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

    Basic Details
    Date Posted
    Medical Product
    Health Outcome(s)
    acute myocardial infarction (AMI)
    intracranial hemorrhage
    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.
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    Additional Details
    FDA Center
    Time Period
    June 23, 2003 - May 31, 2013
    Analysis Type
    Population / Cohort
    All individuals with pre-existing asthma
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)