Roche Statement Regarding Tamiflu U.S. Label Revision

Roche has informed healthcare
professionals that the prescribing information for Tamiflu (oseltamivir
phosphate) has been updated to reflect recommendations made by the FDA
Pediatric Advisory Committee at a November 27, 2007 meeting regarding
neuropsychiatric events. The revision is an update to a label change made
in November of 2006 and includes information that influenza itself has been
associated with a variety of neuropsychiatric events and that these reports
appear to be uncommon.


The changes to the label reflect observations from a growing body of
data, which shows no evidence of a causal relationship between Tamiflu and
the reported events. The data shows that these neuropsychiatric adverse
events also occurred in flu patients who were not taking Tamiflu. In fact,
emerging evidence suggests that influenza itself may cause neuropsychiatric
adverse events. In addition to clinical trials conducted prior to the
approval of Tamiflu by the FDA, extensive post-marketing studies have been
conducted and additional research is underway by Roche, Chugai and the
Japanese health authority.



Roche agrees that it is important that healthcare professionals and
patients know that all children with flu should be monitored, regardless of
whether they are taking an antiviral medication. If any sign of unusual
behavior is observed, a healthcare professional should be contacted
immediately.



Antivirals like Tamiflu play an important role in the prevention and
treatment of influenza. Tamiflu has been used by more than 48 million
people worldwide, including nearly 21 million children, since its approval
in 1999. Tamiflu is approved for the treatment and prevention of influenza
in patients over one year of age and is one of two antiviral medications
recommended by the CDC for the 2007-2008 influenza season.



Roche is committed to ensuring safe and appropriate use of our
medications and will continue to conduct appropriate post-marketing
monitoring and research.



For full U.S. prescribing information, please visit tamiflu.


Roche

Roche


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