Prescribing of medicines during pregnancy is common, and for some groups of women is essential for maintaining maternal and therefore fetal health. Pregnant women and prescribers are rightly concerned, however, about the potential adverse fetal effects of medicines. These may include fetal death or stillbirth, congenital malformations, developmental impairment, neonatal effects or late carcinogenesis. It is therefore essential that the risks and benefits for mother and fetus are considered carefully before prescribing in pregnancy. This is often challenging because of the paucity of information available. To complicate the issue further, drug pharmacokinetics are commonly altered in pregnancy, potentially affecting optimal dosing as well as interpretation of plasma concentration measurements, with specific information on individual drugs seldom available. Most drugs cross the placenta, especially lipophilic drugs and those with low plasma protein binding. Active membrane transporters also have an important role in enhancing or preventing drug transfer, although this is not yet clearly understood. Animal studies have limited applicability to humans because of species-specific effects, and clinical trials in pregnancy are only undertaken in special circumstances. Prescribers therefore need to rely on observational studies of fetal outcomes following drug exposure in human pregnancy. These often involve limited numbers, and data are also subject to confounding and bias, making interpretation difficult. It therefore remains essential that appropriate mechanisms for systematic data collection, including congenital malformation registries, teratology information services, pregnancy registers and linked population registries, are maintained and enhanced to increase the amount and quality of information available.
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.