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

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

How One LLND Treats Lyme disease and Co-infections Using Natural Medicine

Surprising Benefits of Cinnamon

New depression diagnosis and treatment

Specific vitamin D levels linked to heart problems

A Sleep Intervention For Children With Autism: A Pilot Study

Higher vitamin D levels may be protective against acute rhinosinusitis

Basic Vitamin A Primer

Saffron reduces oxidative stress in metabolic syndrome patients

Pilot Study: Measuring Relaxation Response to the iLs Dreampad

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 ] • 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 ATP+, Double Strength Vitamin D3 Extreme™ 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

Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Subscribe Now!
Receive up-to-date ME/CFS, Fibromyalgia & Lyme Disease treatment and research news
 Privacy Guaranteed  |  View Archives

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Featured Products

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
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%

Natural Remedies

Repair Damaged Mitochondria and Reduce Fatigue Up to 45% Repair Damaged Mitochondria and Reduce Fatigue Up to 45%
Natural Support for Mood, Sleep and Mental Focus? L-theanine Natural Support for Mood, Sleep and Mental Focus? L-theanine
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12

What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Causes
Fibromyalgia Treatments
Fibromyalgia Diet
Fibromyalgia Medications
M.E. & CFS
What is M.E./CFS?
M.E./CFS Diagnosis
M.E./CFS Symptoms
M.E./CFS Causes
M.E./CFS Treatments
M.E./CFS Diet
M.E./CFS Medications
What is Lyme Disease?
Lyme Disease Diagnosis
Lyme Disease Symptoms
Lyme Disease Causes
Lyme Disease Treatments
Lyme Disease Diet
Lyme Disease Medications
M.E. & CFS
Lyme Disease
General Health
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing