Health Canada Changes Tamiflu Labeling
Posted on: Wednesday, 28 March 2007, 15:00 CDT
Health Canada has made revisions to the labeling on the influenza drug Tamiflu, manufactured by Roche, to include new safety information after recent reports of abnormal or suicidal behavior in Japanese children or teenagers taking the drug.
However, Health Canada said there have been no Canadian reports of deaths or psychiatric adverse events such as abnormal or suicidal behavior in children or teenagers.
Last week Japan restricted use of Tamiflu in patients 10 to 19 years old and there were eight new cases reported in Japan of self-harm in patients taking Tamiflu. However, the connection with the drug in these new cases has not been proven and high fever or other complications from influenza can affect patients' mental state.
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 regulatory body said that further information is expected from the manufacturer, Hoffman-LaRoche, and appropriate measures will be taken if necessary following analysis.
Source: Datamonitor
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