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

Benefits of Coconut Oil Are Undeniable

Acupuncture used in clinical settings reduced symptoms of menopause

CoQ10 supplementation associated with lower pro-inflammatory factors in randomized trial

How Awesome Is Ashwagandha?

SURVEY RESULTS: Should Opioids Be Restricted for Chronic Illness?

Clinical trial demonstrates success of low FODMAP diet

Turmeric: The Spice of Life

Research Demonstrates Superiority of Krill Oil Compared to Fish Oil

What’s so Remarkable About Rosemary?

Vitamin nicotinamide riboside protects mice from diabetes complications

 
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.




Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg Vitamin D3 Extreme™ 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


 
Dr Axe Bone Broth Proteins

Featured Products

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
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
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%

Natural Remedies

Green Coffee Extract: Unique Obesity Intervention Green Coffee Extract: Unique Obesity Intervention
SAD? Coping with Seasonal Affective Disorder
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
D-ficient? Health Risks You Need to Know About D-ficient? Health Risks You Need to Know About
Thyroid Health and Fibromyalgia Thyroid Health and Fibromyalgia

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 AND SAVE 15% NOW*
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

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

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