IBS Medication Withdrawn: Canadian Society of Intestinal Research Urges Patients to Double-check their medicine cabinets

Thursday, April 5, 2007

Toronto, ON - On the eve of IBS (Irritable Bowel Syndrome) Awareness month, the prescription medication Zelnorm™ (tegaserod hydrogen maleate) was withdrawn from the market to permit further evaluation of important safety information. The Canadian Society of Intestinal Research (CSIR) fears Canadians may still be taking the medication.

Zelnorm is one of only a few medications available in Canada to treat Irritable Bowel Syndrome with constipation in women, and chronic constipation in adults younger than 65 years of age.

Health Canada and the FDA both directed Novartis Pharmaceuticals to suspend sales and marketing of Zelnorm after a recent analysis of clinical trial data revealed a very slight increase in heart attack, stroke, and chest pain. Most of these events occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors, such as a history of high blood pressure, high cholesterol, and previous cardiovascular disease. There were no reported adverse events in Canada.

"Our concern is for IBS patients who may still be taking this medication, unaware that it has been withdrawn from the market," says Dr. James Gray, a consultant in Gastroenterology and Internal Medicine at Vancouver General Hospital and an Assistant Professor of Medicine at the University of British Columbia. "Patients should return to their physicians to find an alternate management plan for their IBS."

IBS affects up to 20 per cent of the population, representing at least six million Canadians. IBS patients suffer daily with what the CSIR describes as the ABCDs of IBS - abdominal pain, bloating or gas, constipation, and/or diarrhea.

"While withdrawal of this medication from the market is disappointing to those patients who were helped by the product, safety comes first," says Gail Attara, Executive Director of the CSIR. "Patients need to know that it is important to heed Health Canada's warnings pending further study." Patients should discontinue Zelnorm treatment immediately, see their physicians to request an alternative prescription IBS product, and can return any unused Zelnorm tablets to their pharmacist.

About CSIR

The Canadian Society of Intestinal Research (CSIR) is a registered national charity dedicated to increasing public awareness, providing patient educational materials, leading in patient advocacy, and funding medical research regarding a broad range of gastrointestinal diseases and disorders. The Society helps Canadians suffering from IBS find ways to manage the condition and continue improving their quality of life.

From more information please contact: Gail Attara - 604-875-4875