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Influenza Vaccine

Roche to revise Tamiflu label in U.S. to include reports of neuropsychiatric events

Published in Medical Letter on the CDC and FDA, December 24th, 2006

Tamiflu (oseltamivir phosphate) was demonstrated in clinical trials to be a safe and effective medication for influenza prevention and treatment. Tamiflu was approved in 1999 and has been used by more than 42 million people in over 80 countries.

Roche continuously reviews post-marketing safety information and provides regular updates to the regulatory agencies. Based upon reports received over the last influenza season, Roche has agreed that the Tamiflu label in the U.S. will be revised to include reports of neuropsychiatric events such as self-injury and delirium in patients with influenza. Reports of neuropsychiatric events in patients taking oseltamivir are very rare...

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