Abstract
Medicine use in pregnancy is extremely common, but there are significant knowledge gaps surrounding the safety, dosage and long-term effects of drugs used. Pregnant women have been purposively excluded from clinical trials of the majority of treatments for conditions that may occur concurrently with pregnancy. There is minimal information on the pharmacokinetics of many existing treatments and no systematic capture of long-term outcome data to help inform choices. Treatments commonly used in pregnancy are thus often old and untested, not optimised in dose, and prescribed off-label without adequate safety information. In addition, there has been a staggering lack of investment in drug development for obstetric conditions for decades. This is a major public health concern, and pregnancy complications are the leading cause of mortality in children under five years old globally, and health in pregnancy is a major determinant of women’s long-term health and wellbeing. There is an acute need for adequate investment and legislation to boost inclusion of pregnant women in clinical studies, capture high-quality information on medication use in pregnancy in general, and encourage new medicinal product development for obstetric conditions.
Highlights
In high-income countries, four out of five pregnant women are prescribed one or more medications in pregnancy[1], and even higher levels of pregnant women self-medicate with over-thecounter preparations[2]
In the US, the Treating for Two initiative of the Centers for Disease Control and Prevention aims to improve both the evidence base and guidance for safer medication use in pregnancy to inform decision making[36] while the Obstetric-Fetal Pharmacology Research Centers Network supported by the National Institute of Child Health and Human Development aims to improve the understanding of obstetric pharmacokinetics and pharmacodynamics through non-clinical, clinical and pharmacokinetic and pharmacogenetic studies[37]
Studies consistently show that the majority of pregnant women are prescribed one or more medications in pregnancy, rates are 50 to 80% depending on the setting, and when over-the-counter treatments are included rates approach 100%1,40–43
Summary
Faculty Reviews are review articles written by the prestigious Members of Faculty Opinions. The articles are commissioned and peer reviewed before publication to ensure that the final, published version is comprehensive and accessible. The reviewers who approved the final version are listed with their names and affiliations. Keywords Pregnancy, Pharmacokinetics, Pharmacovigilance, Medicines, Public Health, Maternal Health, Newborn Health, Child Health, 2. David Olson, University of Alberta, Edmonton, Canada. Any comments on the article can be found at the end of the article
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