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. 2018 Oct 16;18(1):519.
doi: 10.1186/s12879-018-3423-z.

Oseltamivir in pregnancy and birth outcomes

Vera Ehrenstein  1 , Nickolaj Risbo Kristensen  2 , Brigitta Ursula Monz  3 , Barry Clinch  4 , Andy Kenwright  4 , Henrik Toft Sørensen  2
Affiliations

Oseltamivir in pregnancy and birth outcomes

Vera Ehrenstein et al. BMC Infect Dis. .

Abstract

Background: Prenatal exposure to influenza or fever is associated with risk of congenital malformations. Oseltamivir is used to treat influenza and to provide post-exposure prophylaxis. We examined the association between oseltamivir use during pregnancy and birth outcomes.

Methods: This was a nationwide registry-based prevalence study with individual level data linkage, in a setting of universal health care access. We included all recorded pregnancies in Denmark in 2002-2013, and used data from population registries to examine associations between dispensings for oseltamivir during pregnancy (first trimester, second/third trimester, none) and congenital malformations, foetal death, preterm birth, foetal growth, and low 5-min Apgar score. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were computed using propensity score matching.

Results: The study included 946,176 pregnancies. Of these, 449 had first-trimester exposure and 1449 had second/third-trimester exposure to oseltamivir. Adjusted ORs following first-trimester exposure were 0.94 (95% CI 0.49 to 1.83) for any major congenital malformation and 1.75 (95% CI 0.51 to 5.98) for congenital heart defects, based on 7 exposed cases. The association with congenital heart defects was present for etiologically implausible exposure periods and for known safe exposures. There was no evidence of an association between prenatal exposure to oseltamivir and any of the other birth outcomes assessed.

Conclusions: The study does not provide evidence of risk associated with oseltamivir treatment additional to that associated with influenza infection.

Keywords: Congenital abnormalities; Epidemiology; H1N1 influenza; Oseltamivir.

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Conflict of interest statement

Ethics approval and consent to participate

The study received a required approval by the Danish Data Protection Agency [record numbers 2015-57-0002 (previously 2015-41-3838) and 2013-41-1754]. The study protocol is registered as Post-Authorisation Safety Study with the ENCePP Register of Studies, with study number EUPAS12875 (Roche identifier: BV29684). There is no requirement by Danish law to obtain informed consent or an approval by an Institutional Review Board for a registry-based study.

Consent for publication

Not applicable.

Competing interests

BM, BC and AK are full-time employees and hold stock and/or stock options in Roche, the manufacturer of oseltamivir. VE, NRK, and HTS are salaried employees of Aarhus University/Aarhus University Hospital. HTS is supported by the Program for Clinical Research Infrastructure (PROCRIN), established by the Lundbeck Foundation and the Novo Nordisk Foundation and administered by the Danish Regions. This study was funded by F. Hoffmann-La Roche Ltd. through a research agreement to and administered by Aarhus University.

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Figures

Fig. 1
Fig. 1
Identification of pregnancies beginning and ending in 2002–2013, Denmark
See this image and copyright information in PMC

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