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A greater understanding of the safety and efficacy of medications used during pregnancy is needed to improve the health of mothers and their babies.

Pregnancy_and_medicationsIn 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 in pregnancy.

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 baby.

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!