Skip to main content

Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Tuesday, November 17, 2020
    Medical Product
    Health Outcome(s)
    congenital cardiac malformations

    In this request we examined characteristics of pregnant women using modafinil or armodafinil, amphetamines, methylphenidate, or who were unexposed to those medical products in the Sentinel Distributed Database (SDD). We distributed this request to six Sentinel Data Partners on March 30, 2020. The study period included data from January 1, 2000 to December 31, 2018.

    Additional Details
    FDA Center
    Time Period
    January 1, 2000 - December 31, 2018
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Females 10 to 54 years of age
    Data Sources
    Sentinel Distributed Database (SDD)