Medication history-wide association studies for pharmacovigilance of pregnant patients

Anup P. Challa*, Xinnan Niu, Etoi A. Garrison, Sara L. Van Driest, Lisa M. Bastarache, Ethan S. Lippmann, Robert R. Lavieri, Jeffery A. Goldstein, David M. Aronoff*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


Background: Systematic exclusion of pregnant people from interventional clinical trials has created a public health emergency for millions of patients through a dearth of robust safety data for common drugs. Methods: We harnessed an enterprise collection of 2.8 M electronic health records (EHRs) from routine care, leveraging data linkages between mothers and their babies to detect drug safety signals in this population at full scale. Our mixed-methods signal detection approach stimulates new hypotheses for post-marketing surveillance agnostically of both drugs and diseases—by identifying 1,054 drugs historically prescribed to pregnant patients; developing a quantitative, medication history-wide association study; and integrating a qualitative evidence synthesis platform using expert clinician review for integration of biomedical specificity—to test the effects of maternal exposure to diverse drugs on the incidence of neurodevelopmental defects in their children. Results: We replicated known teratogenic risks and existing knowledge on drug structure-related teratogenicity; we also highlight 5 common drug classes for which we believe this work warrants updated assessment of their safety. Conclusion: Here, we present roots of an agile framework to guide enhanced medication regulations, as well as the ontological and analytical limitations that currently restrict the integration of real-world data into drug safety management during pregnancy. This research is not a replacement for inclusion of pregnant people in prospective clinical studies, but it presents a tractable team science approach to evaluating the utility of EHRs for new regulatory review programs—towards improving the delicate equipoise of accuracy and ethics in assessing drug safety in pregnancy.

Original languageEnglish (US)
Article number115
JournalCommunications Medicine
Issue number1
StatePublished - Dec 2022

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Internal Medicine
  • Epidemiology
  • Medicine (miscellaneous)
  • Assessment and Diagnosis


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