Posted 11 January 2016
By Michael Mezher
A recent study finds an association between regulatory actions by the US Food and Drug Administration (FDA) and the use of long-acting β2-agonists (LABA) commonly used to treat asthma.
The study, published in the Journal of Allergy and Clinical Immunology in December, was conducted by a team of researchers at Kaiser Permanente, Harvard Medical School, Vanderbilt University and several FDA offices.
In the study, the authors observed a slight, but statistically significant, decrease in the use of LABA-containing products after FDA issued alerts and required new warnings to be included in the products' labels.
FDA approved the first LABA, salmeterol, the active ingredient in the Serevent Diskus, in 1994 under priority review. FDA would go on to approve other products containing salmeterol and formoterol, another LABA, as monotherapy or in combination with an inhaled corticosteroid (ICS).
Then in 2005 and 2010, FDA issued safety alerts for LABA-containing products after new data showed the products carried an increased risk of serious side effects and asthma-related death.
In both years FDA required labeling changes, including a black box warning, to reflect these risks and inform patients and healthcare providers of new recommendations for using products containing LABAs.
In the 2010 alert FDA also said it would require a risk evaluation and mitigation strategy (REMS) for LABA-containing products, and would require manufacturers to conduct postmarketing studies to "further evaluate the safety of LABAs when used in combination with inhaled corticosteroids."
To conduct the study, the authors used data for more than 1.5 million patients sourced from FDA's Mini-Sentinel program, a system used by the agency to monitor drug safety, to observe trends in asthma medication (or non-medication) in patients between January 2005 and June 2011.
The study found a significant decrease in the use of fixed-dose ICS-LABA containing products immediately after FDA's actions in 2005, by 13.55% and 7.42% in children and adults, respectively.
The study also found that FDA's actions did not have an immediate effect on LABA monotherapy in children, though the authors observed a slight downward slope (-0.024) that flattened out over the course of the study.
While the shifts observed were small, the authors find FDA's actions in 2005 likely contributed to less LABAs being prescribed, especially in pediatric populations.
Changing Patterns of Asthma Medication Use Related to US Food and Drug Administration Long-Acting β2-Agonist Regulation from 2005-2011