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Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System

    Basic Details

    It is a priority of the US Food and Drug Administration (FDA) to monitor the safety of medications used during pregnancy. Pregnancy exposure registries and cohort studies utilizing electronic health record data are primary sources of information but are limited by small sample sizes and limited outcome assessment. TreeScan™, a statistical data mining tool, can be applied within the FDA Sentinel System to simultaneously identify multiple potential adverse neonatal and infant outcomes after maternal medication exposure. We implemented TreeScan using the Sentinel analytic tools in a cohort of linked live birth deliveries and infants nested in the Merative™ MarketScan® Research Databases. As a case study, we compared first trimester fluoroquinolone use and cephalosporin use. We used the Bernoulli and Poisson TreeScan statistics with compatible propensity score-based study designs for confounding control (matching and stratification) and used multiple propensity score models with various strategies for confounding control to inform best practices. We developed a hierarchical outcome tree including major congenital malformations and outcomes of gestational length and birth weight.


    Elizabeth A Suarez, Michael Nguyen, Di Zhang, Yueqin Zhao, Danijela Stojanovic, Monica Munoz, Jane Liedtka, Abby Anderson, Wei Liu, Inna Dashevsky, David Cole, Sandra DeLuccia, Talia Menzin, Jennifer Noble, Judith C Maro

    Corresponding Author

    Elizabeth A Suarez; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA