Roche Holding's Tamiflu and GlaxoSmithKline's Relenza, the two most common drugs used to treat the flu, should carry revised warnings about a risk of psychiatric side effects, a U.S. panel said.
The committee of outside advisers to the Food and Drug Administration decided today that prescribing information doesn't adequately explain the delirium, hallucinations and psychotic behavior reported by hundreds of patients in Japan and the U.S. since the medicines came on the market in 1999. Tamiflu added a precaution about these risks last November, and regulators have identified similar reports in Relenza patients since then.
Tamiflu sales have fallen since the FDA first raised safety concerns two years ago. The new prescribing information should say the side effects are rare and may also occur in patients with influenza who aren't taking Tamiflu or Relenza, members of the advisory panel said.
``It involves certain behaviors and activities that in either case, the public may need to be more aware of and watch more closely,'' panel member Michael Fant, an associate professor at the University of Texas-Houston Medical School, said today at a meeting in Gaithersburg, Maryland.
``Anything that elevates awareness is probably not a bad call.''
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