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

Big step towards cure for HIV and other lifelong viral infections

SURVEY RESULTS: Attitudes About Fatigue

Superfood Trio: Ginger, Turmeric, and Carrots?

Rejuvenate Your Skin Naturally With Sea Buckthorn Oil

A Smile

Can Drinking More Water Help You Lose Weight?

Resveratrol’s Link to Slowing Alzheimer’s

Tropical Turmeric Carrot Juice & Smoothie

Most Everyone Can Use More Vitamin D

Omega-3s May Improve Healing After a Heart Attack

 
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.



Post a Comment

Featured Products From the ProHealth Store
Ultra EPA  - Fish Oil Ultra ATP+, Double Strength Vitamin D3 Extreme™

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


 
Natural Pain Relief Supplements

Featured Products

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
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

Fighting Fatigue with Ground-breaking French Oak Wood Extract Fighting Fatigue with Ground-breaking French Oak Wood Extract
Itching to Find Dry Skin Relief? Itching to Find Dry Skin Relief?
How Glutathione Can Save Your Life How Glutathione Can Save Your Life
Red Yeast Rice - Natural Option for Supporting Healthy Cholesterol Red Yeast Rice - Natural Option for Supporting Healthy Cholesterol
Reversing Neurodegeneration with a New Magnesium Compound Reversing Neurodegeneration with a New Magnesium Compound

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