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Voluntary suspension of sales of Zelnorm due to cardiovascular ischemic events - For Health Professionals
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TThis is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
March 30, 2007
Subject: URGENT: Marketing and Sales Suspension Notice for Zelnorm* Tablets, 6 mg
Dear Health Care Professional:
At Health Canada's request, Novartis Pharmaceuticals Canada Inc. is suspending marketing and sales of Zelnorm* (tegaserod hydrogen maleate) tablets in Canada to permit further evaluation of important safety information.
Zelnorm is a serotonin 5-HT4 receptor partial agonist indicated for the symptomatic treatment of irritable bowel syndrome with constipation (IBS-C) in female patients whose main symptoms are constipation and abdominal pain and/or discomfort and for the treatment of chronic idiopathic constipation (CIC) in patients under 65 years of age.
A recent retrospective analysis of pooled clinical trial data showed that the incidence of cardiovascular ischemic events1 in patients taking Zelnorm was higher than in those taking placebo:
- In clinical studies involving over 18,600 patients, there was a statistically significant increase in the incidence of cardiovascular ischemic events1 [13 out of 11,614 (0.11%) Zelnorm; 1 out of 7,031 (0.01%) placebo (p = 0.024)].
- While most of these patients had at least one CV risk factor, for some, cardiovascular disease or risk had not been diagnosed at the initiation of treatment.
Consistent with the decision to suspend marketing and sales of Zelnorm, Novartis is asking Canadian pharmacists and distributors to return the product to the company. Patients taking Zelnorm should discontinue treatment and contact their physician for advice about alternative therapies. Novartis has also suspended the marketing and sales activities of Zelnorm in the United States at the request of the Food and Drug Administration.
Advice to Health Care Professionals:
Prescribers are advised:
- Not to initiate treatment of new patients;
- To review treatment options for patients currently taking Zelnorm;
- To return Zelnorm samples to Med-Turn International. A separate communication on the return process is currently being distributed.
Pharmacists are advised:
- Not to dispense further prescriptions for Zelnorm;
- To advise patients to discontinue Zelnorm and contact their physicians if they have any concerns;
- To return Zelnorm tablets to Med-Turn International. A separate communication on the return process is currently being distributed.
Novartis Pharmaceuticals Canada Inc. reiterates its commitment to the delivery of quality pharmaceutical products and is committed to ensuring the timely dissemination of new information that is important to physicians and patients. A brief statement will be placed on the 
http://www.novartis.ca website.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious cardiovascular ischemic events or other serious or unexpected adverse reactions in patients receiving Zelnorm should be reported to Novartis or Health Canada at the following addresses:
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, (QC) H9S 1A9
e-mail address: drug.safety@novartis.com
Zelnorm Hotline:1-877-519-5399
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738
Should you have any questions or require additional information regarding the use of Zelnorm, please contact the Zelnorm Hotline at 1-877-519-5399.
Sincerely,
original signed by
Vice-President
Regulatory Affairs
Chief Scientific Officer and Senior Vice-President Clinical and Regulatory Affairs
1 Cardiovascular ischemic events occurring in Zelnorm-treated patients included myocardial infarction, stroke, and unstable angina pectoris.
