gynecology and obstetrics
Drug Safety in Pregnancy
Regulatory Information about Drug Safety During Pregnancy
Until the 2010s, the U.S. Food and Drug Administration (FDA) classified over-the-counter (OTC) and prescription drugs into 5 categories of safety for use during pregnancy (A, B, C, D, X). However, few well-controlled studies of therapeutic drugs have been done in pregnant women. Most information about drug safety during pregnancy is derived from animal studies, uncontrolled studies, and postmarketing surveillance. Consequently, the FDA classification system led to confusion and difficulty applying available information to clinical decisions. In December 2014, the FDA responded by requiring that the pregnancy categories A, B, C, D, and X be removed from the labeling of all drugs. Instead of categories, the FDA now requires that drug labels provide information about the specific drug in a consistent format (called the final rule, orPregnancy and Lactation Labeling (Drugs) Final Rule[PLLR]). The information required by the FDA has 3 subsections: Pregnancy:Information relevant to the use of the drug in pregnant women (eg, dosing, fetal risks) and information about whether there is a registry that collects and maintains data on how pregnant women are affected by the drug Lactation:Information about using the drug while breastfeeding (eg, the amount of drug in breast milk, potential effects on the breastfed child) Females and males of reproductive potential:Information about pregnancy testing, contraception, and infertility as it relates to the drug The pregnancy and lactation subsections each include 3 subheadings (risk summary, clinical considerations, and data) that provide more detail. The final rule does not apply to nonprescription (over-the-counter) drugs. 