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Assessing Medical Product Safety During Pregnancy using Parameterizable Tools in the Sentinel Distributed Database

    Basic Details

    The US Food and Drug Administration established the Sentinel System to monitor the safety of medical products. A component of this system includes parameterizable analytic tools to identify mother-infant pairs and evaluate infant outcomes to enable the routine monitoring of the utilization and safety of drugs used in pregnancy. We assessed the feasibility of using the data and tools in the Sentinel System by assessing a known association between topiramate use during pregnancy and oral clefts in the infant. We identified mother-infant pairs using the mother-infant linkage table from six Data Partners contributing to the Sentinel Distributed Database from January 1, 2000, to September 30, 2015. We compared mother-infant pairs with first-trimester exposure to topiramate to mother-infant pairs that were topiramate-unexposed or lamotrigine-exposed and used a validated algorithm to identify oral clefts in the infant. We estimated adjusted risk ratios through propensity score stratification.


    Jennifer G. Lyons, Elizabeth A. Suarez, Elnara Fazio-Eynullayeva, Judith C. Maro, Catherine Corey, Jie Li, Sengwee Toh, Mayura U. Shinde

    Corresponding Author

    Jennifer G. Lyons; Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA