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FDA Mulls Tougher Warning Label on Kids' Flu Drugs
Date:11/27/2007

proved both as a preventive and a treatment for flu for adults and children one year and older.

The FDA is also asking the committee to add a similar warning to another flu drug, Relenza (zanamivir). There have been 115 reported cases of "delirium with impulsive behavior and self-injury in which the patient expressed 'fear' and attempted to flee or expressed a desire to 'jump,' " the agency said. There were no deaths associated with Relenza, and, as with Tamiflu, 70 percent of the cases occurred in Japan.

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.

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

In addition, The FDA reviewed side effects associated with two other flu drugs Symmetrel (amantadine) and Flumadine (rimantadine). They are not recommending any label changes for these drugs.

More information

For more on 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.


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