New Use of Statins and Rhabdomyolysis

    Basic Details
    Date Posted
    Thursday, June 30, 2016
    Status
    Complete
    Medical Product
    atorvastatin
    fluvastatin
    lovastatin
    pitavastatin
    pravastatin
    rosuvastatin
    simvastatin
    statin
    Health Outcome(s)
    rhabdomyolysis
    Description

    Modular program-based one-time assessment of rhabdomyolysis events following new use of statins, including atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2006 to May 31, 2013.  Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information.  Queries were distributed in June 2014. This report includes data from 12 Data Partners.
     
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    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2006 - May 31, 2013
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)