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

Tea drinkers have lower glaucoma risk

Why Is Chlorella Considered a Superfood?

Soy, cruciferous vegetables could help lower breast cancer treatment side effects

The Long-Term Benefits of Drinking Oolong Tea

Wonderful White Tea: A Drink Fit for an Emperor

Why You Should Try This Sweet-Smelling and Health-Boosting Essential Oil

Arnica: This Powerful Herb Promotes Various Kinds of Healing

Chamomile Tea: Why This Ancient Therapeutic Drink Still Stands Out Today

Get ‘Hooked’ on Cat’s Claw: The Many Benefits of This Amazonian Herb

Try Apple Cider Vinegar and Black Cumin Oil as Your Go-To Salad Dressing

 
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
Vitamin D3 Extreme™ Ultra EPA  - Fish Oil Energy NADH™ 12.5mg


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get Energized with Malic Acid & Magnesium
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
Curcumin - a Golden Gift of Nature with Benefits Still Untold Curcumin - a Golden Gift of Nature with Benefits Still Untold
Breakthrough Form of Magnesium Enhances Memory and Cognitive Function Breakthrough Form of Magnesium Enhances Memory and Cognitive Function
Can Autoimmune Conditions be Reversed? Researchers Make a Surprising Discovery Can Autoimmune Conditions be Reversed? Researchers Make a Surprising Discovery
Natural Relief for Soreness, Pain and Swelling - Putting Out the Fire Natural Relief for Soreness, Pain and Swelling - Putting Out the Fire

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

© 2018 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map