Potential Risk of Serious Adverse Health Consequences with Inadvertent Administration of Cesamet (nabilone) Capsules 1 mg Instead of Trazorel (trazodone hydrochloride) Tablets 50 mg Due to Mislabelling - For Health Professionals

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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 Valeant Canada Limited.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on Cesamet Capsules 1 mg and Trazorel Tablets 50 mg

October 21, 2009

POTENTIAL RISK OF SERIOUS ADVERSE HEALTH CONSEQUENCES WITH INADVERTENT ADMINISTRATION OF CESAMET (nabilone) CAPSULES 1 MG INSTEAD OF TRAZOREL (trazodone hydrochloride) TABLETS 50 MG DUE TO MISLABELLING

Subject: URGENT - TYPE I PRODUCT RECALL NOTICE

Dear Health Care Professional,

Product	Strength	DIN	Package Type	Lot Numbers for both products
CESAMET	1 mg	00548375	Bottles of 50 capsules	9D9875 Expiry date: 2011/03 9E0077 Expiry date: 2011/05 9G0282 Expiry date: 2011/05 9G0283 Expiry date: 2011/07 9G0362 Expiry date: 2011/08
TRAZOREL	50 mg	02230284	Bottles of 100 tablets

^NCESAMET^® (nabilone) is a synthetic cannabinoid with antiemetic properties which have been found to be of value in the management of some patients with nausea and vomiting associated with cancer chemotherapy^[1]. Trazorel (trazodone hydrochloride) is a psychoactive compound with sedative and antidepressant properties and is of value in the symptomatic relief of depressive illness^[2].

Due to a mislabelling incident, a bottle containing CESAMET CAPSULES 1 MG bearing one of the lot numbers and expiration dates in the above table was labelled as TRAZOREL 50 MG TABLETS.

For this reason, Valeant Canada Limited, in consultation with Health Canada, is advising healthcare professionals of a recall involving CESAMET 1 mg Capsules (bottles of 50 capsules) and TRAZOREL 50 mg Tablets (bottles of 100 tablets), with the above lot numbers and expiration dates.

A similar notice has been forwarded to all wholesalers distributing for Valeant Canada Ltd.

Patients taking either of these medications have been provided with the description and pictures of the two involved products through a public warning and are being advised to check their prescription bottles immediately to ensure that they contain the correct product. If not, they have been advised to contact their treating physician immediately and return the product to the pharmacy. Trazorel comes in round, peach-colored tablets engraved with ICN T21. Cesamet is sold in blue and white capsules with the number 3101 imprinted on the white part of the capsule and the ICN logo on the blue part of the capsule. Please see pictures of the two products on the last page of this letter.

The following is recommended:

The most important medical risks of inadvertently taking nabilone instead of trazodone are:

• The usual daily maintenance dose of trazodone is 300 mg divided in 2-3 doses per day. As a consequence, due to this mislabelling, the patient might take 6 capsules of nabilone 1 mg (believing it to be trazodone) totalling 6 mg/day instead of 6 tablets of trazodone 50 mg divided in 2-3 doses per day. The maximum recommended daily dose of nabilone is 6 mg in divided doses (twice a day). Therapy with nabilone requires dose adjustment for the purposes of response and tolerance in individual patients. Symptoms of overdose such as hallucinations, anxiety reactions or respiratory depression may occur if a patient is exposed acutely to 6 mg of nabilone in divided doses without dose adjustment. Also accidental exposure to nabilone 6 mg increases the risk of developing psychotropic reactions that can persist for 48 to 72 hours following cessation of treatment.
• The most frequently observed adverse reactions to nabilone are: drowsiness, vertigo, euphoria, dry mouth, depression, ataxia, blurred vision and dysesthesias. A depressed patient taking nabilone instead of his (her) usual antidepressant treatment is susceptible to becoming more depressed given the potential for depression associated with nabilone.
• Nabilone is contraindicated in patients with known sensitivity to cannabinoids or history of psychotic reactions.

Reporting Adverse Events
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 postmarketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving the identified lot numbers mentioned in the table should be reported to Valeant Canada Ltd. or Health Canada at the following addresses:

Valeant Canada Ltd.
4787 Levy Street
Montreal
Quebec H4R 2P9
Toll-free Number: 1-800-361-4261

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701D
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction 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:
Health Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

original signed by

Mirela Baranci, MD
Director
Medical and Regulatory Affairs
Valeant Canada Ltd.

Cesamet 1 mg capsules

Trazorel 50 mg tablets

References

1. Cesamet, Canadian Product Monograph. March 17, 2009; page 2.
2. Trazorel, Canadian Product Monograph. Revision March 23, 2009; pages 2-3.