Abstract

To evaluate safety of oseltamivir in neonates with significant comorbidities in a level-III neonatal intensive care unit during an outbreak of 2009 H1N1 influenza. We performed a retrospective chart review of neonates who received oseltamivir for treatment and prophylaxis of influenza during the outbreak. A total of 11 neonates received twice daily dosing and 21 neonates received once daily dosing (12 to 25 mg per dose) for treatment and prophylaxis of influenza, respectively. Age ranged from 2 days to 11.4 months (mean, 2.1 months). Corrected gestational age and weight at initiation of oseltamivir ranged from 32 to 86 weeks (mean, 41 weeks) and 775 to 8635 g (mean, 3074 g), respectively. All had complex underlying conditions. Oseltamivir was well tolerated. Neurologic adverse effects or mortality attributable to oseltamivir were not identified. Mild rash and gastrointestinal signs in four infants resolved without oseltamivir discontinuation. Three showed a transient rise in transaminases; all returned to baseline after completing therapy. Oseltamivir appears to be well tolerated in preterm and term neonates and infants with complex underlying conditions. More studies are needed to determine optimal dosing for treatment and prophylaxis in this vulnerable age group.

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