A U.S Food and Drug Administration panel will review recommendations that psychiatric warnings be added to the labels of Roche Holding AG's Tamiflu and GlaxoSmithKline's Relenza.
The recommendation includes adding label warnings be increased on Tamiflu to include "in some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients." FDA staff would also like the Relenxa box label to include:"reports of hallucinations, delirium and abnormal behavior" seen in some patients taking the drug.
At this point FDA staff is unsure whether it is the drugs causing the adverse events or if they are a manifestation of a disease or a combination of the two. Roche has stated that there is no causal relationship between the psychiatric events and Tamiful. "Roche has extensively investigated the issue and is conducting ongoing clinical and nonclinical studies. Roche takes all adverse events reports very seriously," spokesman Terence Hurley said in a statement. A GlaxoSmithKline spokesperson also stated that no evidence of these types of adverse events in post-approval trial data.
The documents for advisory meeting were posted at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b-00-in dex-27and28.html .
[Source: YahooNews]
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