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Risk of Non-Cardiac Congenital Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis

    Basic Details
    Date Posted
    Medical Product
    Health Outcome(s)
    non-cardiac congenital malformations

    This analysis estimated the association between use of armodafinil or modafinil during the first trimester of pregnancy compared to use of active comparator medical products (amphetamines or methylphenidate) or to an unexposed comparison group and non-cardiac congenital malformations in a cohort of pregnant individuals and their matched infants in the Sentinel Distributed Database (SDD). This is a follow up to a previous analysis that assessed the risk of cardiac congenital malformations following armodafinil or modafinil use during the first trimester of pregnancy. 

    The study period includes data from January 1, 2000 to December 31, 2022. We distributed this request to four Sentinel Data Partners on August 11, 2023.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation. 

    Additional Details
    FDA Center
    Time Period
    January 1, 2000 – December 31, 2022
    Analysis Type
    Retrospective Inferential
    Population / Cohort
    Females 10 to 54 years of age with evidence of a live birth linked to an infant record
    Data Sources
    Sentinel Distributed Database (SDD)