Patterns of asthma medication use related to FDA LABA Regulation

Published Online: December 22, 2015

Long-acting beta2 agonists (LABA) were first marketed in the US for asthma management in 1994. Safety concerns associated with LABA have led to U.S. Food and Drug Administration (FDA) regulatory activities for this class of drugs.  Trends in asthma medication use after the 2005 and 2010 LABA FDA regulatory activities are not well established, and little is known about the impact of these regulatory activities on LABA-containing or other asthma medication use.

In a recently published article in The Journal of Allergy & Clinical Immunology (JACI), Butler and colleagues hypothesized that adherence to the FDA regulatory activities would result in less LABA dispensing. They created rolling cohorts of pediatric and adult asthma patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011 to examine changes in utilization trends of LABA and other asthma medications.

The researchers measured proportions of asthma patients using: LABA-containing products; inhaled corticosteroids (ICS); leukotriene modifiers (LM); short-acting beta2 agonists; oral corticosteroids; other bronchodilators; as well as no medications, on a monthly basis and the changes were evaluated using interrupted time series with segmented regression analysis.

The authors found that when the 2005 regulatory activity was announced, there were statistically significant declines in use of fixed-dose ICS-LABA agents in children (-0.98 percentage points) and adults (-1.24 percentage points). Increased use of ICS and LM were observed just after the regulatory activities were announced in both children and adults. Although of smaller magnitude, continued decreased use of LABA agents were observed following the 2010 FDA regulatory activity.

The authors’ findings suggest decreasing use of LABA-containing products and increasing use of other asthma controller medications during a period of FDA LABA-related regulatory activities from 2005-2011.  The 2005 FDA regulatory activity may have contributed towards less use of LABA agents as intended; however, its effect independent of other factors cannot be determined. Use of other classes of asthma medications was similarly impacted. Although of smaller magnitude, continued decreased use in the use of LABA agents were observed following the 2010 FDA regulatory activity. While these changes appear small in magnitude, they represent thousands of children and adults with asthma using less LABA agents over time.

The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI, and is the most-cited journal in the field of allergy and clinical immunology.

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