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Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.
See the MedWatch 2008 safety summary, including links
to the Dear Healthcare Professional letter and Tamiflu Prescribing
Information, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tamiflu
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[Posted 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.
[February, 2008 - Dear Healthcare Professional Letter - Roche]
[January, 2008 - Tamiflu Prescribing Information - Roche]
Previous MedWatch alert:
[November 13, 2006]
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http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tamiflu