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

Patient Insights into the Design of Technology to Support a Strengths-Based Approach to Health Care.

Greater intake of dietary omega-3 fatty acids associated with lower risk of diabetic retinopathy

SURVEY: Weight Management & Chronic Illness

Japanese green tea consumers have reduced risk of dementia

Do Nothing, Accomplish Everything! The Connection Between Breathing and Healing

Best Herbs to Help With Insomnia

Nature Heals

Meet the ProHealth Editors

Choline: Why You Should Eat Your Egg Yolks and Take Krill

Calcium, vitamin D supplementation associated improved stroke recovery

 
Print Page
Email Article

Will Duloxetine Be First FDA-Approved Fibromyalgia Therapy?

  [ 597 votes ]   [ 2 Comments ]
By Editor • www.ProHealth.com • March 3, 2007


On February 26, 2007, the FDA approved Eli Lilly’s pain/sleep/mood drug duloxetine hydrochloride (CymbaltaR) for treatment of generalized anxiety disorder - a condition that seems to affect Fibromyalgia patients more frequently than the general population. At the same time, Lilly announced that later in 2007, subsequent to phase III trials, it expects to ask the FDA to approve duloxetine for treatment of FM pain. (Even as phase II and III trials for treatment of CFS patients proceed in collaboration with the University of Cincinnati.)

Nevertheless, duloxetine is a very potent drug - like others in its class - with potentially serious adverse effects. Just what is it, and what benefits and risks might it represent for FM patients [and CFS patients] if approved?

A Widely Studied Drug
Duloxetine has now been studied in more than 25,000 patients worldwide, according to Lilly. It was previously FDA-approved for treating major depression and managing diabetic neuropathic pain.

How Does The Drug Work?
Duloxetine is a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRIs). According to Lilly, “Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord).

“While the mechanism of action of duloxetine is not fully known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.”

Potential Benefits and Risks for Fibromyalgia Patients?
U.S. and Canadian trials of duloxetine in depressed and nondepressed Fibromyalgia patients have indicated that “while some effects of duloxetine on painful symptoms can be accounted for by its antidepressant action, the data strongly suggest that duloxetine also exerts a substantial direct analgesic effect over and above its antidepressant effects.” See the review, “Efficacy of duloxetine in painful symptoms: An analgesic or antidepressant effect?” and “Duloxetine Reduces Fibromyalgia Pain.”

Importantly, however, a recent review of trial reports in the French journal Prescrire advised physicians that duloxetine's efficacy for treating these two conditions has "not yet been demonstrated to be even equivalent to other available drugs, and has too many adverse effects, given this degree of uncertainty."

According to Wikipedia's discussion of the drug and its adverse effects, "Since duloxetine is a newer drug (FDA-approval 2004), not many peer-reviewed articles have been published on its adverse effects, and effect of long term use is still unknown. More than 40 different types of adverse effects have been reported, including completed suicide attempts and severe hepatic [liver] disorders." Also cited is a report in The Independent, a British newspaper, claiming that investigative reporters had "uncovered 41 deaths and 13 suicides for patients taking duloxetine as of June 19, 2005."

What Is Generalized Anxiety Disorder (GAD)?
GAD is a condition that affects more than 6.5 million Americans in any given year - and may occur more frequently in FM patients than the general population. (See "Does the high frequency of manic symptoms in Fibromyalgia influence the choice of treatment?" )

Symptoms persist for at least six months and can include exaggerated worry or chronic anxiety, irritability, poor concentration, sleep disturbance, and fatigue. The disorder may be brought on, or worsened by, stressful life events, and tends to be chronic with periods of exacerbation and remission.

In clinical trials, Lilly reports that on average, patients treated with CymbaltaR for generalized anxiety disorder (also subject to the potential adverse effects discussed above) experienced a 46 percent improvement in anxiety symptoms, compared to 32 percent for those who took placebo, as measured by the Hamilton Anxiety Scale. In addition, patients in these studies experienced a 46 percent improvement in function, compared to 26 percent for those who took placebo as measured by the Sheehan Disability Scale.

_____
Note: This information has not been evaluated by the FDA. It is not intended to prevent, diagnose, treat, or cure any condition, illness, or disease. It is essential that you never make any change in your healthcare plan or regimen without first researching and discussing it in collaboration with your professional healthcare team.




Post a Comment

Featured Products From the ProHealth Store
Optimized Curcumin Longvida® Energy NADH™ 12.5mg Ultra ATP+, Double Strength

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


Article Comments Post a Comment

BUT it works on women only
Posted by: geekygranny
Mar 13, 2007
My husband has tried it and it doesn't work on him. And research has shown that it has no effect on men just women. We need more research for meds that will work on men as well. Though they are in the minority they still suffer. It works on me great but on him no results. The Editor should have pointed out the genders of the patients because that is very significant when you look at success and failure of these studies. Geekygranny
Reply Reply

Cymbalta
Posted by: nancyct
Mar 15, 2007
I've been changed to Cymbalta for a few months now. Luckily I have not experienced any negative side effects. I have noticed that it works as well with my heightened anxiety and PTSD as a high dosage of Effexor XR.All of the other anxiety medications that I have tried caused me considerable weight gain. So far, I have not had any weight gain and with mild exercise and watching what I eat I have been able to start losing a few pounds. I have also noticed that Cymbalta has allowed me to start getting more sleep at night. Prior, I could only get between 2 and 4 hours of sleep with constant pain and a mind that wouldn't turn off... even with sleep aids. Good luck with trying Cymbalta. I am a disabled woman and found a little better quality of life with it.
Reply Reply
 
Natural Pain Relief Supplements

Featured Products

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
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Repair Damaged Mitochondria and Reduce Fatigue Up to 45% Repair Damaged Mitochondria and Reduce Fatigue Up to 45%
Complete and Natural Menopause Relief Complete and Natural Menopause Relief
Reversing Neurodegeneration with a New Magnesium Compound Reversing Neurodegeneration with a New Magnesium Compound
Strontium - The Missing Mineral for Strong Bones Strontium - The Missing Mineral for Strong Bones
How I Found My Long-Lost Energy How I Found My Long-Lost Energy

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. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map