Flu drugs and neuropsychiatric changes.

The FDA’s Pediatric Advisory Committee has recommended changing the label of Roche’s flu medication Tamiflu to 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 including an indication that the adverse events are sometimes fatal and adding 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.

Last year, Roche revised its Tamiflu package insert to add warnings about the potential for self-injury and confusion, particularly in pediatric patients. Twenty-five patients younger than 21 years old have died while taking Tamiflu, with 21 of the cases occurring in Japan and three in the U.S. Five of the deaths came from children “falling from windows or balconies or running into traffic,” the FDA said.

Source: FDA News