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

Project Title Omalizumab or Montelukast Use Among Individuals with Asthma and Acute Myocardial Infarction, Stroke, Intracranial Hemorrhage, or Pulmonary Embolism
Date Posted
Tuesday, June 21, 2016
Project ID
to09y05_mpr_wp35_v01
Status
Complete
Deliverables
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.
 
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Medical Product
omalizumab
Health Outcome
acute myocardial infarction (AMI)
intracranial hemorrhage
stroke
Population / Cohort
All individuals with pre-existing asthma
Time Period
June 23, 2003 - May 31, 2013
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER