Objective: To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Data Sources: Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Study Selection and Data Extraction: Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Data Synthesis: This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Conclusions: Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.
Bibliographical noteFunding Information:
Effective June 30, 2015, the US Food and Drug Administration (FDA) implemented a new product labeling system for medication safety in pregnancy.1The use of previously assigned pregnancy categories (A, B, C, D, X) is no longer supported by the FDA. The primary rationale for eliminating the pregnancy categories was based on stakeholder feedback to the FDA. In the final rule, it is stated that “the pregnancy categories were confusing and did not accurately and consistently communicate differences in degrees of fetal risk.” In addition, pregnancy categories were heavily relied on but often misinterpreted, without taking into account the underlying information and data.2The 3 new required narrative sections (“Pregnancy,” “Lactation,” and
© 2018, The Author(s) 2018.
- lactation/drug effects
- pregnancy/drug effects
- women’s health