The new language lists seizures, hallucinations and delirium as among the problems seen in patients taking the drug. The Food and Drug Administration highlighted the changes in a posting to its website.

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Most problems occurred in Japanese children taking the drug.

Japan is the largest market in the world for flu medications because doctors there prescribe drugs like Relenza as a standard treatment for flu symptoms.

New label claims no casual link
The new Relenza label stresses that there is no causal link between Relenza and the psychiatric problems.

London-based Glaxo alerted doctors to the changes in a letter last month, which the FDA posted to its website.

Swiss drug maker Roche made similar changes to the label for its drug Tamiflu last month. Tamiflu was the top-selling flu medication worldwide last year with sales of $2.4 billion. Relenza had sales of $520 million. – (Sapa)

April 2008

Read more:
Flu drugs losing punch

 

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