US FDA to review drugs' effects on children
Following a request in 2005 by the US Food and Drug Administration's Pediatric Advisory Committee for the agency to conduct a comprehensive review of the neuropsychiatric events with antivirals for influenza, the FDA has now released its review, which includes Roche's Tamiflu (oseltamavir) and GlaxoSmithKline's Relenza (zanamivir). It has also suggested that labeling for the products be amended.
FDA researchers are also questioning the pediatric safety of GSK's asthma drugs Serevent and Advair
The Advisory panel was due to start reviewing the data on November 27.
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