[NPInfo] FDA News

[David Mittman]

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