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FDA Panel Backs Tougher Warning for Tamiflu
Date:11/27/2007

lso concerned that the public might overreact.

"I am not a fan of replacing fear of a disease with fear of the treatment for the disease," said Siegel, speaking before the advisory panel met. "You don't need to go from one panic to another."

Tamiflu is overused, however, Siegel added. "It's supposed to be used in a very narrow window, and I am not surprised that there have been psychiatric side effects related to this drug," he said. "Maybe the new warning will lead to less overuse."

Tamiflu is approved both as a preventive and a treatment for flu for adults and children aged 1 year and older.

Relenza is approved as both a flu preventive and a treatment in adults and children aged 5 years old and older.

GlaxoSmithKline, the British maker of Relenza, doesn't believe the label needs changing. "The review and analysis of all the information available in this safety summary of neuropsychiatric events does not implicate or indicate a significant causal role of zanamivir. Therefore, no revisions are warranted for the U.S. Prescribing Information and the FDA-approved Patient Labeling for Relenza," the company told the FDA.

More information

For more on the flu, visit the U.S. Centers for Disease Control and Prevention.



SOURCES: Marc Siegel, M.D., clinical associate professor, medicine, New York University School of Medicine, New York City; Pediatric Safety Update for Tamiflu, Division of Antiviral Products, U.S. Food and Drug Administration; statements, GlaxoSmithKline and Hoffmann-La Roche Inc.; Bloomberg news; Associated Press


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