Whether it’s because of the flu or seasonal allergies, diabetes or epilepsy, pregnant women must often take prescription medication—usually while worrying about the potential impact on their developing babies.
With studies showing the average woman takes from three to five medications while pregnant, the Food and Drug Administration (FDA) encourages drug makers and moms-to-be to participate in pregnancy registry studies that track the risks from drugs taken during pregnancy or breastfeeding.
Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Q: How does FDA define “children”?
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
These studies collect and maintain data on the effects of medications used by pregnant and nursing women on themselves and their babies. Participants don’t take experimental drugs or medications they would not ordinarily take. Instead, registries collect information on the effects of already approved drugs—for diabetes, migraines, epilepsy, and other health issues—prescribed to pregnant women. The information is then compared to the effects of the drug on women who are not pregnant.
“The FDA’s goal is to have data about the use of medicines during pregnancy for all medicines that are used by women of childbearing potential,” says Karen Feibus, M.D., an FDA expert in maternal health.
The effects of the drug thalidomide caused one of the great tragedies of the 1950s. As many as 10,000 babies around the world were born with severe deformities after their mothers took the medication for morning sickness and insomnia.
The drug was marketed in Europe, Japan, Australia, and Canada, but it was taken off the market in the early 1960s when the medical community learned that it caused serious birth defects. According to the March of Dimes, about 40 percent of babies exposed to the drug died before or soon after delivery.
FDA medical officer Frances Kelsey refused to support the drug’s approval in the U.S. because she was uncertain about its safety. Because of this, most babies affected by thalidomide were born in other countries.
FDA approved the drug in 1998 for treatment of a skin disorder associated with Hansen's disease, also called leprosy and later from bone marrow cancer, but there are restrictions.
Registries now collect information on the effects of numerous medications on pregnant women and infants in an effort to identify and manage risks—and prevent tragedy.
Registry Use Expands
“Pregnancy registries are useful tools for gathering information about the effects of drugs on pregnant or nursing women and developing infants,” says Dr. Lisa Mathis, director of FDA’s pediatric and maternal health division.
With registries collecting information on treatments for a range of illnesses—HIV/AIDS, cancer, diabetes, and asthma, Feibus says the data help women make informed choices.
“Sometimes leaving a serious medical condition untreated during pregnancy can be riskier to the mother and her developing baby than the medicine itself,” she says.