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Tamiflu Label Updated with Neuropsychiatric Warning

The revised label adds a warning about possible neuropsychiatric side effects.

The FDA and Roche Laboratories have revised the product label for Tamiflu (oseltamivir phosphate) to include a warning about possible neuropsychiatric events. The updated label is based on recommendations from the agency’s Pediatric Advisory Committee meeting in November 2007.

Postmarketing reports indicate that some patients with influenza who were receiving Tamiflu had delirium and abnormal behavior, leading to injury and even death. Most of the cases occurred in children and in Japan.

Although it's not clear whether Tamiflu caused these events, the label cautions clinicians to monitor their patients for abnormal behavior when taking the drug. Adverse events should be reported through the FDA’s MedWatch site.

Published in Journal Watch Pediatrics and Adolescent Medicine March 12, 2008
Originally published in Physician's First Watch March 5, 2008