PROMPT: Mirabegron Surveillance

    Basic Details
    Date Posted
    Tuesday, September 20, 2016
    Status
    Discontinued
    Medical Product
    mirabegron
    oxybutynin
    Health Outcome(s)
    acute myocardial infarction (AMI)
    stroke
    Description

    Prospective routine observational monitoring assessment of selected safety outcomes (acute myocardial infarction and stroke) in adults who are new users of mirabegron, with oxybutynin as the comparator. This assessment will utilize Mini-Sentinel’s Prospective Routine Observational Monitoring Programming Tools (PROMPT) surveillance system. Click here for more information about PROMPT.

    The Mini-Sentinel Operations Center posted this final draft surveillance plan for public comment from May 1, 2014 through May 15, 2014. The public comment period is now closed. Revised versions were approved for implementation by FDA on June 11, 2014, and September 19, 2016. A log of changes is included in the revised surveillance plan (v3.0).

    Additional Details
    FDA Center
    CDER
    Time Period
    November 1, 2012 - May 30, 2014
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals 20 years of age and older
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Charles E. Leonard PharmD, MSCE; Sean Hennessy PharmD, PhD; Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

    Marsha Reichman PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Members

    Darren Toh ScD; Martin Kulldorff PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Jennifer C. Nelson PhD; Group Health Research Institute, Seattle, WA

    Joshua J. Gagne PharmD, ScD; Shirley V. Wang PhD, ScM; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Rita P. Ouellet-Hellstrom PhD, MPH; David G. Moeny RPh, MPH; Katrina A. Mott MHS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Kunthel By PhD, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD