BACKGROUND: Regulatory agencies often request prospective postauthorization pregnancy exposure registries to monitor medication safety, even though retrospective studies using existing health databases could be used.
OBJECTIVES: We aimed to (1) evaluate the strengths and limitations of existing data sources, including population-based registries and health care databases, that could be used to quantify risks to mother and infant and (2) assess the feasibility of conducting a database study to evaluate these risks in women exposed to intravenous MS-specific medications during pregnancy.
METHODS: A literature review identified data sources used for pregnancy exposure with an outcome of congenital malformations. We abstracted information and contacted data custodians to evaluate each data source for ability to assess the risk of adverse outcomes in women exposed to intravenous disease-modifying therapies (DMTs) during pregnancy.
RESULTS: We identified 21 data sources in the literature capable of mother-offspring record linkage with access to data on maternal medication exposure and congenital malformations. Of these, 13 were viable options for conducting pregnancy safety studies among women with MS because of the data source’s large sample size, the potential to study intravenous DMT exposures, and the ability to identify infant outcomes: 6 claims databases (United States [US], 4; Canada, 1; Germany, 1), 4 medical record databases (US, 3; Scotland, 1), and 3 population-based national registries in Nordic countries. Eleven data sources validate outcomes: 9 use medical record review, 2 use medical record review and registry data.
CONCLUSION: Database studies for drug safety in pregnancy are feasible if enough women are exposed to the treatment of interest. To achieve this, larger databases or combined results from multiple databases are needed to obtain adequate numbers of women with MS exposed to medications during pregnancy and to accommodate internal comparator group(s). Researchers should consider using existing health care databases and national registries to evaluate the safety of new medications among women with MS with exposure to DMTs during pregnancy.
