Information Update - Health Canada examining information linking antiviral drug to development of treatment-resistant HIV

    OTTAWA, Feb. 21 /CNW Telbec/ - Health Canada is informing Canadians of
new information submitted by the manufacturer of the antiviral drug Baraclude
that suggests the drug may be linked to the development of a
treatment-resistant strain of HIV in one patient with HIV.
    Baraclude (the brand name for the drug entecavir) has been authorized in
Canada since June 2006 for the treatment of active chronic infection with
Hepatitis B virus in adults. This new information consists of a U.S. report of
a patient, infected with both HIV and Hepatitis B virus, whose HIV infection
became resistant to one of the more commonly used HIV treatment drugs while
the individual was taking only Baraclude. In addition, this is one of three
U.S. reports submitted by the manufacturer, Bristol-Myers Squibb Canada,
concerning HIV patients who experienced a decrease in their HIV virus levels
while using Baraclude, despite not being treated with HIV drugs. To date,
studies of Baraclude do not suggest that the drug has any activity against
HIV. Drugs which have activity against HIV may be associated with increased
risk of developing treatment-resistant forms of HIV.
    Health Canada is following up on this information and will provide
Canadians with any new safety recommendations which may be warranted for the
use of Baraclude when the review is completed.
    Canadians taking Baraclude should consult with their physician if they
have any questions or concerns.
    Consumers requiring more information about this Information Update can
contact Health Canada's public enquiries line at [phone], or toll free
at 1-866-225-0709.
    Any serious or unexpected adverse reactions in patients receiving
Baraclude or any other drug should be reported to the Canadian Adverse Drug
Reaction Monitoring Program (CADRMP) of Health Canada by one of the following
methods:

    Telephone: [phone]
    Facsimile: 1-866-678-6789

    CADRMP
    Marketed Health Products Directorate
    Tunney's Pasture, AL 0701C
    email: [e-mail]

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

    Egalement disponible en français

For further information: Media Inquiries: Alastair Sinclair, Health
Canada, [phone]; Public Inquiries: [phone], 1-866 225-0709