Evaluating safety of long-acting beta agonists (LABAs) in patients with asthma.

The introduction of long-acting beta agonists (LABAs) was considered a major advance in bronchodilator therapy with evidence that their use led to improved lung function and quality of life. However, the use of LABAs has raised safety concerns, such as their potential to provoke severe asthma exacerbations (SAEs) and death. This systematic review of major findings discusses the safety controversy surrounding LABA therapy and provides background for the U.S. Food and Drug Administration's warnings concerning LABA use. Findings from large clinical trials and several meta-analyses are described and compared in terms of their implications for the safety of LABAs. Monotherapy LABA therapy in the treatment of asthma remains controversial and is not recommended by the most recent asthma management guidelines. Despite the existence of numerous published studies, we conclude that more well-designed research on this topic --- to determine whether LABAs are associated with SAEs, such as asthma-related hospitalizations, intubations, and emergency room visits, or death --- is required. Particularly needed is research that makes use of large, secondary longitudinal databases.