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
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

High dose vitamin D3 supplementation lowers inflammatory T cells in multiple sclerosis patients

Chocolate's Potential Health Benefits – and its Effect on Chronic Fatigue Syndrome Patients

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Essential Oils - How and Where to Use Them

The Link Between Vitamin C And Optimal Immunity

SURVEY: What Is Your Diagnosis?

Liposomes Deliver Optimal Nutrient Absorption

Why Does Your Nose Run When It's Cold Outside?

What's So Great About Grape Seed?

How Your Mitochondria Influence Your Health

 
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
Ultra EPA  - Fish Oil Ultra ATP+, Double Strength Optimized Curcumin Longvida®

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


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

How Glutathione Can Save Your Life

Featured Products

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
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

Prepare Yourself for Cold & Flu Season Prepare Yourself for Cold & Flu Season
Green Coffee Extract: Unique Obesity Intervention Green Coffee Extract: Unique Obesity Intervention
The Revolutionary 'Good Fat' That Promotes Heart, Brain, Bone and Joint Health The Revolutionary 'Good Fat' That Promotes Heart, Brain, Bone and Joint Health
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Priming Your Immune System for Cold & Flu Season Priming Your Immune System for Cold & Flu Season

FIBROMYALGIA
What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Causes
Fibromyalgia Treatments
Fibromyalgia Diet
Fibromyalgia Medications
M.E. & CFS
What is M.E./CFS?
M.E./CFS Diagnosis
M.E./CFS Symptoms
M.E./CFS Causes
M.E./CFS Treatments
M.E./CFS Diet
M.E./CFS Medications
LYME DISEASE
What is Lyme Disease?
Lyme Disease Diagnosis
Lyme Disease Symptoms
Lyme Disease Causes
Lyme Disease Treatments
Lyme Disease Diet
Lyme Disease Medications
FORUMS
Fibromyalgia
M.E. & CFS
Lyme Disease
General Health
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