The chapter provides some summary data on some of the medications and substances that may be taken by the mother during pregnancy and/or breast feeding. Regardless of the designated risk category or presumed safety, no drug or substance should be used during pregnancy and/or breast feeding unless it is clearly needed and the potential benefits clearly outweigh the risks. The table lists the generic medication name and, in parentheses, the US Food and Drug Administration (FDA) fetal risk category followed by the breast-feeding compatibility. At the present time, there is no formally FDA-sanctioned breast-feeding category, and the system used here is discussed later. Lastly, any reported effects on lactation or on infant effects based on breast milk consumption are noted. The editorial board has made an attempt to summarize the data based on the best information available for an individual agent where sources disagree. These data are subject to change as new information becomes available. The reader is advised to consult the FDA (www.fda.gov) and manufacturer’s website for the latest information concerning risks of these medications. The FDA developed a revised labeling that replaces the old 5-letter (A, B, C, D, X) system with more helpful information about a medication’s risks to the expectant mother, the developing fetus, and the breast-fed infant. The labeling changes went into effect on June 30, 2015, for all new drugs, which will use the new format immediately, whereas labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually. Lactation will include (1) risk summary; (2) clinical considerations; and (3) data. This project will take several years to complete. Labeling for over-the-counter (OTC) medicines will not change.
US FDA FETAL RISK CATEGORIES
Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy; there is no evidence of risk in the last 2 trimesters.
Animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women.
Animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester of pregnancy, and there is no evidence of risk in the last 2 trimesters.
Animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans. The benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
There are no animal reproduction studies and no adequate studies in humans.
There is evidence of human fetal risk, but the potential benefits ...