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Roche Happy To Change Tamiflu Label

Written by Stuart Stevens | Wednesday, 28 November 2007 | There are 0 comments

50 million people have used the influenza drug Tamiflu

Just yesterday we reported that the Safety Review Panel of the Food & Drug Administration of the United States of America had said that it would be recommending that the labelling of the Tamiflu influenza medication should be changed to include information about the extremely rare side effect of hallucination and delirium.

Roche Happy To Change Tamiflu Label

The good news is that the manufacturer of Tamiflu namely Roche Holding AG has no objection to including the recommendation of the Safety Review Panel and is happy to put a stronger worded warning on its labels that accompany the Tamiflu influenza drug. A spokesman from Roche however noted that the influenza virus could actually in itself cause problems of a psychiatric nature and that patients should be made aware of this also. Roche said that no casual relationship between the psychiatric problems and Tamiflu had actually been proven and therefore they felt that the label should include that the influenza virus can on its own trigger a psychiatric event.

It is estimated that almost 50 million people have used the Tamiflu influenza drug since it was launched by Roche in 1999 and the labelling for the drug already mentions the fact that in extremely rare cases people have reported delirium especially among young Japanese children.  Almost 600 cases of psychiatric incidents have been reported by people taking Tamiflu and 450 of them came from Japan. In the worst cases five children were said to have died after falling out of high buildings according to the reports received by the FDA in America.

In view of the fact that 50 million people have used the influenza drug and influenza in any case can trigger psychiatric problems Roche have an argument when they say that there is no proven link between the two. Roche said that having looked at tens of thousands of individual cases of influenza they believe that the information received shows that the influenza itself is a far more likely cause of the hallucinations and delirium than the Tamiflu drug.

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