Omalizumab or Montelukast Use Among Individuals with Asthma and Acute Myocardial Infarction, Stroke, Intracranial Hemorrhage, or Pulmonary Embolism

    Basic Details
    Date Posted
    Tuesday, June 21, 2016
    Status
    Complete
    Medical Product
    omalizumab
    Health Outcome(s)
    acute myocardial infarction (AMI)
    intracranial hemorrhage
    stroke
    Description
    Modular program-based one-time assessment of diagnoses of acute myocardial infarction (AMI), stroke, intracranial hemorrhage (ICH), and pulmonary embolism (PE) among omalizumab or montelukast users who were diagnosed with asthma and exposed to inhaled corticosteroids (ICS) only (and excluding long-acting beta agonists (LABA) use) or ICS/LABA products (as combinations or concomitantly as separate products) prior to the omalizumab or montelukast exposures. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of June 23, 2003 to May 31, 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 June 2014. This report includes data from 18 Data Partners.
     
    If you are using a web page screen reader and are unable to access this document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@mini-sentinel.org.
     
    The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Mini-Sentinel pilot in the public domain as soon as possible. Please read the disclaimer.

     

    Additional Details
    FDA Center
    CDER
    Time Period
    June 23, 2003 - May 31, 2013
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals with pre-existing asthma
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)