DMAThis article escape people's attention. There is not going to...

DMA

This article escape people's attention. There is not going to be labelling warning change in my humble opinion.


Cheers


http://triangle.bizjournals.com/triangle/stories/2007/11/26/daily23.html

"GSK was pleased have the opportunity to present safety information on Relenza to the Pediatric Advisory Committee showing no conclusive evidence of a causal association between Relenza and neuropsychiatric events," the company said in a statement e-mailed to reporters this morning. "We believe the current Relenza U.S. prescribing information accurately reflects the safety profile of the drug. The Committee acknowledged that there are neuropsychiatric complications associated with influenza infection and that information should be communicated to healthcare providers. We expect to discuss the Committee's decision with FDA and ensure that all information is updated, as appropriate."