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FDA, Roche Warn of Revisions to Precautions for Flu Drug, Tamiflu (Oseltamivir Phosphate)
BETHESDA, MD -- November 14, 2006 -- Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu (oseltamivir phosphate), indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older.
There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior.
A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.
SOURCE: Food and Drug Administration
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