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FDA Votes Marginally In Favour Of Extra Tamiflu Warning

Written by Stuart Stevens | Thursday, 03 January 2008 | There are 0 comments

Tamiflu is the most popular influenza drug in the world

The Food & Drug Administration of America has voted that the manufacturer of Tamiflu (Roche) should change the wording of the warning labels for the influenza drug after concerns that the drug could cause psychiatric problems. The panel of scientists who were asked to look at the cases of psychiatric problems voted the only marginally in favour of a wording change, in fact eight voted in favour and six voted against the recommendation.

FDA Votes Marginally In Favour Of Extra Tamiflu Warning

Tamiflu is the most popular influenza drug in the world and is heavily used in Japan where most of the reported cases of psychiatric problems and hallucinations have occurred. In fact Japan is responsible for 2/3 of the worldwide Tamiflu consumption.  A recent government sponsored research project to look into psychiatric problems with taking Tamiflu in Japan could find no definite link to the drug and the researchers noted that the influenza virus is known to aggravate any existing psychiatric problems on its own meaning that it was very likely that the Tamiflu was not to blame at all.

There was a lively discussion concerning the recommended wording change for the Tamiflu drug at the FDA and some of the panel said that it would be a good step to point out on the labeling that some patients have died due to abnormal behaviour when suffering from flu and when not using the Tamiflu drug. At present the Tamiflu drug’s labeling notes that in very rare cases Tamiflu patients have suffered from self injury and delirium.

The Roche drug company said that they have examined evidence of over 150,000 Tamiflu users and could find no evidence of a larger risk of mental illness or psychiatric problems with its use. The Food & Drug Administration is likely to follow the recommendations of the panel evaluating the Tamiflu psychiatric cases but is not legally bound to do so.

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