Voluntary suspension of sales of Zelnorm^* due to cardiovascular ischemic events - Novartis Pharmaceuticals Canada Inc.

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
 
This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on
Zelnorm^*(tegaserod hydrogen maleate)

March 30, 2007

Subject: URGENT: Marketing and Sales Suspension Notice for Zelnorm^* Tablets, 6 mg

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 prescription medication used to treat Irritable Bowel Syndrome with Constipation in women, and Chronic Constipation in adults younger than 65 years of age.

Novartis is asking Canadian pharmacies and distributors to return the product to the company. Patients taking Zelnorm should discontinue treatment and contact their doctors to discuss other treatment options. Novartis has also suspended the marketing and sales activities of Zelnorm in the United States at the request of the Food and Drug Administration.

Patients can return any unused Zelnorm tablets to their pharmacists for reimbursement.

As with any drug product, in order to avoid contaminating ground or municipal water systems, the product should not be flushed down the toilet or sink.

Novartis has sent a letter to Canadian health care professionals informing them of this new safety information. You may view this letter on the Health Canada website or at the Novartis website at: http://www.novartis.ca.

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:

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

Pier-Giorgio Fontana, PhD
Vice-President
Regulatory Affairs

Jean-Marie Leclerc, M.D. FRCP(C)
Chief Scientific Officer and Senior Vice-President Clinical and Regulatory Affairs

^*Zelnorm is a registered trademark