The safety of oseltamivir in pregnancy: an updated review of post-marketing data†

Purpose Influenza infection places pregnant women at greater risk of morbidity and hospitalization. The use of oseltamivir to treat influenza increased markedly in all population groups during the A/H1N1pdm09 pandemic, including pregnant women. Given this increase in exposure, a reassessment of the safety of oseltamivir in pregnancy was conducted. Methods The Roche Global Safety Database was searched for all exposures to oseltamivir during pregnancy in the 13 years up to 30 April 2012. Results Of the 2926 maternal exposures to oseltamivir retrieved from the Safety Database, pregnancy outcomes were known for 2128 women. Most exposures (>90%) were reported during or after the pandemic. The incidence of adverse pregnancy outcomes in exposed women was: spontaneous abortions, 2.9% (61/2128); therapeutic abortions, 1.8% (39/2128); and pre-term deliveries, 4.2% (84 of 2000 live births), values which are lower than background rates in the general population (women with or without influenza). Fetal outcomes were known in 1875 of the 2926 exposures. For the 81 reported birth defect cases, 11 occurred during the sensitive period for the respective defects. A review of these and other case reports of birth defects did not suggest that they resulted from oseltamivir exposure. Conclusions The data reviewed in this article reinforce the findings of a previous review, suggesting that oseltamivir is unlikely to cause adverse pregnancy or fetal outcomes. Copyright © 2014 John Wiley & Sons, Ltd.