Oxicam NSAIDs, Modafinil/Armodafinil, Sulfamothoxazole and Severe Cutaneous Adverse Reaction (SCAR) Events

    Basic Details
    Date Posted
    Friday, June 7, 2013
    Status
    Complete
    Medical Product
    modafinil
    modafinil/armodafinil
    oxicam
    sulfamothoxazole
    Health Outcome(s)
    severe cutaneous adverse reaction (SCAR)
    Description

    Modular program-based one-time assessment of Severe Cutaneous Adverse Reaction (SCAR) events among incident users of three different drug classes and drugs, including oxicam NSAIDs, modafinil/armodafinil, and sulfamothoxazole, in the Mini-Sentinel Distributed Datebase. Two main categories of counts were generated: 1) incident counts with respect to each of the medications, and 2) frequency of SCAR events for each exposure group per 1000 person-days at risk [January 2000 – May 2011]. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Programs were executed in July 2011.

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    Additional Details
    FDA Center
    CDER
    Time Period
    2000 - 2011
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)