Archived – Changes to Canadian labelling of Tamiflu

Starting date:

March 27, 2007

Posting date:

March 27, 2007

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Labelling and Packaging

Audience:

General Public

Identification number:

RA-110001909

• Media enquiries
• Public enquiries

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
email: 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.

Media enquiries

Alastair Sinclair
Health Canada
(613) 957-1803

Public enquiries

(613) 957-2991
1-866 225-0709