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

Yael Waknine


November 14, 2006

Editor's note: According to an alert sent on January 4, 2007, from MedWatch, the the FDA's safety information and adverse event reporting program, the prescribing information that accompanied the original letter from Roche contained an incorrect dosing chart for the standard dose of oseltamivir for prophylaxis of influenza in pediatric patients. The dosing frequency should have been listed as once daily instead of twice daily under the "Recommended Dose for 10 days" column. In a new letter, Roche advises clinicians to discard the original chart and refer to the corrected one for dosing information.

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.

Adverse events potentially related to use of oseltamivir should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.


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