Quinine Sulfate, Diltiazem and Selected Thrombotic Events

    Basic Details
    Date Posted
    Wednesday, January 8, 2014
    Status
    Complete
    Medical Product
    diltiazem
    quinine sulfate
    Health Outcome(s)
    hemolytic-uremic syndrome
    immune thrombocytopenic purpura
    other secondary thrombocytopenia
    thrombotic microangiopathy
    unspecified thrombocytopenia
    Description

    Modular program-based one-time assessment of incident use of quinine sulfate or diltiazem and outcomes of hemolytic-uremic syndrome, immune thrombocytopenic purpura, unspecified thrombocytopenia, other secondary thrombocytopenia, and thrombotic microangiopathy. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 through December 31, 2010.  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 March/April 2012. This report includes data from 17 Data Partners.

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    Additional Details
    FDA Center
    CDER
    Time Period
    2006 - 2010
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)