Obtaining further information on the fetal and infant effects of maternal medication

Abstract All too often the pregnant or breastfeeding mother is told that she cannot receive a drug because the manufacturer has advised against its use. Such information is usually derived from the Summary of Product Characteristics and frequently reflects a lack of information of such use during the early stages of drug development and licensing. These statements are always cautious, seldom very informative, and often merely designed to meet the minimum requirement laid down by the licensing authority. While there are a small number of drugs whose use during pregnancy and lactation is extremely unwise, for most drugs it is more a matter of balancing the advantages and the disadvantages. Information from pregnancy and lactation databases increasingly supplements the information from animal teratogenicity and toxicology studies. Prescribers must consider both disease and drug characteristics when making decisions on medication use during both pregnancy and lactation. They can then use this information to balance the risks of fetal or neonatal exposure against the potential benefits of maternal treatment and the risks of untreated disease. This section allows the reader to quickly look up such risks and, through the references, examine the primary literature to help the mother make an informed choice.