Will include two subsections: one on pregnancy and one on lactation. Each subsection will include three principle components: risk summary, clinical considerations, and a data section.
1. Risk Summary: Four types of developmental abnormalities addressed (based on animal or human data).
- Structural anomalies
- Fetal and infant mortality
- Impaired physiologic function
- Alterations in growth
2. Clinical Considerations: address three main topics important when counseling with, and prescribing for, women who are pregnant, lactating, or of childbearing age.
- Inadvertent exposure: known or predicted risk to fetus (date on dose, timing, and duration of exposure)
- Prescribing decisions for pregnant women:
- Risk to the pregnant woman and the fetus from the disease the drug is indicated to treat
- Dosing adjustments during pregnancy
- Adverse reactions unique to pregnancy associated with use of the drug.
- Any interventions that may be needed (e.g., monitoring blood glucose for a drug that causes hyperglycemia in pregnancy)
- Any complications in the neonate associated with drug use, including severity and reversibility, and interventions needed
- Drug effects during labor or delivery:
- Effect of the drug on the mother; the fetus/neonate
- Duration of labor and delivery
- Possibility of complications, including needed interventions; and the later growth, development, and functional maturation of the child
3. Data Section:
- A description of the types of studies
- Animal species used
- Dose exposure information (animal doses described in terms of human dose equivalents)
- Nature of any identified fetal developmental anomalies and other adverse events
- For animal data, an explanation of what is known about the relationship between drug exposure and mechanism of action in animals versus humans.
Reference: US Department of Health and Human Services