Archived – Important Safety Update: Diarrhea and Ischemic Colitis in Patients Using ZELNORM (Tegaserod Hydrogen Maleate)

Starting date:

April 28, 2004

Posting date:

May 6, 2004

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-17000895

This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on ZELNORM (tegaserod hydrogen maleate)

April 28, 2004

Subject: Important Safety Update: Diarrhea and Ischemic Colitis in Patients Using ZELNORM* (tegaserod hydrogen maleate)

Dear Health Care Professional,

As per the Novartis commitment to provide accurate and updated information we are writing to inform you of important safety information regarding the product Zelnorm*. 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. This is an update regarding serious consequences of diarrhea and new information about rare reports of ischemic colitis in post marketing use of Zelnorm*. The maximum duration of treatment should be no longer than 12 weeks and treatment should be discontinued if there has been no response after 4 weeks.

Diarrhea

Serious consequences of diarrhea, including hypovolemia, hypotension, and syncope have been reported in clinical studies and during marketed use of Zelnorm*. In some rare cases, these complications have required hospitalization for rehydration. Zelnorm* should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm* should not be initiated in patients who are currently experiencing or frequently experience diarrhea.

For your further information, in clinical studies, a small number of patients (0.04%) experienced clinically significant diarrhea including hospitalization, hypovolemia, hypotension and need for intravenous fluids.

Ischemic Colitis

Rare cases of ischemic colitis and other forms of intestinal ischemia have been reported in patients receiving Zelnorm* during marketed use of the drug. A causal relationship between Zelnorm* use and these events has not been established. Clinical trials in approximately 11,000 patients on Zelnorm* showed no cases of these events. Zelnorm* should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. Patients developing these symptoms should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Zelnorm* should not be resumed in patients who develop findings consistent with ischemic colitis.

Information to be provided to the Patients

• In cases of severe consequences of diarrhea (including being light-headed, dizzy, or faint), patients should be advised to stop taking Zelnorm* and seek medical attention right away
• Patients should stop Zelnorm* treatment and seek medical attention if they experience new or worsening abdominal pain with or without rectal bleeding and/or blood in the stool.

The clinical data regarding these reported safety events will be reviewed and evaluated by Novartis Pharmaceuticals Canada Inc. and Health Canada and appropriate regulatory action (e.g.: amendments to the Product Monograph) will be taken. Novartis Pharmaceuticals Canada Inc. has also issued a Public Advisory to inform patients of this important safety information.

Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments.

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.

The identification, characterization, and management of marketed health product-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of serious consequences of diarrhea or ischemic colitis or other serious and/or unexpected adverse events in patients receiving Zelnorm* should be reported to:

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

Should you have any questions or require additional information regarding the use of Zelnorm* (tegaserod) , please contact Novartis Pharmaceuticals Canada Inc., Medical Information at 1-800-363-8883 from 8:30 AM to 4:30 PM Monday to Friday Eastern Standard Time.

Sincerely,

original signed by

Pier-Giorgio Fontana, PhD
Vice-President, Drug Regulatory Affairs

Jean-Marie Leclerc, M.D., F.R.C.P. (c)
Vice-President, Medical Affairs

*Zelnorm is a registered trademark