1 / FDA Consumer Health Information / U.S. Food and Drug Administration DECEMBER 2014

Consumer Health Information

www.fda.gov/consumer

Registries Help Inform 

Medication Use in Pregnancy

Whether it’s because of the 

flu or seasonal allergies, 

diabetes or epilepsy, 

pregnant women must often take 

prescription medication. Studies 

show that most women take 

at least one medication while 

pregnant, and that the use of 

four or more medications during 

pregnancy has more than doubled 

over the last 30 years.

Pregnant women who are prescribed a drug may worry about the 

potential impact on their developing 

fetuses. Sometimes, these effects 

are known. However, there is often 

a lack of information on the effects 

of a particular drug taken during 

pregnancy and one way to obtain 

it is through a pregnancy registry. 

FDA encourages moms-to-be to 

participate in pregnancy registry 

studies that track the outcomes of 

drugs taken during pregnancy.

Participants enrolled in a pregnancy registry study are not taking 

experimental drugs. Instead, pregnancy registries collect data on the 

effects of already approved drugs—

prescribed to women for a specific 

disease or condition.

The information collected in 

pregnant women taking the drug is 

then compared to the information 

in pregnant women with the same 

condition who are not taking that 

drug. For example, a pregnancy 

registry may compare birth defects 

in pregnant women who took an 

antidepressant with birth defects in 

pregnant women who did not take 

an antidepressant.
2 / FDA Consumer Health Information / U.S. Food and Drug Administration DECEMBER 2014

Consumer Health Information

www.fda.gov/consumer

“The FDA’s goal is to have data 

about the safety of medicines 

during pregnancy that can be used 

for labeling,” says Sandra Kweder, 

M.D., deputy director of the Office 

of New Drugs.

How Registries Work

“Pregnancy registries are useful 

tools for gathering information 

about the effects of drugs on pregnant women and their developing 

fetuses,” says Dr. Lynne Yao, acting 

director of FDA’s Division of Pediatric and Maternal Health.

The data collected from pregnancy 

registries cover a broad range of treatments as well as vaccines. Yao says 

these data help prescribers and pregnant women make informed choices.

“Often, leaving a serious medical 

condition untreated during pregnancy can be riskier to the mother 

and her developing fetus than the 

medicine itself,” she says.

FDA can require a manufacturer 

to establish a pregnancy registry 

after a new medicine or vaccine has 

been approved, says Yao. However, 

academic centers may also establish 

a pregnancy registry — as in the case 

of the North American Antiepileptic 

Drug Pregnancy Registry, which 

studies the effects of drugs for the 

treatment of epilepsy. Regardless of 

the group conducting a pregnancy 

registry, the goal of a pregnancy 

registry is to collect information 

that may be used in product 

labeling so that the prescriber and 

pregnant woman can make more 

informed decisions about the use of 

a medication during pregnancy.

Registries typically collect information about the woman’s demographics and the medications she is taking. 

For example, the North American 

Antiepileptic Drug Pregnancy Registry website lists more than 30 medications being studied, and promises 

the process will be quick: a 20-minute 

phone call at the beginning, a fiveminute call when you are 7 months 

pregnant, and a 10 minute phone call 

after your baby is born.

In December, 2014, FDA issued a 

new labeling rule that requires the 

inclusion of contact information 

for pregnancy registries in labeling. 

This will enable the physician and 

the pregnant woman to participate 

in a registry and contribute valuable 

information to make decisions about 

taking a drug in pregnancy. 

Registries Aid Moms, Fetuses

FDA says the information obtained 

from registries protect the health of 

mothers and fetuses because 

• many pregnant women have 

ongoing medical issues that 

require them to continue taking 

drugs during pregnancy 

• new medical problems may begin 

or ongoing ones may get worse

• a woman’s body changes during 

pregnancy and the changes 

may affect the safety and/or 

effectiveness of a medication she 

is taking

• about half of the 6 million 

pregnancies in the United States 

each year are unplanned, exposing 

women and their developing 

fetuses to drugs before the women 

know they are pregnant

• enrolling in a registry will help 

increase the knowledge of the use 

of a medication during pregnancy 

so that pregnant women have 

the best chance of a healthy 

pregnancy and a healthy baby

FDA does not actually conduct 

pregnancy registries itself. However, 

the Agency’s Office of Women’s Health 

has a list of pregnancy registries 

that are enrolling pregnant women 

at www.fda.gov/ScienceResearch/

SpecialTopics/WomensHealthResearch/

ucm134848.htm.

“Pregnancy registries are useful

tools for gathering information about the 

effects of drugs on pregnant women and 

their developing fetuses.” 

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