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New Use of Statins and Rhabdomyolysis

    Basic Details
    Date Posted
    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
    Analysis Type
    Mini-Sentinel
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)