Oseltamivir Safe in Pregnancy

Short Attention Span Summary

Oseltamivir doesn't make baby grow 3 eyes
This was a large Scandinavian population study that found no increased incidence of adverse neonatal outcomes, including congenital malformations, in fetuses exposed to ostetamivir in utero, even if in the 1st trimester.  Influenza is particularly dangerous during pregnancy, so it's good to know that oseltamivir can be used safely.

I would be remiss not to mention the controversy swirling around this drug.  There are some who say there is no role for oseltamivir at all.  A recent Cochrane review found no benefit, except symptom resolution about 17 hours sooner.  But given that the CDC still recommends its use in high-risk groups, specifically pregnant or postpartum women, I will continue to use it for these patients.  And this article provides reassurance it won't cause harm during pregnancy.

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Oseltamivir was safe for use during pregnancy.




BMJ. 2017 Feb 28;356:j629. doi: 10.1136/bmj.j629.

Neuraminidase inhibitors during pregnancy and risk of adverse neonatal outcomes and congenital malformations: population based European register study.

Graner S1,2, Svensson T1, Beau AB3, Damase-Michel C3, Engeland A4,5, Furu K4, Hviid A6, Håberg SE4, Mølgaard-Nielsen D6, Pasternak B6,7, Kieler H1.

Author information:

1 Department of Medicine, Centre for Pharmacoepidemiology, Karolinska Institutet, Karolinska University Hospital, SE-17176 Stockholm, Sweden.

2 Department of Obstetrics and Gynecology, Karolinska University Hospital, SE-17176 Stockholm, Sweden.

3 Service de Pharmacologie Médicale, CHU Toulouse, Université Toulouse III, UMR INSERM, FR-1027 Toulouse, France.

4 Division of Mental and Physical Health, Norwegian Institute of Public Health, P.O. Box 4404, Nydalen, NO-0403, Oslo, Norway.

5 Department of Global Public Health and Primary Care, University of Bergen, NO-5020 Bergen, Norway.

6 Department of Epidemiology Research, Statens Serum Institut, DK-2300, Copenhagen S, Denmark.

7 Clinical epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, SE-17176 Stockholm, Sweden.


Objective To evaluate the possible effects of exposure to neuraminidase inhibitors during embryo-fetal life with respect to adverse neonatal outcomes and congenital malformations.

Design Population based multinational observational cohort study and meta-analysis.

Setting National registers covering information on maternal healthcare, births, and prescriptions in Denmark, Norway, and Sweden and the EFEMERIS database from the Haute-Garonne district in France.

Participants All women together with their singleton infants born between 1 January 2008 and 31 December 2010. Only infants born at 154 days of gestation or later were included. Infants were defined as exposed if the women filled a prescription during pregnancy for either of the two neuraminidase inhibitors oseltamivir or zanamivir.

Main outcomes Low birth weight, low Apgar score, preterm birth, small for gestational age birth, stillbirth, neonatal mortality, neonatal morbidity, and congenital malformations. Crude and adjusted hazard ratios of preterm birth were estimated using Cox regression models. Crude and adjusted odds ratios for other outcomes were estimated by logistic regression models.

Results The study included 5824 (0.8%) exposed women and their infants and 692 232 who were not exposed. Exposure to neuraminidase inhibitors in utero was not associated with increased risks of any of the investigated neonatal outcomes, including low birth weight (adjusted odds ratio 0.77, 95% confidence interval 0.65 to 0.91), low Apgar score (adjusted odds ratio 0.87, 0.67 to 1.14), preterm birth (adjusted hazard ratio 0.97, 0.86 to 1.10), small for gestational age birth (adjusted odds ratio 0.72, 0.59 to 0.87), stillbirth (adjusted odds ratio 0.81, 0.51 to 1.30), neonatal mortality (adjusted odds ratio 1.13, 0.56 to 2.28), and neonatal morbidity (adjusted odds ratio 0.92, 0.86 to 1.00). No increased risk of congenital malformations overall associated with maternal exposure was observed during the first trimester (adjusted odds ratio 1.06, 0.77 to 1.48). Similarly, no significantly increased risks of any of the outcomes were observed in an analysis restricted to oseltamivir alone.

Conclusions This large multinational register study found no increased risks of adverse neonatal outcomes or congenital malformations associated with exposure to neuraminidase inhibitors during embryo-fetal life. The results support previously reported findings that the use of neuraminidase inhibitors is not associated with increased risks of adverse fetal or neonatal outcomes.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PMID: 28246106