A greater understanding of the safety and efficacy of medications used
during pregnancy is needed to improve the health of mothers and their
In the United States (US), approximately 95% of mothers take medications
or supplements during pregnancy, 65% of which include one or more
prescribed medications. Despite remarkable progress in prenatal and
perinatal care in recent decades, appropriate medication and supplement
use during pregnancy is one of the most neglected areas in the field.
Though US regulatory policy was revised over 20 years ago to promote the
inclusion of pregnant women and children in clinical research, there is
still little information available regarding drug safety and efficacy
Why does pregnancy matter when taking medications?
Pregnancy is complex in that two (or more) individuals (mother and baby)
share pathways and interact while the baby is in the womb and also
after birth, while breastfeeding. In addition, the way the body
processes the drug (called drug metabolism) changes during pregnancy,
requiring adjustments in dosing to maximize benefit and minimize
potential harm. With little information available to guide decision
making, yet a real need to treat the patient for an illness or
condition, care providers often resort to off-label prescribing (use of a
drug in a manner not specified in the FDA’s labeling or package
insert), which could result in unnecessary harm to the mother or her
What is being done to increase understanding?
The Obstetric-Fetal Pharmacology Research Centers (OPRC) Program was established by the Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD) to
support specialized research to improve the safety and efficacy of
medication use during pregnancy and while breastfeeding. These projects
include basic/translational research involving cells and/or animals as
well as clinical studies involving humans, and will better enable
clinicians to protect the health of pregnant women, while improving
birth outcomes and reducing harm to infants.
This website was created and is maintained through funding by the Eunice Kennedy Shriver
National Institute of Child Health and Human Development of the
National Institutes of Health under award number U54HD04789-11. It
serves as a resource for fellow investigators and clinicians as well as
our local community partners, potential study participants and their
family and friends.
We thank you for your interest in and support of this important topic!