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This document is also available in PDF format
Pages: 2, Size: 19 K, Date: 2003-10-21

The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD 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 Bristol-Myers Squibb Canada. Contact the company for a copy of any references, attachments or enclosures.


BMS Canada

October 2, 2003

Dear Health Care Professional,


It has come to the attention of Health Canada that nefazodone has been associated with adverse hepatic events including liver failure requiring transplantation in Canada.

Following discussions with Health Canada, Bristol-Myers Squibb Canada has decided to discontinue sales of nefazodone, effective November 27, 2003.

During this transitional period, healthcare providers are asked to arrange alternative therapies other than nefazodone for their patients.

Bristol-Myers Squibb Canada ("BMSC") would like to advise you of important safety information concerning the antidepressant, nefazodone HCl. Nefazodone, sold by BMSC under the trade name Serzone-5HT2, is indicated for the symptomatic relief of depressive illness. Following discussions with Health Canada concerning reports of hepatotoxicity temporally associated with nefazodone use, BMSC has decided to discontinue sales of the product from the market in Canada effective November 27, 2003.

Since its introduction in 1994, nefazodone has been temporally associated with hepatic adverse events such as jaundice, hepatitis and hepatocellular necrosis in patients receiving therapeutic doses. As of December 2002, there were 51 Canadian reports of hepatotoxicity, ranging from no symptoms to transplantation, suspected to be associated with nefazodone use. One of the two transplant recipients subsequently died. Cases of liver injury have occurred as early as a few weeks after initiation of therapy or after continuous use for up to 3 years. To date, no risk factor to predict patients who will develop irreversible liver failure with nefazodone has been identified. Also no clinical strategy, such as routine liver function tests, could be identified to reduce the risk of liver failure.

Please be advised that on November 27, 2003, Bristol-Myers Squibb Canada will formally discontinue sales of all Serzone-5HT2 (nefazodone) and ask pharmacies to return any remaining products as of November 27, 2003. The Drug Identification Numbers (DINs) for Serzone-5HT2 will immediately thereafter be cancelled by Health Canada.

During this transition period, you are advised to arrange alternative therapies other than nefazodone for your patients. When considering alternative antidepressants for your patients currently taking nefazodone, please note that Serzone-5HT2 should not be used in combination with monoamine oxidase inhibitors. Monoamine oxidase inhibitors should not be introduced until at least seven days after the cessation of Serzone-5HT2 therapy. Please consult the product monographs for both nefazodone and the antidepressant you are considering as replacement therapy before switching your patient.

The identification, characterization, and management of drug-related adverse events are dependent on the active participation of healthcare professionals in adverse drug reaction reporting programs. Health care professionals are asked to report any suspected adverse reactions in patients receiving Serzone-5HT2 (nefazodone HCl) directly to Bristol-Myers Squibb Canada at 1-866-463-6267 or by fax at 1-888-267-6211 or to the Marketed Health Products Directorate.

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.

Any questions from health care professionals may be directed to our Medical Information department via Bristol-Myers Squibb Canada at 1-866-463-6267 or by fax at 1-888-267-6211.

Very truly yours,

original signed by

Nacia Faure, M.D.
Medical Director

Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.


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Last updated - 2003-10-22
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