FDA Provides List of Pregnancy Exposure Registries

By Rachel Walden — May 28, 2008

Determining the safety of medications during pregnancy can be difficult, with pregnant women needing to weigh the benefits of a potential medicine to themselves with the potential risks to the fetus. The Organization of Teratology Information Specialists has compiled numerous fact sheets on specific medicines in pregnancy and breastfeeding, and the LactMed database focuses on possible effects of substances (including over-the-counter products) while breastfeeding.

Pregnancy exposure registries collect data from women who have been exposed to a specific drug during pregnancy in order to study possible effects on fetal health. In some cases, the FDA requires that a drug company set up a registry – you may remember the FDA requiring women taking Accutane to register and assert that they would use contraception.

The FDA’s Office of Women’s Health is now maintaining a list of such registries, including some for HIV/AIDS medications, the HPV and hepatitis B vaccines, and drugs for depression, migraines, diabetes, and other conditions. ClinicalTrials.gov is another searchable source of fetal exposure studies and registries for women interested in participating.

Some registries require women to sign up through their health care providers, and it’s important to remember that these are research studies – participants may be required to complete multiple interviews and should be fully informed prior to agreeing to enroll. The registries also are not generally designed to determine whether the drugs have any unusual effects on women during pregnancy, but typically focus on fetal effects. Additionally, the registries typically focus on branded drugs, but registries for other exposures (such as environmental concerns) are very limited. Because clinical drug trials typically exclude pregnant women, however, these registries are one way to collect information on whether a drug is safe for pregnant women and their fetuses.

Update: This week the FDA proposed a new rule for prescription drug labeling with the intent of providing clearer information on drug effects on pregnancy and breastfeeding. The new system would remove the mysterious letter categories for describing pregnancy-related risks and would add new sections to labels to describe fetal risk and other considerations. Public comments on the proposed rule are being accepted through August 27, 2008.

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