The Safety of Medications in Pregnant Women: An Opportunity to Use Database Studies.

Abstract

* Abbreviations: FDA — : Food and Drug Administration NAAEDR — : North American Antiepileptic Drug Registry Information on the safety of medications that pregnant women may need is key to protecting the health of the woman and her fetus. When new drugs are first marketed, this information is scarce, because pregnant women are generally excluded from randomized clinical trials. Broader inclusion of pregnant women in clinical research is being discussed by regulatory authorities and funders.1 But even with greater inclusion of pregnant women in clinical trials, safety data from those trials would be limited by the combination of study size, low frequency of many key outcomes, and strict conditions for enrollment. Postapproval observational studies still would be needed to assess drug safety in routine health care. These assessments can be conducted as pregnancy exposure registries or by using existing health databases. Currently, because of our overreliance on pregnancy exposure registries and underuse of database studies, we are missing an opportunity to provide information that would help women and their physicians make better informed decisions about treatment in pregnancy. Pregnancy exposure registries, usually sponsored by a single pharmaceutical company, are a primary method requested by the US Food and Drug Administration (FDA) for postapproval safety studies in pregnant women.2 However, these registries often fail to enroll a sufficient number of exposed pregnancies, and when they do, it is often difficult to interpret results because they generally do not include an internal comparison cohort and rely on comparisons to external data sources, such as the Metropolitan Atlanta Congenital Defects Program.2 The pregnancy registries that have been most successful in enrolling … Address correspondence to Andrea V. Margulis, MD, ScD, RTI Health Solutions, Diagonal 605, 9-1, 08028 Barcelona, Spain. E-mail: amargulis{at}rti.org