Prescribing drugs in pregnancy is an unusual risk-benefit situation. Drugs that may be of benefit or even life-saving to the mother can deform or kill the fetus. However, the risk to the fetus should not be exaggerated. There are only approximately 20 drugs or groups of drugs which are known to cause birth defects in humans. For one of these drugs to cause birth defects, a number of criteria must be fulfilled. The drug exposure must take place at a critical stage of pregnancy and the dose must be high enough to cause a threshold of exposure for an appropriate duration of time.
For most of the known human teratogens, more than 90% of pregnancies exposed during the first trimester result in normal offspring. Although only a few drugs are known to cause birth defects in humans, uncertainty about the safety of the majority may lead to under prescribing for pregnant women and women of childbearing age. Epidemiological studies of pregnancy outcome after specific drug exposures are often superficially reassuring, but most are severely limited in their power to detect adverse outcomes.
Safety in animal studies may also be reassuring but species differences demand caution in this interpretation. Concerns about prescription drugs in the first trimester, when they can cause birth defects, are mostly quite different to concerns about use in the second and third trimesters. As the fetal organ systems mature, the fetus can be affected by the pharmacological activity of the drug in the same way as the mother. Many drugs have pharmacological effects on the fetus in the second and third trimesters but in most cases, they are well recognized and can be managed or avoided. The material presented in this paper is mostly concerned with the ‘risks’ associated with drugs in pregnancy. No attempt has been made to quantitate the possible benefits to the mother or fetus. Communicating the risk-benefit situation to the patient is always a challenge for physicians with limited time and sometimes limited knowledge. Fear of litigation is an unfortunate and an unwanted parameter in the assessment. Better knowledge of the parameters that determine teratogenicity may allow physicians to feel more confident in assessing the risks and benefits associated with prescribing in pregnancy.