US FDA panel calls for label revisions on Tamiflu and Relenza

A US Food and Drug Administration advisory panel has voted in favor of stronger warnings relating to rare, but often serious, psychiatric side effects in people using influenza drugs, notably Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir).

The panelists agreed, by eight to six, that all antiviral drugs that are approved to treat flu should have similar labels regarding serious adverse neuropsychiatric events and that the incidence is very rare, although sometimes fatal. Most such cases were reported in Japan. They also recommended that labels should reflect uncertainty regarding any causal relationship between antiviral therapy and such events. Several of the advisors suggested that the labeling should note that similar deaths have occurred in people not taking the antivirals.