Tamiflu (oseltamivir phosphate) Capsules and for Oral Suspension

January 2, 2004

Audience: Pediatricians, Primary Care Providers, and other Healthcare professionals

Roche Laboratories and FDA notified healthcare professionals of new preclinical safety data that have implications for the use of Tamiflu in very young children. Preclinical findings in juvenile rats have raised concerns regarding the use of Tamiflu in infants less than 1 year of age. A single dose of 1000 mg/kg oseltamivir phosphate (about 250 times the recommended dose in children) in 7-day-old rats resulted in deaths associated with levels of oseltamivir phosphate in the brain approximately 1500 times those seen in adult animals. It is likely that these high exposures are related to an immature blood-brain barrier. The clinical significance of these preclinical data to human infants is uncertain. Given the uncertainty in predicting the exposures in infants with immature blood-brain barriers, it is recommended that Tamiflu not be administered to children younger than 1 year.

[December 2003 Letter - Roche Pharmaceuticals]
[October 2001 Package Insert - Roche Pharmaceuticals]

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