1 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion AUGUS T 2010

Consumer Health Information

www.fda.gov/consumer

Registries Help Moms 

Measure Medication Risks

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.

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.

Thalidomide Tragedy 

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 
2 / FDA Consumer Health Infor mat ion / U. S. Food and Dr ug Adminis t r at ion AUGUS T 2010

Consumer Health Information

www.fda.gov/consumer

Find this and other Consumer 

Updates at www.fda.gov/

ForConsumers/ConsumerUpdates

 Sign up for free e-mail 

subscriptions at www.fda.gov/

consumer/consumerenews.html

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 for bone 

marrow cancer. 

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.

Congress gave FDA the authority 

to require drug makers to study the 

effects of newly approved medicines 

on pregnant and nursing women and 

newborn infants in the FDA Amendments Act of 2007. 

Under the law, FDA experts also 

review applications for new drugs and 

decide if the manufacturer should be 

required to set up a pregnancy registry after approval, says Feibus. 

Sometimes health professionals 

or the drug industry begin a registry 

without being required to do so—as 

in the case of the North American 

Antiepileptic Drug Pregnancy Registry, which studies the effects of drugs 

for the treatment of epilepsy. 

Pregnant women with epilepsy 

are recruited to participate because 

they must take medicines to control 

seizures. The Epilepsy Foundation 

encourages women to enroll in the 

registry, which is closely monitored 

by researchers at Massachusetts General Hospital, the teaching hospital for 

Harvard University Medical School.

“By enrolling, you will help women 

in the future have the best chance of 

a healthy pregnancy and a healthy 

baby,” the foundation tells expectant 

moms in a message on its website.

In May 2008, FDA proposed a new 

rule that includes putting information learned from registries—as well 

as contact information for registries—on labeling for health professionals. The final rule will be published at the end of a multi-stepped 

writing and clearance process.

Registries Aid Moms, Babies

FDA says the registries protect the 

health of mothers and babies because 

• many pregnant women have 

ongoing medical issues that 

require them to continue taking 

drugs during pregnancy 

• new medical problems may begin 

or old ones may get worse 

• a woman’s body changes during 

pregnancy and the changes may 

affect the dosage of a medication 

she is taking

• a woman often takes medications 

while she is breastfeeding, 

potentially exposing her baby to 

the effects of medicines

• about half of the 6 million 

pregnancies in the United 

States each year are unplanned, 

exposing women and developing 

babies to drugs before they know 

they are pregnant

Registries typically collect the woman’s demographics and medications 

being taken. Massachusetts General 

in Boston lists more than 30 medications being studied, and promises the 

process will be quick: one 20-minute 

phone call at the beginning and two 

five-minute calls after that.

In most instances, a woman can 

participate in a pregnancy registry 

by contacting the drug’s maker, her 

physician, or pharmacist. 

Although FDA does not maintain pregnancy registries, the agency’s Office of 

Women’s Health has a partial list on the 

Internet at www.fda.gov/ScienceResearch/

SpecialTopics/WomensHealthResearch/

ucm134848.htm. The list also includes 

the illness each registry represents. 

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.