Tamiflu May Be Linked to Risk for Self-Injury and Delirium

Wednesday, November 15th 2006

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November 14, 2006 ? The US Food and Drug Administration (FDA) and Roche Laboratories Inc have notified healthcare professionals regarding safety labeling revisions for oseltamivir phosphate (Tamiflu capsules and suspension) that warn of the potential risk for neuropsychiatric events associated with its use.

The warning was based on postmarketing reports (primarily from Japan) suggesting that patients with influenza receiving oseltamivir, particularly children, may be at increased risk for self-injury and delirium.

Although the role of the drug remains unclear, patients receiving oseltamivir should be closely monitored for signs of abnormal behavior, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Oseltamivir is indicated for the prophylaxis of influenza and treatment of uncomplicated acute illness in those who have been symptomatic for no longer than 2 days. It is approved for use in patients aged 1 year and older.

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Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.

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