Pregnancy research has been a cornerstone of our work, including traditional drug safety studies on teratogenic risk, the evaluation of drug use during pregnancy and related policy, and development of research and analytic methods to enhance the rigor of this work.
Drug safety studies
Drug safety in pregnancy
Drug use during pregnancy is ubiquitous but for most drugs we don't know whether their risk-benefit is favorable. Most medications have incomplete evidence on teratogenic risk, and benefits of using a medication during pregnancy versus an alternative, if available, are poorly understood. We aim to address both the risk and benefit of medications during pregnancy and the consequences of prenatal exposure for children to support the difficult decision that women, clinicians and regulators face when deciding whether to (recommend) use of a medication during pregnancy. Besides the potentially life-long consequences for the children we are equally interested in maternal health.
Key publications
- Winterstein AG, Thai TN, Nduaguba S, Smolinski NE, Wang X, Sahin L, Krefting I, Gelperin K, Bird ST, Rasmussen SA. Risk of fetal or neonatal death or neonatal intensive care unit admission associated with gadolinium magnetic resonance imaging exposure during pregnancy. Am J Obstet Gynecol. 2022 Oct 11:S0002-9378(22)00809-2.
- Thai TN, Sarayani A, Wang X, Albogami Y, Rasmussen SA, Winterstein AG. Risk of pregnancy loss in patients exposed to mycophenolate compared to azathioprine: A retrospective cohort study. Pharmacoepidemiol Drug Saf. 2020 Jun;29(6):716-724.
Drug use and Policy
Drug use in pregnancy
While the evidence on drug risk benefit during pregnancy needs more work, there is solid evidence supporting the notion that certain drugs should NOT be used. However, prenatal exposure to teratogenic drugs remains common and a major contributor to negative pregnancy outcomes including pregnancy loss and malformations. We work to understand when and why this happens and how clinical practice and policy can be changed to ensure healthy pregnancies.
Key publications
- Sarayani A, Albogami Y, Thai TN, Smolinski NE, Patel P, Wang Y, Nduaguba S, Rasmussen SA, Winterstein AG. Prenatal exposure to teratogenic medications in the era of Risk Evaluation and Mitigation Strategies. Am J Obstet Gynecol. 2022 Aug;227(2):263.e1-263.e38.
- Sarayani A*, Hampp C, Brown JD, Donahoo WT, Winterstein AG. Topiramate Utilization After Phentermine/Topiramate Approval for Obesity Management: Risk Minimization in the Era of Drug Repurposing. Drug Saf. 2022 Dec;45(12):1517-1527
Research methods development
Methods in child & maternal health research
Research in drug exposure and outcomes during pregnancy considering maternal and infant outcomes comes with many methodological challenges in design, measurement and analysis. We are trying to tackle some of these challenges…
Key publications
- Sarayani A, Wang X, Thai TN, Albogami Y, Jeon N, Winterstein AG. Impact of the Transition from ICD-9-CM to ICD-10-CM on the Identification of Pregnancy Episodes in US Health Insurance Claims Data. Clin Epidemiol. 2020 Oct 15;12:1129-1138.
- Knox CA, Hampp C, Palmsten K, Zhu Y, Setoguchi S, Brumback B, Segal R, Winterstein AG. Validation of mother-infant linkage using Medicaid Case ID variable within the Medicaid Analytic eXtract (MAX) database. Pharmaoepidem Drug Saf 2019 Sep;28(9):1222-1230.
- Choi Y, Park H, Hampp C, Brumback B, Meissner HC, Li Y, Roussos-Ross D, Zhu Y, Henriksen C, Winterstein AG. Usability of encounter data for Medicaid comprehensive managed care vs traditional Medicaid fee-for-service claims among pregnant women. Pharmacoepidemiol Drug Saf. 2019 Jan;29(1):30-38.