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

Scientifically-designed fasting diet lowers risks for major diseases

Is Magnesium the Missing Link in Your Heart Healthy Routine?

More evidence for calorie restriction’s longevity effect

Supplementation with vitamin D associated with improved testosterone, erectile function among middle...

A Little Zinc Goes a Long Way

Vitamin D deficiency increases risk of chronic headache

VIDEO: The Best Brain Foods That Help Increase Your Memory!

Get the Most From Your Green Tea

Iron (And More) For Lasting, Natural Energy

Metabolic syndrome increases the need for vitamin E

 
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™ Optimized Curcumin Longvida® Ultra EPA  - Fish Oil

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


 
NAD+ Ignite with Niagen

Featured Products

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

Natural Remedies

When a Good Night's Sleep Is Just a Daydream... When a Good Night's Sleep Is Just a Daydream...
Cell-Charging Compound Gives Steady Energy to Fibromyalgia & Chronic Fatigue Patients Cell-Charging Compound Gives Steady Energy to Fibromyalgia & Chronic Fatigue Patients
Strengthen Cell Function with Energy-Boosting Niagen Strengthen Cell Function with Energy-Boosting Niagen
Aching Muscles? Top 10 Nutrients to Take Back Your Life Aching Muscles? Top 10 Nutrients to Take Back Your Life
Astaxanthin - A Little-Known but Power-Packed Nutrient Astaxanthin - A Little-Known but Power-Packed Nutrient

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

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map