Archived – Emerging Safety Information: Diarrhea and Ischemic Colitis in Patients Using ZELNORM (Tegaserod Hydrogen Maleate) – Novartis Pharmaceuticals Canada Inc. – For the Public

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

May 3, 2004

Subject: Emerging Safety Information on Zelnorm* (tegaserod hydrogen maleate)

Following discussions with Health Canada, Novartis Pharmaceuticals Canada Inc. would like to update you on new safety information regarding Zelnorm*.

Zelnorm* is used to treat the symptoms of irritable bowel syndrome with constipation (IBS) such as abdominal pain, discomfort, and constipation. This medication should be used only by female IBS patients whose predominant bowel symptom is constipation. The maximum duration of treatment is 12 weeks. If your symptoms do not resolve or improve after 4 weeks taking Zelnorm*, consult with your doctor to discuss whether Zelnorm* should be continued or not.

Zelnorm* can sometimes cause diarrhea. It is usually mild and occurs once or twice in the first few days, and usually resolves itself with the continued use of Zelnorm*. If you experience so much diarrhea that you get light-headed, dizzy, or faint, you should stop taking Zelnorm immediately and should seek immediate medical attention. You should not take Zelnorm* if you are currently experiencing or frequently experience diarrhea. In clinical studies, a small number of patients (0.04%) experienced serious consequences of diarrhea. Also, these effects have been reported rarely in patients since the introduction of Zelnorm* on the market.

In addition, rare cases of ischemic colitis (inflammation of part of the large intestine caused by a reduced blood flow) have been reported in patients receiving Zelnorm* since its introduction on the market. A causal link between Zelnorm use and ischemic colitis has not been established. No cases of ischemic colitis have been reported in approximately 11,000 patients in clinical trials.

Ischemic colitis is very rare, but represents the most common form of ischemic injury to the colon. Ischemic colitis occurs in the general population and tends to be mild and resolve by itself. However, in some cases, ischemic colitis can be serious requiring surgery and in rare cases can lead to death. Recent studies suggest that ischemic colitis is observed more frequently in IBS patients than in the general population.

If you are taking Zelnorm* and experience new or worsening abdominal pain with, or without, blood in your stools, it is important that you seek immediate medical attention.

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.

Novartis Pharmaceuticals Canada Inc. has also issued a letter to health professionals informing them of the above-mentioned safety information. The letter that was sent to health professionals can be found on Health Canada website.

Novartis Pharmaceuticals Canada Inc. is working with Health Canada to evaluate the appropriate regulatory actions (e.g. update to the Canadian Prescribing Information) required based on these data.

If you have questions about your current prescription, please contact your physician or pharmacist.

If you have had a serious or unexpected reaction to Zelnorm* you may notify either Novartis Pharmaceuticals Canada Inc. or Health Canada as follows:

Novartis Pharmaceuticals Canada Inc.
385 Bouchard blvd,
Dorval, (QC) H9S 1A9
Phone:1-800-363-8883 (Medical Information)

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

For other inquiries: please refer to contact information.

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 media inquiries please contact Jason Jacobs at (514) 633-7872.

* Zelnorm is a registered trademark