FDA Endorses Registries for Pregnant Women

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The U.S. Food and Drug Administration is urging expecting mothers to take part in pregnancy registries in an effort to better track potential risks associated with drugs taken during pregnancy or breastfeeding.

“Pregnancy registries are useful tools for gathering information about the effects of drugs on pregnant or nursing women and developing infants,” Dr. Lisa Mathis, director of FDA’s pediatric and maternal health division, said in a press release announcing the administration’s endorsement late last week.

The FDA explained that pregnant women often have to take prescription medication for pre-existing or emerging health conditions such as diabetes, epilepsy, seasonal allergies or even the flu. While these prescribed medications are already approved for use, the registry allows potential side effects to be readily captured and/or monitored to prevent possible tragedies.

Certain registries exist for general screening purposes. However, many manufacturers, physicians and organizations who produce or endorse prescriptions for women with serious and/or persistent health conditions, such as HIV/AIDS, cancer, diabetes and asthma, set up registries voluntarily to track the effects of new medications on expectant mothers.

These registries aren’t maintained by the FDA.The North American Antiepileptic Drug Pregnancy Registry, for example, studies the effects of drugs for the treatment of epilepsy. Pregnant women with epilepsy are recruited to participate through the Epilepsy Foundation as they must take medicines to control seizures.

In addition to preventing potential tragedies, information from these registries are intended to help expecting mothers suffering from these types of illnesses make more informed choices about their course of treatment.

“Sometimes leaving a serious medical condition untreated during pregnancy can be riskier to the mother, and her developing baby, than the medicine itself,” Mathis explained.

In its endorsement, the FDA clarified that existing registries do not require that pregnant women take any experimental drugs or prescriptions that they were not already going to take. According to the FDA, women, on average, take three to five medications while pregnant to treat a variety of illnesses. 

Additionally, these registries help women (and their developing babies) exposed to drugs before they know they are pregnant understand and/or treat potential side effects.

The press release cites the unfortunate birth defects caused by the drug thalidomide, used to treat morning sickness and insomnia in the 1950s, as an example of what the registries are attempting to prevent. As many as 10,000 babies worldwide were born with severe deformities after their mothers took the prescribed medication, and about 40% of the babies exposed to the drug died before or soon after delivery.

Pregnant women can participate in a pregnancy registry by contacting the pharmaceutical company, her physician or a local pharmacist. A partial list of existing registries can be found here at the agency’s Office of Women’s Health.

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