use. Within the European Medicines Agency, this committee is responsible for assessing products for which community-wide marketing authorization is sought.

Cymbalta/Xeristar has been authorized in Europe since 2004 as a treatment for major depression, diabetic neuropathy pain, and generalized anxiety disorder. Under other names it is also authorized for use in stress urinary incontinence. The use for FM would be an "extension of indication." It is delivered in a “gastroresistent" capsule that protects it from being broken down by stomach acid so that it can reach the intestine.

Cymbalta is believed to raise levels of the neurotransmitters serotonin and noradenalin (by blocking their “re-uptake”) in the spaces between nerve cells of the spinal cord and brain – thereby improving cell-to-cell communication. Trials of the drug as a treatment for fibromyalgia focused on measuring its ability to improve symptoms – especially pain levels – and overall health status.

In reviewing the results of 5 clinical studies of Cymbalta, the Committee for Medicinal Products for Human Use:
• Expressed concern that the drug’s effect on symptoms of FM was modest, and could be owing to an improvement in mood.
• Stated that on this basis the demonstrated benefits for FM patients did not outweigh its risks.
• Suggested that a long-term placebo controlled study would be needed to better determine the drug’s effectiveness.

The drug makers may respond with a request that the opinion be re-visited, but reportedly have indicated they have no long-term European trials planned at this time.

 





Post a Comment

Featured Products From the ProHealth Store
Mitochondria Ignite™ with NT Factor® Ultra ATP+, Double Strength Optimized Curcumin Longvida®


Article Comments



Be the first to comment on this article!

Post a Comment


 
Natural Pain Relief Supplements

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium

Natural Remedies

Sleep Like a Baby in Nature's Cradle Sleep Like a Baby in Nature's Cradle
Can Glycine + Amino Acids Be the Secret to Deep, Rejuvenating Sleep? Can Glycine + Amino Acids Be the Secret to Deep, Rejuvenating Sleep?
Block Acid Reflux to Prevent Esophageal Problems! Block Acid Reflux to Prevent Esophageal Problems!
Quercetin: Natural Support for Allergy & Inflammation Relief and More Quercetin: Natural Support for Allergy & Inflammation Relief and More
Top 3 Nutrients to Detox the Liver and Soothe Digestion Top 3 Nutrients to Detox the Liver and Soothe Digestion

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map