Information Update - Changes to Canadian labelling of Tamiflu



    OTTAWA, March 27 /CNW Telbec/ - Health Canada wishes to inform Canadians
that the Canadian labelling for Tamiflu has recently been updated to include
new safety information resulting from adverse reaction reports of abnormal or
suicidal behaviour in Japanese children or teenagers taking Tamiflu. As of
February 28, 2007, there have been no Canadian reports of deaths or
psychiatric adverse events such as abnormal or suicidal behaviour in children
or teenagers.
    Health Canada has also received preliminary information on eight new
cases in Japan of self-harm in patients taking Tamiflu, and is aware that
Japan has now restricted use of Tamiflu in patients 10 to 19 years old.
Further information is expected from the manufacturer, Hoffman-LaRoche
Limited, and appropriate measures will be taken if necessary following
analysis.
    Health Canada is continuing to actively monitor adverse events reported
for Tamiflu and will consider the results of the recently announced Japanese
review of Tamiflu's safety when available. The connection with the drug in
these new cases has not been proven. High fever or other complications from
influenza can affect mental state, which in turn can lead to abnormal
behaviour.
    Canadians taking Tamiflu should consult with their physician if they have
any questions or concerns about its use.
    Consumers requiring more information about this Information Update can
contact Health Canada's public enquiries line at (613) 957-2991, or toll free
at 1-866-225-0709.
    Any serious or unexpected adverse reactions in patients receiving Tamiflu
should be reported to 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
    Tunney's Pasture, AL 0701C
    Ottawa, ON

    E-mail: cadrmp@hc-sc.gc.ca

    The CADRMP adverse reaction reporting form, including a version that can
be completed and submitted online, is located on the MedEffect portal of the
Health Canada Web site.

    Egalement disponible en français




For further information:

For further information: Media Inquiries: Alastair Sinclair, Health
Canada, (613) 957-1803; Public Inquiries: (613) 957-2991, 1-866 225-0709


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