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news.A European regulatory panel has decided Roche's Tamiflu does not require labeling changes in what was the conclusion to a drug review triggered by fears Tamiflu could be linked to psychiatric disorders.
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The review of the flu vaccine came after the deaths of 12 children in Japan who had been taking Tamiflu. The European Medicines Agency ruled the treatment could not be linked to the deaths and that no changes to the drug’s labeling would be required. A similar decision was reached by US authorities last month.
In addition, both European and Swiss authorities have issued positive opinions for Roche’s vaccine for the prevention of influenza in children aged one to 12 years.
Tamiflu is already indicated for the treatment of influenza in adults and children aged one year and above and for the prevention of influenza in adults and adolescents 13 years and older. A filing for Tamiflu for preventative use in children was submitted in the US in April 2005 and an approval is expected early 2006.
Tamiflu is a highly effective influenza drug that works by blocking an enzyme on the surface of the virus which prevents it infecting other cells in the body.