Health Canada

Health Canada

August 16, 2007 09:00 ET

Health Canada/Information Update: New Safety Information Regarding Prexige (Lumiracoxib)

OTTAWA, ONTARIO--(Marketwire - Aug. 16, 2007) - Health Canada is currently requesting and reviewing new safety information regarding serious liver adverse events in patients using Prexige (lumiracoxib), a Cox-2 inhibitor non-steroidal anti-inflammatory drug (NSAID). Prexige is used in the treatment of osteoarthritis (OA) in adults.

The Therapeutic Goods Administration (TGA), the federal regulatory authority in Australia, recently withdrew market authorization for Prexige due to eight reports of serious liver adverse events in Australia linked to the drug, including two deaths and two liver transplants. These adverse events were primarily with use of 200 mg and 400 mg doses daily.

In Canada, Prexige was authorized for sale in November 2006 for acute and chronic treatment of the signs and symptoms of knee osteoarthritis in adults and in July 2007 for general OA in adults. The current label indicates that this drug should not be used in patients with severe liver impairment or active liver disease.

The Canadian maximum daily dose recommended is 100 mg, whereas, in Australia, the maximum daily dose recommended ranged from 100 mg to 400 mg daily. Due to safety concerns associated with all Cox-2 inhibitor drugs, there is a comprehensive post-market program for monitoring the safe use of Prexige.

Once Health Canada has reviewed the available data, new information will be made public to Canadians and Canadian health care professionals, including any resulting recommendations.

Prexige should be limited to the lowest effective dose for the shortest possible duration of treatment. Patients should consult with their doctor before making any change to their medication, or if they have any questions or concerns.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction to this health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:



Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
Email: cadrmp@hc-sc.gc.ca


The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect (www.healthcanada.gc.ca/medeffect) area of the Health Canada Web site.

Contact Information

  • Media Inquiries:
    Health Canada
    Alastair Sinclair
    613-957-1803
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709