NOTE: On March 30, 2007 the FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate. Click Here to read the entire FDA Press Release.
FDA Approves First Treatment for Women With Constipation-Predominant Irritable Bowel Syndrome
The Food and Drug Administration (FDA) today (July 24, 2002) 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.
For more, please visit the Irritable Bowel Syndrome Center.
Source: Federal Drug Administration press release #T02-33, July 24, 2002