Activate Now
 
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

Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Social Anxiety Disorder Linked to High Serotonin Levels, Throwing Treatment with SSRIs into Serious ...

A short-term Borrelia burgdorferi infection model identifies tissue tropisms and bloodstream surviva...

Therapeutic Effects and Mechanisms of Action of Rifaximin in Gastrointestinal Diseases

Promoting Optimal Nutrition with Digestive Enzymes

Immune response to a flu vaccine yields new insights into narcolepsy

Omega-3 supplements and antioxidants may help with preclinical Alzheimer's disease

Children with Lyme Disease

Health Benefits of Ginseng

7-Keto DHEA The Fat-Burning Metabolite of DHEA

Intestinal Pseudoobstruction Caused by Chronic Lyme Neuroborreliosis. A Case Report

 
Print Page
Email Article

EU Equivalent of FDA Declines to Recommend Cymbalta as Therapy for Fibromyalgia

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


Oct 23, 2008: Cymbalta/Xeristar - the second drug to receive FDA approval for treatment of fibromyalgia - has not been recommended for treatment of FM in Europe. The Committee for Medicinal Products for Human Use, which advises the European Medicines Agency on approvals of drugs for community-wide marketing authorization, has issued a negative opinion on this indication.

Cymbalta/Xeristar has been approved since 2004 in the EU for treatment of major depression, pain of diabetic peripheral neuropathy, and generalized anxiety disorder, and under other names has been approved as a therapy for stress urinary incontinence.

The drug is believed to work by raising levels of the neurotransmitters serotonin and noradrenaline in the spinal cord and brain (by blocking their re-uptake), thereby supporting cell-to-cell communication. These neurotransmitters are thought to play a role in fibromyalgia, and trials of Cymbalta/Xeristar have focused on measuring improvement of FM symptoms with a focus on pain, in patients with and without depression.

The CHMP expressed concern that the improvement demonstrated in FM trials was modest, might be owing to the drug's effect on mood, and as such did not outweigh the drug's risks. It suggested that a long-term placebo controlled trial would be needed.

The drug's makers have the opportunity to request a re-examination of the opinion, and have not indicated plans for a long-term controlled trial in the EU.



Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Nutritional Supplement Orders

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
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

Fighting Fatigue with Ground-breaking French Oak Wood Extract Fighting Fatigue with Ground-breaking French Oak Wood Extract
How I Found My Long-Lost Energy How I Found My Long-Lost Energy
Secret Nutrient for Radiant Skin Secret Nutrient for Radiant Skin
Anti-Inflammatory Properties of Tart Cherry Anti-Inflammatory Properties of Tart Cherry
Carry a Massage Therapist in Your Pocket Carry a Massage Therapist in Your Pocket

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS Diagnosis
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE  |  PRIVACY
CONTACT US
LIBRARY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing