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The Impact of FDA Regulatory Activities on Incident Dispensing of LABA-Containing Medication: 2005-2011

    Basic Details
    Medical Product
    long-acting beta2 agonist (LABA)
    Health Outcome(s)
    change in drug utilization patterns

    Evidence of safety issues associated with long-acting beta2-agonist (LABA) treatment has led to multiple regulatory activities by the U.S. Food and Drug Administration (FDA) on this class of medications.This study describes the impact of the regulatory activities on incident LABA-containing medication dispensing.


    Meghan A. Baker MD, ScD, Melissa G. Butler PharmD, PhD, MPH, Sally Seymour MD, Fang Zhang PhD, Yute Wu PhD, Ann Chen Wu MD, MPH, Mark S. Levenson PhD, Pingsheng Wu PhD, Aarthi Iyer MPH, Sengwee Toh ScD, Solomon Iyasu MD, MPH, Esther H. Zhou MD, PhD

    Corresponding Author

    E. H. Zhou, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Email: