An update on the OWH pregnancy exposure registry listing

With 50 percent of American pregnancies unplanned, women unwittingly expose their fetus to medication, possibly affecting its health. In 2002, lack of data regarding drug effects on fetal health prompted the Food and Drug Administration (FDA) to issue a guidance regarding the merits and design of a pregnancy exposure registry (PER). A PER is a prospective observational study that collects health information on the woman and her fetus when exposed to a drug or biologic product (e.g. vaccine). The need for such a study increases when there is potential for harm due to in-utero exposure. In 2006, FDA's Office of Women's Health (OWH) updated their web listing of PERs. The OWH web listing is the only centralized location listing all PERs. It serves as an access point for pregnant women and their health care providers, facilitating enrollment and providing information on each study. Forty-one products requiring a PER by the FDA were identified. Of these, 17 were already listed, one was withdrawn from the market and one was released from the requirement. The remaining 22 registries were researched. Nine had unobtainable information, four completed registries were removed, and 13 new registries were added. Currently 32 PERs are listed; six specific to a medical condition and 26 specific to a medical product. The drug exposure information collected provides women and health practitioners margins of reassurance on risk of drug exposure. Through requiring and listing PERs, the FDA and OWH advocate for evidence based medicine to understand drug exposure effects during pregnancy.