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Antiepileptic Drugs (AEDs) and Kidney Stones 2

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

    Modular program-based one-time assessment of incidence of kidney stones following new use of anti-epileptic medications among all exposed patients and among those with a pre-existing condition of epilepsy and those with an exclusion of pre-existing anti-diabetic agent exposure. The query was run against the Mini-Sentinel Distributed Database (MSDD) for a time period of January 1, 2004 – December 31, 2012. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 5.0; click here for more information.  Queries were distributed in August 2013. This report includes data from 18 Data Partners.

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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2004 - December 31, 2012
    Analysis Type
    Mini-Sentinel
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)