Anti-epileptic Drugs and Angioedema

    Basic Details
    Date Posted
    Monday, July 17, 2017
    Status
    Complete
    Medical Product
    lacosamide
    lamotrigine
    levetiracetam
    oxcarbazepine
    phenytoin
    Health Outcome(s)
    angioedema
    Description

    Modular program-based one-time assessment of incidence rates of angioedema among new users of oral levetiracetam and four other oral anti-epileptic drugs (AEDs). This query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2008 to December 31, 2014. Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Analysis (CIDA) tool, version 2.0.8. This query was distributed in October 2015. This report includes data from 15 Data Partners.

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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2008 - December 31, 2014
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)