Pediatric Advisory Committee Recommends Labeling Changes for Flu Drugs

The FDA’s Pediatric Advisory Committee voted 9–5 to recommend changing the label of Roche’s flu medication Tamiflu to better reflect the potential for neuropsychiatric adverse events, but it did not specify what changes should be made.

The relationship between Tamiflu (oseltamivir phosphate) and neuropsychiatric adverse events, including suicides, cannot be determined, the FDA said. Committee members proposed changes including indicating that the adverse events are sometimes fatal and language showing the uncertainty over the drug’s causal effect.

The committee also voted to change the labeling of GlaxoSmithKline’s (GSK) Relenza (zanamivir) to reflect an increase in adverse event reports but did not determine what the changes should be or whether the label should be the same as Tamiflu’s.

Roche has not identified any increased risk of neuropsychiatric adverse events in patients taking Tamiflu compared with those not taking the drug, the company’s Drug Safety Risk Management Director Jonathan Solsky said. Tamiflu’s current labeling continues to reflect all available data and should not change, he added.

The advisory committee reviewed GSK’s Relenza due to a sharp increase in reported psychiatric adverse events with the drug after the last flu season. No neuropsychiatric adverse events were reported in the 2004-2005 and 2005-2006 flu seasons, but 75 were reported in the 2006-2007 season, Adrienne Rothstein, safety evaluator for the Office of Surveillance and Epidemiology (OSE), said. No deaths were reported with the drug.