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New Use of Anti-Epileptic Drugs and Agranulocytosis

    Basic Details
    Date Posted
    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.
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2006 - June 30, 2013
    Analysis Type
    Mini-Sentinel
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)