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Review
. 2018 Feb;84(2):215-222.
doi: 10.1111/bcp.13438. Epub 2017 Oct 22.

Inclusion of pregnant and breastfeeding women in research - efforts and initiatives

Sílvia M Illamola  1 , Christina Bucci-Rechtweg  2 , Maged M Costantine  3 , Ekaterini Tsilou  4 , Catherine M Sherwin  1   5 , Anne Zajicek  4
Affiliations
Review

Inclusion of pregnant and breastfeeding women in research - efforts and initiatives

Sílvia M Illamola et al. Br J Clin Pharmacol. 2018 Feb.

Abstract

Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and -dynamic understanding of medication use in pregnancy.

Keywords: breastfeeding; clinical pharmacology; drug utilization; obstetric; pregnancy.

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Figures

Figure 1
Figure 1
Evolution of regulations related to pregnancy drug development over the time. FDA, US Food and Drug administration; NIH, National Institutes for Health; PLLR, pregnancy and lactation labelling rule
See this image and copyright information in PMC

References

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MeSH terms

Substances