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    Medication Adverse Event Alert November 14, 2006 MEDICATION: OSELTAMIVIR PHOSPHATE
The following FDA Medwatch was released on November 13, 2006: "Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, 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." Recommendations: The current available data suggest that if self-injury or confusion occurs after oseltamivir treatment, it is more likely to do so in pediatric patients. Since these neuropsychiatric events have been from postmarketing reports (mostly from Japan), the relative contribution of the drug is not known. As indicated, patient with influenza treated with oseltamivir should be closely monitored for signed of abnormal behavior throughout the treatment period.
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