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

|
|
|
|

Trending News

Gut Bacteria, Artificial Sweeteners and Glucose Intolerance

Reverse Mitochondrial Damage

Culprits of Autism Identified: Toxins, Gut Bacteria, Nutritional Deficiencies, and Vaccines Made wit...

Turmeric compound boosts regeneration of brain stem cells

Use of Broad-Spectrum Antibiotics Before Age 2 Associated with Obesity Risk

CoQ10: The Longevity Factor

Is Homocysteine Making You Sick?

VIDEO: Beautiful Clouds - Relaxation and Meditation

Magnesium: Widespread Deficiency with Deadly Consequences

Elevated plasma biomarkers of chronic inflammation in Gulf War illness

 
Print Page
Email Article

FDA Approves First Treatment for Women with Constipation-Predominant Irritable Bowel Syndrome [Chronic Fatigue Syndrome News]

  [ 110 votes ]   [ Discuss This Article ]
www.ProHealth.com • August 2, 2002


The Food and Drug Administration (FDA) today announced the approval of Zelnorm tablets (tegaserod maleate). This drug is the first to receive FDA-approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. The safety and effectiveness of Zelnorm in men have not been established.

Zelnorm increases the movement of stools (fecal matter) through the bowels. Zelnorm does not cure IBS, nor does it treat diarrhea-predominant IBS. Zelnorm reduces pain and discomfort in the abdominal area, and reduces bloating and constipation.

FDA based its decision to approve Zelnorm on the results of three randomized, double-blind, placebo-controlled clinical studies each lasting 12 weeks.

During the studies, patients were asked each week to rate their overall well-being, symptoms of abdominal discomfort and pain, and altered bowel habits.

At the end of the third month of the studies, the proportion of patients responding favorably to Zelnorm was greater than the proportion of patients responding to placebo. The differences in response rates for Zelnorm vs. placebo were greater at month 1 than month 3 suggesting efficacy may decrease over time. The efficacy of Zelnorm beyond 12 weeks has not been studied.

The adverse event reported most often in association with Zelnorm compared to placebo was diarrhea (9% of patients receiving Zelnorm compared to 4% of patients receiving placebo). The majority of the patients treated with Zelnorm who reported diarrhea had a single episode. In most cases, diarrhea occurred within the first week of treatment. Typically, diarrhea resolved without patients having to discontinue Zelnorm therapy. The discontinuation rate from the studies due to diarrhea was 1.6%.

In addition, an increase in abdominal surgeries was observed in patients on Zelnorm (0.3%) compared to placebo (0.2%) in the clinical studies. The increase was primarily due to gall bladder removals reported in patients treated with Zelnorm (0.17%) compared to placebo (0.06%). A causal relationship between abdominal surgeries and Zelnorm has not been established.

Today's action follows the recommendation for approval made by FDA's Gastrointestinal Drugs Advisory Committee on June 26, 2000. FDA had required additional efficacy and safety information following that meeting because there were conflicting results in the efficacy studies and outstanding safety questions.

Novartis Pharmaceuticals Corporation of East Hanover, N.J., is the sponsor of the approved New Drug Application (NDA) for Zelnorm.




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 Vitamins and Supplements

Featured Products

Vitamin D3 Extreme™ by ProHealth Vitamin D3 Extreme™ by ProHealth
50,000 IU Vitamin D3 - Prescription Strength
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Optimized Curcumin Longvida® by ProHealth Optimized Curcumin Longvida® by ProHealth
Supports Cognition, Memory & Overall Health
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
FibroSleep™ by ProHealth FibroSleep™ by ProHealth
The All-in-One Natural Sleep Aid

Natural Remedies

The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol
Sunshine Vitamin Has D-lightful Health Benefits Sunshine Vitamin Has D-lightful Health Benefits
Protect Against Sun-Induced Skin Aging From The Inside Out Protect Against Sun-Induced Skin Aging From The Inside Out
VIDEO: Healthy Eating and Fibromyalgia VIDEO: Healthy Eating and Fibromyalgia
The Big Blue Fish that Helps Chase the Blues Away The Big Blue Fish that Helps Chase the Blues Away

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing