Canadian Society of Intestinal Research Urges Patients to Double-check
their medicine cabinets
TORONTO, April 10 /CNW/ - On the eve of IBS (Irritable Bowel Syndrome)
Awareness month, the prescription medication Zelnorm(TM) (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maleate) was withdrawn from the market to permit further evaluation of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unaware that it has been withdrawn from the market," says Dr.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 ABCD's of IBS - abdominal pain, bloating or gas, constipation, and/or
"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.
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.
For further information:
For further information: Gail Attara, Executive Director, Canadian
Society of Intestinal Research, (604) 875-4875 or toll-free 1-866-600-4875,