FDA curbs LABA use for asthma

March 15, 2010

FDA recommended drastic changes limiting the way long-acting beta2-adrenergic agonists are used to treat asthma.

On February 18, FDA recommended drastic changes limiting the way long-acting beta2-adrenergic agonists (LABAs) are used to treat asthma. This decision was based upon an analysis of data from a surveillance study (Salmeterol Nationwide Surveillance Study; SNS), a large randomized trial (Salmeterol Multicenter Asthma Research Trial; SMART), and a meta-analysis of patient data.

LABAs increase the risk of severe exacerbation of asthma symptoms, which can lead to more hospitalizations or even death in both pediatric and adult patients receiving these drugs. FDA estimates that the death rate connected with LABA use is about three times higher than for patients not treated with a LABA.

Currently two LABAs have FDA marketing approval for the treatment of asthma - salmeterol (the active ingredient in Serevent Diskus, Glaxo Group Ltd.; Advair Diskus, GlaxoSmithKline; Advair HFA, GlaxoSmithKline) and formoterol (the active agent in Foradil, Novartis and Symbicort, AstraZeneca). The LABA arformoterol (Brovana, Sepracor) is also available in the United States; however, it is indicated only for the treatment of chronic obstructive pulmonary disease. Each of these agents works by relaxing smooth muscle in the respiratory tract, allowing patients to breath easier and lessening asthma symptoms, such as shortness of breath and wheezing.