TORONTO, ONTARIO (PRWEB) June 18, 2004
The Zelnorm Action Group and IBS Self Help and Support Group strongly support the use of the drug Zelnorm (tegaserod maleate), the first drug to receive FDA-approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. Zelnorm is to be reviewed for the new indication of chronic constipation at an FDA Gastrointestinal CDER Advisory Committee Meeting on July 14, 2004.
Jeffrey Roberts, President and Founder of the Irritable Bowel Syndrome Self Help Group, and Founder of the Zelnorm Action Group, commented, "We are hearing from a large number of women who are taking Zelnorm for chronic constipation because their doctors believe it will help them. They have commented that they have finally been able to live a more normal life while taking this medication. The Zelnorm Action Group and IBS Self Help Group are beginning a campaign to inform the FDA as to how essential the drug is for our group. We intend to make several patient presentations to the FDA at the CDER Gastrointestinal Advisory Committee Meeting on July 14, 2004 at the FDA offices in Rockville, Maryland."
A member of the IBS Self Help Group wrote "I have been taking Zelnorm for an extended time primarily for chronic constipation and it has changed my life."
Members of the IBS Group have begun to write to the FDA in an effort to tell them the positive effects of the drug and how chronic constipation sufferers are already benefiting from the use of this drug.
Research published in Gastroenterology identifies for the first time a molecular defect in the gastrointestinal (GI) tracts of patients. The findings reinforce the critical role normal serotonin (5-HT) signaling plays in regulating GI function, pinpointing a difference in the way serotonin functions in certain cells lining the GI tract of IBS patients. This defect may underlie the clinical manifestations of IBS -- abdominal pain or discomfort, bloating, constipation and/or diarrhea -- that affect more than 40 million Americans.
In patients with IBS-C, Zelnorm has been shown to effectively restore deficient serotonin signaling by activating 5-HT4 receptors to increase GI motility in the gut. Zelnorm mimics the natural effects of serotonin, strengthening transmission in critical neural pathways, which normalizes impaired motility in the GI tract, inhibits visceral sensitivity (pain perception) and stimulates intestinal secretion of salts and water necessary in normal bowel function.
Background on Zelnorm:
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. The safety and effectiveness of Zelnorm in men have not been established.
Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea
About the Zelnorm Action Group
The Zelnorm Action Group was organized by members of the IBS Self Help Group (http://www.ibsgroup.org) and members in 2001 who had be involved in clinical trials for tegaserod maleate.
The Zelnorm Action Group (ZAG) was seeking access to the medicine Zelnorm (tegaserod maleate). ZAG ultimately seeks permanent access and safe distribution of the medicine to those diagnosed with IBS-Constipation and Chronic Constipation.
The Zelnorm Action Group believes the medicine to be safe, if dispensed properly, and that the benefits of Zelnorm far outweigh the potential risk for adverse side affects.
About the Irritable Bowel Syndrome (IBS) Self Help Group
The IBS Self Help Group is the premier internet self help health site about Irritable Bowel Syndrome, with more than 10,000 members.
The IBS Self Help Group (ibsgroup.org), formed in 1987, is in support of those who suffer from IBS, those who are looking for support for someone who has IBS, and medical professionals who want to learn more about IBS. The IBS website was launched in May 1995. The IBS Self Help Group website provides access to bulletin and chat boards, book list and store, medication listings, diagnosis and treatment, clinical study listings and support groups.
The IBS Self Help Group receives funds from educational grants and advertising of helpful products for sufferers, in order to support its ongoing operations.
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Irritable Bowel Syndrome (IBS) Self Help and Support Group
Jeffrey Roberts, President and Founder
416.932.3311, fax, 416-932-8909
Zelnorm Action Group