Antiepileptic Drugs (AEDs) and Kidney Stones

    Basic Details
    Date Posted
    Tuesday, January 7, 2014
    Status
    Complete
    Medical Product
    anti-epileptic drug (AED)
    carbamazepine
    gabapentin
    lamotrigine
    levetiracetam
    oxcarbazepine
    phenytoin
    topiramate
    zonisamide
    Health Outcome(s)
    kidney stone
    Description

    Modular program-based one-time assessment of incident use of eight antiepileptic drugs (lamotrigine, levetiracetam, topiramate, carbamazepine, oxcarbazepine, zonisamide, gabapentin, and phenytoin) and a diagnosis of kidney stones.  Each product was analyzed by two unique incidence definitions and two unique kidney stone definitions. The queries were run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2004 to December 31, 2012.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 4.0; click here for more information. Queries were distributed in April/May 2013. These reports include data from 18 Data Partners.

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    Additional Details
    FDA Center
    CDER
    Time Period
    2004-2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)