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FDA's Proposed Rule on Pregnancy and Lactation Labeling

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