New Use of Anti-Epileptic Drugs and Agranulocytosis

    Basic Details
    Date Posted
    Tuesday, June 21, 2016
    Status
    Complete
    Medical Product
    anti-epileptic drug (AED)
    carbamazepine
    lamotrigine
    levetiracetam
    topiramate
    Health Outcome(s)
    absolute neutrophil count (ANC)
    agranulocytosis
    Description

    Modular program-based one-time assessment of diagnoses of agranulocytosis, Absolute Neutrophil Count (ANC) laboratory results, and agranulocytosis diagnoses within 14 days of an ANC result following new use of several anti-epileptic drugs. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to June 30, 2013. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 1.0; click here for more information. Queries were distributed in August 2014. This report includes data from 10 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, 2006 - June 30, 2013
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)