Antiepileptic Drugs (AEDs) and Kidney Stones 2

    Basic Details
    Date Posted
    Tuesday, September 23, 2014
    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.

    If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.

    The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2004 - December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)