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

Jennifer G LyonsElizabeth A SuarezElnara Fazio-EynullayevaJudith C MaroCatherine CoreyJie LiSengwee TohMayura U Shinde

Published in: Pharmacoepidemiology and drug safety (2022)

We found an increased risk of oral clefts after topiramate exposure in the first trimester in the Sentinel database. These results are similar to prior published observational study results and demonstrate the ability of Sentinel's data and analytic tools to assess medical product safety in cohorts of mother-infant pairs in a timely manner. This article is protected by copyright. All rights reserved.

Keyphrases

healthcare
electronic health record
randomized controlled trial
emergency department
systematic review
big data
data analysis
artificial intelligence